Class: Selective Serotonin-reuptake Inhibitors
VA Class: CN609
Chemical Name: trans-(-)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine hydrochloride hemihydrate
Molecular Formula: C19H20FNO3•HCl•½H2O
CAS Number: 110429-35-1
[Posted 12/14/2011] ISSUE: FDA notified healthcare professionals and the public on the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as Persistent Pulmonary Hypertension of the Newborn (PPHN). The initial Public Health Advisory in July 2006 on this potential risk was based on a single published study. Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN.
FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN. FDA will update the SSRI drug labels to reflect the new data and the conflicting results.
BACKGROUND: SSRIs are marketed under various brand and generic drug names, and are used to treat depression and other psychiatric disorders. There are no adequate and well-controlled studies of SSRIs in pregnant women.
PPHN occurs when a newborn baby does not adapt to breathing outside the womb. Newborns with PPHN may require intensive care support including a mechanical ventilator to increase their oxygen level. If severe, PPHN can result in multiple organ damage, including brain damage, and even death.
RECOMMENDATION: FDA advises health care professionals not to alter their current clinical practice of treating depression during pregnancy. See the Data Summary in the FDA Drug Safety Communication for additional information. FDA will communicate any new information on the risk of bleeding and dabigatran when it becomes available. For more information visit the FDA website at: and .
[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. For more information visit the FDA website at: , and .
[Posted 07/19/2006] FDA notified healthcare professionals and consumers of important information from two recent studies that should be considered when making treatment decisions in pregnant women who take antidepressants. The studies included pregnant women who were treated with selective serotonin reuptake inhibitors (SSRIs), or in a few cases, other antidepressant medications.
One study illustrated the potential risk of relapsed depression after stopping antidepressant medication during pregnancy. In this study, women who stopped their medicine were five times more likely to have a relapse of depression during their pregnancy than were women who continued to take their antidepressant medicine while pregnant.
The second study suggests there may be additional, though rare, risks of taking SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth. Babies born with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. In this study, PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk of one drug compared to another. The finding of PPHN in babies of mothers who used a SSRI antidepressant in the second half of pregnancy adds to concerns from previous reports that infants of mothers taking SSRIs late in pregnancy may experience difficulties such as irritability, difficulty feeding and in very rare cases, difficulty breathing.
Additionally, the labeling for paroxetine (Paxil) was recently changed to add information about findings in an epidemiologic study that suggests that exposure to the drug in the first trimester of pregnancy may be associated with an increased risk of cardiac birth defects.
Women who are pregnant or thinking about becoming pregnant should not stop any antidepressant medication without first consulting their physician. The FDA is seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy. FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN. For more information visit the FDA website at: and .
[Posted 07/19/2006] FDA notified healthcare professionals and consumers of new safety information regarding taking medications used to treat migraine headaches (triptans) together with certain types of antidepressant and mood disorder medications (selective serotonin reuptake inhibitors (SSRIs) and selective serotonin/norepinephrine reuptake inhibitors (SNRIs). A life-threatening condition called serotonin syndrome may occur when triptans are used together with a SSRI or a SNRI.
Serotonin syndrome occurs when the body has too much of a chemical found in the nervous system (serotonin). Each of the above medications (triptans, SSRIs, and SNRIs), cause an increase in serotonin levels. Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea.
Healthcare professionals prescribing a triptan, SSRI or SNRI should keep in mind that triptans are often used intermittently and either the triptan, SSRI or SNRI may be prescribed by a different physician; weigh the potential risk of serotonin syndrome with the expected benefit of using the above combination; discuss the possibility of serotonin syndrome with patients if a triptan and an SSRI or SNRI will be used together; and follow patients closely during treatment if a triptan and an SSRI or SNRI are used together.
Patients taking a triptan along with an SSRI or SNRI should talk to their doctor before stopping their medication and should immediately seek medical attention if they experience any of the above symptoms. FDA requested that all manufacturers of triptans, SSRIs and SNRIs update their prescribing information to warn of the possibility of serotonin syndrome when these medications are taken together. For more information visit the FDA website at: and .
- Suicidality in Children and Adolescents
Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder and other psychiatric disorders (see Pediatric Use under Cautions); balance this risk with clinical need.1 311 312 314 315 Paroxetine is not approved for use in pediatric patients.1 312
Closely monitor pediatric patients who are started on paroxetine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.1 312 314 (See Worsening of Depression and Suicidality Risk under Cautions.)
Uses for Paroxetine Hydrochloride
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Major Depressive Disorder
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Efficacy in hospital settings not established.1
Obsessive-Compulsive Disorder (OCD)
Management of generalized anxiety disorder.1
Posttraumatic Stress Disorder (PTSD)
Premenstrual Dysphoric Disorder (PMDD)
Paroxetine Hydrochloride Dosage and Administration
Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of paroxetine, and vice versa.1
Monitor for possible worsening of depression or suicidality, especially at the beginning of therapy or during periods of dosage adjustments.1 312 314 (See Worsening of Depression and Suicidality Risk under Cautions.)
Avoid abrupt discontinuance of therapy;24 184 197 198 200 204 to avoid withdrawal reactions, taper dosage gradually over a period of several weeks.184 194 197 198 200 (See Withdrawal of Therapy under Cautions.)
Shake oral suspension well just prior to administration.1
Swallow extended-release tablets whole; do not chew or crush.304
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Available as paroxetine hydrochloride; dosage expressed in terms of paroxetine.1
Major Depressive Disorder
Optimum duration not established; may require several months of therapy or longer.1 22 42 101 102 103 104 129 130 133 304 Antidepressant efficacy demonstrated for up to 1 year at mean dosage of 30 mg daily as conventional tablets or suspension, which corresponds to a 37.5 mg daily dosage as extended-release tablets.1 133
Optimum duration not established; efficacy has been demonstrated in a 6-month relapse prevention trial.1 Obsessive-compulsive disorder is chronic and requires several months or longer of sustained therapy.1 51 52 May continue therapy in responding patients, 1 51 52 but use lowest effective dosage and periodically reassess need for continued therapy.1
Optimum duration not established; efficacy demonstrated in a 3-month relapse prevention trial.1 48 54 184 May continue therapy in responding patients,1 48 54 184 but use lowest effective dosage and periodically reassess need for continued therapy.1
Conventional tablets or suspension: 20 mg once daily; no additional clinical benefit was observed with higher dosages.1
Long-term efficacy (>12 weeks) not demonstrated; may consider continuation in patient who responds, but use lowest effective dosage and periodically reassess need for continued therapy.1
Conventional tablets or suspension: Initially, 20 mg daily; no additional clinical benefit was observed with higher dosages.1 If needed, dosage may be increased in 10-mg increments at weekly intervals.1
Optimum duration not established; efficacy has been demonstrated in a 24-week relapse prevention trial.1 321 Generalized anxiety disorder is chronic.1 321 May continue therapy in responding patients.1 321 If used for extended periods, adjust dosage so that patients are maintained on lowest effective dosage and periodically reassess need for continued therapy.1
Posttraumatic Stress Disorder
Conventional tablets or suspension: 20 mg daily; insufficient evidence to suggest greater clinical benefit with higher dosages.1 If needed, dosage may be increased in 10-mg increments at weekly intervals.1
Consider alternative therapy if patient fails to achieve ≥25% reduction in PTSD symptoms at week 8.300 If >75% reduction in PTSD symptoms and response maintained for ≥3 months, may consider up to 24 months of drug therapy.300 If used for extended periods, adjust dosage so that patients are maintained on lowest effective dosage and periodically reassess need for continued therapy.1
Premenstrual Dysphoric Disorder
Extended-release tablets: Initially, 12.5 mg once daily; may be administered daily throughout menstrual cycle or only during luteal phase.312 Dosage may be increased in intervals of ≥1 week.312 Dosages of 12.5–25 mg were effective in clinical studies.312
Conventional tablets or suspension: 10–50 mg daily for 3–9 months.164
Major Depressive Disorder
Conventional tablets or suspension: Maximum 50 mg daily.
Conventional tablets or suspension: Maximum 60 mg daily.1
Conventional tablets or suspension: Maximum 60 mg daily.1
Extended-release tablets: 75 mg daily.312
Extended-release tablets: 37.5 mg daily.312
In patients with severe hepatic impairment, an initial dosage of 10 mg daily (as conventional tablets or suspension) or 12.5 mg daily (as extended-release tablets).1 304 If no clinical improvement is apparent, dosage may be titrated with caution up to a maximum of 40 mg daily (for conventional tablets or suspension) or 50 mg (for extended-release tablets).1 98 99 304
In patients with severe renal impairment, an initial dosage of 10 mg daily (as conventional tablets or suspension) or 12.5 mg daily (as extended-release tablets).1 304 If no clinical improvement is apparent, dosage may be titrated with caution up to a maximum of 40 mg daily (for conventional tablets or suspension) or 50 mg (for extended-release tablets).1 98 99 304
Geriatric or Debilitated Patients
Initially, 10 mg daily (as conventional tablets or suspension) or 12.5 mg daily (as extended-release tablets); if no clinical improvement is apparent, dosage may be titrated up to a maximum of 40 mg daily (as conventional tablets or suspension) or 50 mg daily (as extended-release tablets).1 95 304
Cautions for Paroxetine Hydrochloride
Concurrent therapy with thioridazine.1 (See Drug Interactions under Warnings.)
Known hypersensitivity to paroxetine or any ingredient in the formulation.1
Concomitant use of some SSRIs with MAO inhibitor associated with serious, sometimes fatal reactions, including manifestations resembling serotonin syndrome (e.g., hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes) or neuroleptic malignant syndrome (NMS).1 (See Contraindications.)
May inhibit CYP2D6, resulting in increased risk of QT prolongation and/or ventricular tachycardia of the torsades de pointes type associated with elevated plasma concentrations of thioridazine.1 (See Contraindications.)
Worsening of Depression and Suicidality Risk
Possible worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) in both adult and pediatric patients with major depressive disorder; may persist until clinically important remission occurs with therapy.1 312 314
Possible increased risk of suicidal behavior in young adult patients (18–30 years of age), particularly those with major depressive disorder.a b c Increased risk of suicidal behavior and thoughts in patients with a history of suicidal behavior or thoughts and in patients exhibiting a substantial degree of suicidal ideation prior to initiating therapy.a b c Increased risk of suicidal behavior was observed despite evidence of paroxetine efficacy in patients being treated for major depressive disorder.b
Closely supervise pediatric patients receiving paroxetine for any reason and adult patients with major depressive disorder or other psychiatric illness with comorbid depression during initiation of therapy and during periods of dosage adjustments.1 312 314 (See Boxed Warning.) Carefully monitor all patients, particularly young adults and those that are improving, during paroxetine therapy regardless of the condition being treated.b
If anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and/or mania occur, consider changing or discontinuing therapy, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.1 312 314 If decision is made to discontinue therapy, taper paroxetine dosage as rapidly as is feasible but consider risks of abrupt discontinuance.1 312 314 (See General under Dosage and Administration.)
Fetal/Neonatal Morbidity and Mortality
May increase risk of fetal defects (e.g., cardiovascular malformations, principally ventricular and atrial septal defects; other major congenital malformations) when administered to pregnant women.326 333 337 338 a c
If a patient becomes pregnant during treatment, advise patient of the potential hazard to the fetus.337 338 a c Unless the potential benefits to the mother justify continuing treatment, consider discontinuing paroxetine therapy or switching to another antidepressant.337 338 a c For women who intend to become pregnant or are in their first trimester of pregnancy, initiate paroxetine only after consideration of other available treatment options.337 338 a c
Possible complications, sometimes severe and requiring prolonged hospitalization, respiratory support, enteral nutrition, and other forms of supportive care in neonates exposed to paroxetine, other SSRIs, or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs) late in the third trimester; may arise immediately upon delivery.1 312 327 328 329 330 331 332
Carefully consider both the potential risks and benefits of treatment when used during the third trimester of pregnancy.1 312 326 328 329 330 Be aware that in a longitudinal study involving women with a history of major depressive disorder who were euthymic while receiving antidepressant therapy at the beginning of pregnancy, women who discontinued antidepressant therapy during pregnancy were more likely to experience a relapse of depression than those who remained on antidepressant therapy.1 312 Consider cautiously tapering dose during third trimester prior to delivery.1 312 329 330 331 332
Activation of Mania or Hypomania
May occur secondary to SIADH;24 25 28 apparently reversible following discontinuance of the drug and/or fluid restriction.1 22 24 28 210 215 217 Occurs mainly in older patients1 22 24 25 28 and those receiving diuretics or otherwise volume depleted.1 (See Geriatric Use under Cautions.)
Cognitive and Motor Performance
Does not appear to produce substantial cognitive or motor impairment,1 2 3 18 19 24 62 72 73 but patients should be cautioned to avoid activities requiring alertness or physical coordination until effects on individual are known.1 62
Withdrawal of Therapy
Possible withdrawal reactions following abrupt discontinuance or intermittent noncompliance with therapy.1 23 24 32 33 46 47 196 197 198 199 200 201 202 203 204 205 206 Avoid abrupt discontinuance of therapy;24 184 197 198 200 204 taper dosage gradually over a period of several weeks.184 194 197 198 200
Electroconvulsive Therapy (ECT)
Effects of concomitant use with ECT have not been systematically evaluated.1
Greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, obsessive-compulsive disorder, or other psychiatric disorders based on pooled analyses of short-term placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).1 312 314 315 No suicides occurred in these trials.1 312 314 315 If considering use of paroxetine in a child or adolescent, balance potential risks with clinical need.1 311 312 314 315 (See Worsening of Depression and Suicidality Risk under Cautions.)
Possible decreased clearance; however, efficacy and adverse effects similar to those in younger adults.1 2 4 7 18 24 83 95 96 97 Initiate therapy at a lower dosage.1 8 95 (See Geriatric or Debilitated Patients under Dosage and Administration.)
May be more likely than younger patients to develop hyponatremia and transient SIADH.1 22 24 25 28 214 215 Periodically monitor serum sodium concentrations, especially during the first several months of therapy.181 217
Increased plasma concentrations1 4 98 99 and decreased clearance reported.1 137 Use with caution; use at a reduced initial dosage if impairment is severe.1 98 99 145 225 (See Hepatic Impairment under Dosage and Administration.)
Increased plasma concentrations1 4 98 99 and decreased clearance reported.1 137 Use with caution; use at a reduced initial dosage if impairment is severe.1 98 99 145 225 (See Renal Impairment under Dosage and Administration.)
Common Adverse Effects
Nervous system effects (e.g., asthenia, somnolence, dizziness, insomnia, tremor, nervousness), GI effects (e.g., nausea, decreased appetite, constipation, dry mouth), impotence, ejaculatory dysfunction, female genital disorders (e.g., anorgasmia or difficulty reaching climax/orgasm), sweating.1 2 3 24 76
Interactions for Paroxetine Hydrochloride
Drugs Metabolized by Hepatic Microsomal Enzymes
Use with caution and consider reducing dosage of concomitantly administered CYP2D6 substrate, particularly those with a narrow therapeutic index, such as TCAs, class IC antiarrhythmics and some phenothiazines.1 91 277
Drugs Affecting Hepatic Microsomal Enzymes
Inhibitors or inducers of CYP isoenzymes (e.g., CYP2D6): potential pharmacokinetic interaction (altered paroxetine metabolism and plasma concentrations).a
Drugs Associated with Serotonin Syndrome
Potential pharmacodynamic interaction (serotonin syndrome).1 229 230 231 232 233 234 235 Although usually mild, serious complications and death occasionally have been reported.1 230 231 233 236 237 238 239 Serotonin syndrome most commonly occurs when serotonergic agents with different mechanisms of action are given concurrently or in close succession.230 231 233 236 237 Avoid such use, or use with caution.237 239
Drugs Affecting Hemostasis
Avoid concomitant use1
Antiarrhythmic agents, class IC (e.g., encainide, flecainide, propafenone)
Possible inhibition of metabolism by paroxetinea
Antidepressants, tricyclic (TCA)
Increased peak plasma concentrations, AUC, and elimination half-life of TCA1
Use with caution1
May need to monitor plasma tricyclic concentrations; consider reducing tricyclic dosage1
Pharmacokinetics of paroxetine not affected335
Benzodiazepines (e.g., diazepam, lorazepam, oxazepam)
Adjust paroxetine dosage as needed1
Possible increases in plasma clozapine concentrations286
Use with caution and monitor closely
Adjust dosage as needed286
Digoxin AUC reduced by 15%; limited clinical experience to date1
Use with caution1
Pharmacokinetic or pharmacodynamic interactions unlikely1
Use with caution1
MAO inhibitors (e.g., isoniazid, moclobemide, selegiline)
Severe hypotension possible1
NSAIAs (e.g., aspirin)
Possible inhibition of metabolism by paroxetine1
Decreased AUC and elimination half-life of paroxetine1
Adjust dosage as needed1
Decreased AUC and elimination half-life of paroxetine and increased plasma phenytoin concentration1
Adjust dosages as needed1
Increased plasma procyclidine concentrations 1
If anticholinergic effects are seen, decrease procyclidine dosage1
Paroxetine did not affect plasma propranolol concentrations; effects of propranolol on plasma paroxetine concentrations not evaluated1
Potential for displacement of paroxetine or other protein-bound drugs from binding sites1
Monitor patients for potential adverse effects 1
Increased plasma risperidone concentrations, decreased plasma 9-hydroxyrisperidone (active metabolite) concentrations, and increased plasma concentrations of active moiety (risperidone plus 9-hydroxyrisperidone)1 322
Generally well tolerated; possible risk of parkinsonian symptoms322
Carefullly monitor patients; consider monitoring plasma risperidone concentrations322
Consider lower initial dosage of paroxetine (10–20 mg daily)322
Monitor patient 1
Increased serum theophylline concentrations1
Monitor for theophylline toxicity1
Potentially serious or fatal reaction (e.g., torsade de pointes)1
Concomitant use contraindicated1
Adverse effects resembling serotonin syndrome1
Avoid concomitant use1
Use with caution1
Paroxetine Hydrochloride Pharmacokinetics
Completely absorbed following oral administration.1
Oral bioavailability in humans not fully elucidated to date.1
Equally bioavailable from commercially available conventional tablets and suspension.a
In geriatric patients, trough paroxetine concentrations are 70–80% greater than in younger patients.1
In patients with renal impairment (Clcr <30 mL/minute), mean plasma paroxetine concentrations are approximately 4 times greater than those seen in healthy individuals.1
Hepatic impairment may increase plasma concentrations twofold.1
Widely distributed in the body, including the CNS and breast milk.1
Plasma Protein Binding
Mechanism of action as an antidepressant is presumed to be linked to potentiation of serotonergic activity in the CNS resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).1 4 6 84
Has little or no effect on other neurotransmitters1 4 6 84 or any clinically important anticholinergic, antihistaminic, or adrenergic (α1, α2, β) blocking activity at usual therapeutic dosages.1 4 84 85
Advice to Patients
Risk of suicidalility; importance of patients, caregivers, and families immediately reporting emergence of suicidality, worsening depression, or other manifestations associated with increased risk of worsening depression or suicidality.1 312 314 320 FDA recommends providing written patient information (medication guide) explaining risks in pediatric patients each time the drug is dispensed.314 320
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
10 mg (of paroxetine) per 5 mL
Paxil (with parabens, propylene glycol, saccharin sodium, and sorbitol)
Tablets, extended-release, film-coated
12.5 mg (of paroxetine)
25 mg (of paroxetine)
37.5 mg (of paroxetine)
10 mg (of paroxetine)*
20 mg (of paroxetine)*
30 mg (of paroxetine)*
40 mg (of paroxetine)*
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
PARoxetine HCl 10MG Tablets (ZYDUS PHARMACEUTICALS (USA)): 30/$29.99 or 90/$79.97
PARoxetine HCl 12.5MG 24-hr Tablets (MYLAN): 30/$102.67 or 90/$277.32
PARoxetine HCl 20MG Tablets (ZYDUS PHARMACEUTICALS (USA)): 30/$15.99 or 60/$23.97
PARoxetine HCl 25MG 24-hr Tablets (MYLAN): 30/$105.86 or 90/$289.01
PARoxetine HCl 30MG Tablets (MYLAN): 30/$35.99 or 90/$89.97
PARoxetine HCl 37.5MG 24-hr Tablets (APOTEX): 30/$107.99 or 90/$296.44
PARoxetine HCl 40MG Tablets (ZYDUS PHARMACEUTICALS (USA)): 30/$24.99 or 90/$59.95
Paxil 10MG/5ML Suspension (APOTEX): 250/$189.98 or 750/$539.94
Paxil 10MG Tablets (APOTEX): 30/$116.99 or 90/$320.98
Paxil 20MG Tablets (APOTEX): 30/$125.99 or 90/$349.96
Paxil 30MG Tablets (APOTEX): 30/$129.99 or 90/$369.97
Paxil 40MG Tablets (APOTEX): 30/$136.99 or 90/$384.94
Paxil 40MG Tablets (APOTEX): 30/$136.99 or 90/$384.95
Paxil CR 12.5MG 24-hr Tablets (APOTEX): 30/$120.00 or 90/$335.96
Paxil CR 25MG 24-hr Tablets (APOTEX): 30/$139.98 or 90/$383.95
Paxil CR 37.5MG 24-hr Tablets (APOTEX): 30/$141.99 or 90/$411.97
Pexeva 20MG Tablets (NOVEN THERAPEUTICS): 30/$190.98 or 90/$528.95
Pexeva 30MG Tablets (NOVEN THERAPEUTICS): 30/$200.98 or 90/$584.96
Pexeva 40MG Tablets (NOVEN THERAPEUTICS): 30/$205.99 or 90/$572.98
AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions February 1, 2012. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. GlaxoSmithKline Pharmaceuticals. Paxil (paroxetine hydrochloride) tablets and oral suspension prescribing information. 2005 Sep.
2. Ayd FJ. Paroxetine, a new selective serotonin reuptake inhibitor. Int Drug Ther Newsl. 1993; 28:5-12.
3. Dechant KL, Clissold SP. Paroxetine: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in depressive illness. Drugs. 1991; 41:225-53. [PubMed 1709852]
4. Cardoni AA. Focus on paroxetine: a potent, selective serotonin uptake inhibitor for use in major depression. Hosp Formul. 1992; 27:445-63.
5. Boyer WF, Feighner JP. An overview of paroxetine. J Clin Psychiatr. 1992; 53(Suppl 2):3-6.
6. Tulloch IF, Johnson AM. The pharmacologic profile of paroxetine, a new selective serotonin reuptake inhibitor. J Clin Psychiatr. 1992; 53(Suppl 2):7-12.
7. De Vane CL. Pharmacokinetics of the selective serotonin reuptake inhibitors. J Clin Psychiatr. 1992; 53(Suppl 2):13-20.
8. Dunner DL, Dunbar GC. Optimal dose regimen for paroxetine. J Clin Psychiatr. 1992; 53(Suppl 2):21-6.
9. Kiev A. A double-blind, placebo-controlled study of paroxetine in depressed outpatients. J Clin Psychiatr. 1992; 53(Suppl 2):27-9.
10. Rickels K, Amsterdam J, Clary C et al. The efficacy and safety of paroxetine compared with placebo in outpatients with major depression. J Clin Psychiatr. 1992; 53(Suppl 2):30- 2.
11. Claghorn JL. The safety and efficacy of paroxetine compared with placebo in a double- blind trial of depressed outpatients. J Clin Psychiatr. 1992; 53(Suppl 2):33-5.
12. Smith WT, Glaudin V. A placebo-controlled trial of paroxetine in the treatment of major depression. J Clin Psychiatr. 1992; 53(Suppl 2):36-9.
13. Fabre LF. A 6-week, double-blind trial of paroxetine, imipramine, and placebo in depressed outpatients. J Clin Psychiatr. 1992; 53(Suppl 2):40-3.
14. Feighner JP, Boyer WF. Paroxetine in the treatment of depression: a comparison with imipramine and placebo. J Clin Psychiatr. 1992; 53(Suppl 2):44-7.
15. Shrivastava RK, Shrivastava SHP, Overweg N et al. A double-blind comparison of paroxetine, imipramine, and placebo in major depression. J Clin Psychiatr. 1992; 53(Suppl 2):48-51.
16. Cohn JB, Wilcox CS. Paroxetine in major depression: a double-blind trial with imipramine and placebo. J Clin Psychiatr. 1992; 53(Suppl 2):52-6.
17. Claghorn JL, Kiev A, Rickels K et al. Paroxetine versus placebo: a double-blind comparison in depressed patients. J Clin Psychiatr. 1992; 53:434-8.
18. Boyer WF, Blumhardt CL. The safety profile of paroxetine. J Clin Psychiatr. 1992; 53(Suppl 2):61-6.
19. Grimsley SR, Jann MW. Paroxetine, sertraline, and fluvoxamine: new selective serotonin reuptake inhibitors. Clin Pharm. 1992; 11:930-57. [IDIS 303853] [PubMed 1464219]
20. Dunner DL, Cohn JB, Walshe T et al. Two combined, multicenter double-blind studies of paroxetine and doxepin in geriatric patients with major depression. J Clin Psychiatr. 1992; 53(Suppl 2):57-60.
21. Rickels K, Schweizer E. Clinical overview of serotonin reuptake inhibitors. J Clin Psychiatr. 1990; 51(Suppl 12B):9-12.
22. Goddard C, Paton C. Hyponatremia associated with paroxetine. BMJ. 1992; 305:1332. [IDIS 307374] [PubMed 1483080]
23. Lewis J, Braganza J, Williams T. Psychomotor retardation and semistuporous state with paroxetine. BMJ. 1993; 306:1169. [IDIS 313777] [PubMed 8499822]
24. Holliday SM, Plosker GL. Paroxetine. A review of its pharmacology, therapeutic use in depression and therapeutic potential in diabetic neuropathy. Drugs Aging. 1993; 3:278-99. [PubMed 8324301]
25. Chua TP, Vong SK. Hyponatraemia associated with paroxetine. BMJ. 1993; 306:143. [IDIS 308078] [PubMed 8435627]
26. De Wilde J, Spiers R, Mertens C et al. A double-blind, comparative, multicentre study comparing paroxetine with fluoxetine in depressed patients. Acta Psychiatr Scand. 1993; 87:141-5. [IDIS 321555] [PubMed 8447241]
27. Ottervanger JP, Stricker BHC, Huls J et al. Bleeding attributed to the intake of paroxetine. Am J Psychiatr. 1994; 151:781-2. [IDIS 329225] [PubMed 8166328]
28. Chua TP, Vong SK. Paroxetine and hyponatraemia. Br J Clin Pract. 1994; 48:49. [IDIS 325386] [PubMed 8179984]
29. Dunbar GC. An interim overview of the safety and tolerability of paroxetine. Acta Psychiatr Scand. 1989; 80(Suppl 350):135-7.
30. Ohrberg S, Christiansen PE, Severin B et al. Paroxetine and imipramine in the treatment of depressive patients in psychiatric practice. Acta Psychiatr Scand. 1992; 86:437-44. [PubMed 1471536]
31. Dunbar GC, Cohn JB, Fabre LF et al. A comparison of paroxetine, imipramine and placebo in depressed out-patients. Br J Psychiatr. 1991; 159:394-8.
32. Barr LC, Goodman WK, Price LW. Physical symptoms associated with paroxetine discontinuation. Am J Psychiatr. 1994; 151:289. [IDIS 325219] [PubMed 8296907]
33. Choo V. Paroxetine and extrapyramidal reactions. Lancet. 1993; 341:624. [PubMed 8094844]
34. Edwards JG, Goldie A, Papayanni-Papasthatis S et al. Effect of paroxetine on the electrocardiogram. Psychopharmacology. 1989; 97:96-8. [PubMed 2523548]
35. Baldwin D, Fineberg N, Montgomery S. Fluoxetine, fluvoxamine, and extrapyramidal tract disorders. Int Clin Psychopharmacol. 1991; 6:51-8. [PubMed 1906498]
36. Committee on Safety of Drugs. Curr Prob Pharmacovigilance. 1993; 19:1.
37. Pfizer. Zoloft (sertraline hydrochloride) tablets and oral concentrate prescribing information. New York; 2000 Jan.
38. Kuhs H, Rudolf GA. Cardiovascular effects of paroxetine. Psychopharmacology (Berl). 1990; 102:379-82. [PubMed 2147517]
39. Anon. Drugs for psychiatric disorders. Med Lett Drugs Ther. 1994; 36:89-96. [PubMed 7935156]
40. Barrett J. Anisocoria associated with selective serotonin reuptake inhibitors. BMJ. 1994; 309:1620. [IDIS 340042] [PubMed 7819940]
41. Markel H, Lee A, Holmes RD et al. LSD flashback syndrome exacerbated by selective serotonin reuptake inhibitor antidepressants in adolescents. J Pediatr. 1994; 125:817-9. [IDIS 337830] [PubMed 7965440]
42. American Psychiatric Association. Practice guideline for the treatment of patients with major depressive disorder (revision). Am J Psychiatry. 2000; 157(Suppl 4):1-45.
44. Wolkenstein P, Cremniter D, Roujeau JC. Toxic epidermal necrolysis after paroxetine treatment. Eur Psychiatr. 1995; 10:162.
45. Ahmad S. Paroxetine-induced priapism. Arch Intern Med. 1995; 155:645. [IDIS 344448] [PubMed 7887764]
46. Keutehn NJ, Cyr P, Ricciardi RA et al. Medication withdrawal symptoms in obsessive- compulsive disorder patients treated with paroxetine. J Clin Psychopharmacol. 1994; 14:206-7. [IDIS 329866] [PubMed 8027419]
47. Bloch M, Stager SV, Braun AR et al. Severe psychiatric symptoms associated with paroxetine withdrawal. Lancet. 1995; 346:57. [PubMed 7603169]
48. Oehrberg S, Christiansen PE, Behnke K et al. Paroxetine in the treatment of panic disorder: a randomised, double-blind, placebo-controlled study. Br J Psychiatry. 1995; 167:374-9. [IDIS 355124] [PubMed 7496647]
49. American Psychiatric Association. Diagnostic and statistical manual of mental disorders: DSM-IV™. 4th ed. Washington, DC: American Psychiatric Association; 1994:393- 444.
50. Reviewers’ comments (personal observations) on clomipramine hydrochloride 28:16.04.
51. Montgomery SA. Long-term managment of obsessive-compulsive disorder. Int Clin Psychopharmacol. 1996; 11(Suppl. 5):23-9. [PubMed 9032001]
52. Greist JH, Jefferson JW, Kobak KA et al. A 1 year double-blind placebo controlled fixed dose study of sertraline in the treatment of obsessive-compulsive disorder. Int Clin Psychopharmacol. 1995; 10:57-65. [PubMed 7673657]
53. Ballenger JC, Wheadon DE, Steiner M et al. Double-blind, fixed-dose, placebo- controlled study of paroxetine in the treatment of panic disorder. Am J Psychiatry. 1998; 155:36-42. [IDIS 399512] [PubMed 9433336]
54. Lecrubier Y, Judge R for Collaborative Paroxetine Panic Study Investigators. Long- term evaluation of paroxetine, clomipramine and placebo in panic disorder. Acta Psychiatr Scand. 1997; 95:153-60. [PubMed 9065681]
55. Pigott TA. OCD: where the serotonin selectivity story begins. J Clin Psychiatr. 1996; 57(Suppl. 6):11-20.
56. Sharpley AL, Williamson DJ, Attenburrow ME et al. The effects of paroxetine and nefazodone on sleep: a placebo controlled trial. Psychopharmacology (Berl). 1996; 126:50-4. [PubMed 8853216]
57. Staner L, Kerkhofs M, Detroux D et al. Acute, subchronic and withdrawal sleep EEG changes during treatment with paroxetine and amitriptyline: a double-blind randomized trial in major depression. Sleep. 1995; 18:470-7. [PubMed 7481419]
58. Saletu B, Frey R, Krupka M et al. Sleep laboratory studies on the single-dose effects of serotonin reuptake inhibitors paroxetine and fluoxetine on human sleep and awakening qualities. Sleep. 1991; 14:439-47. [PubMed 1836894]
59. Oswald I, Adam K. Effects of paroxetine on human sleep. Br J Clin Pharmacol. 1986; 22:97-99. [IDIS 219707] [PubMed 2943309]
60. Kupfer DJ, Spiker DG, Coble PA et al. Sleep and treatment prediction in endogenous depression. Am J Psychiatry. 1981; 138:429-34. [IDIS 176783] [PubMed 7212100]
61. Vogel GW, Vogel F, McAbee RS et al. Improvement of depression by REM sleep deprivation: new findings and a theory. Arch Gen Psychiatry. 1980; 37:247-53. [PubMed 7362414]
62. Robbe HWJ, O Hanlon JF. Acute and subchronic effects of paroxetine 20 and 40 mg on actual driving, psychomotor performance and subjective assessments in healthy volunteers. Eur Neuropsychopharmacol. 1995; 5:35-42. [PubMed 7613099]
63. Leonard BE. Pharmacological differences of serotonin reuptake inhibitors and possible clinical relevance. Drugs. 1992; 43(Suppl. 2):3-10. [PubMed 1378371]
64. Sanders-Bush E, Breeding M, Knoth K et al. Sertraline-induced desensitization of the serotonin 5HT-2m receptor transmembrane signaling system. Psychopharmacol (Berlin). 1989; 99:1:64-9.
65. Heym J, Koe BK. Pharmacology of sertraline. J Clin Psychiatr. 1988; 49(Suppl.):40-45.
66. Fuller RW. Serotonin uptake inhibitors: uses in clinical therapy and in laboratory research. Prog Drug Res. 1995; 45:167-204. [PubMed 8545537]
67. Garattini S. An update on the pharmacology of serotoninergic appetite-suppressive drugs. Int J Obes Relat Metab Disord. 1992; 16(Suppl. 4):S41-8.
68. Simansky KJ. Serotonergic control of the organization of feeding and satiety. Behav Brain Res. 1996; 73:1-2,37-42. [PubMed 8788468]
69. Doogan DP, Caillard V. Sertraline: a new antidepressant. J Clin Psychiatry. 1988; 49(Suppl.):46-51. [IDIS 246663] [PubMed 2842321]
70. Myers RD, Quarfordt SD. Alcohol drinking attenuated by sertraline in rats with 6- OHDA or 5,7-DHT lesions of N. accumbens: a caloric response. Pharmacol Biochem Behav. 1991; 40:923-8. [PubMed 1816578]
71. Gill K, Amit Z, Koe BK. Treatment with sertraline, a new serotonin uptake inhibitor, reduces voluntary ethanol consumption in rats. Alcohol. 1988; 5:349-54. [PubMed 3219181]
72. Kerr JS, Fairweather DB, Mahendran R et al. The effects of paroxetine, alone and in combination with alcohol on psychomotor performance and cognitive function in the elderly. Int Clin Psychopharmacol. 1992; 7:101-8. [PubMed 1487621]
73. Hindmarch I. A review of the psychomotor effects of paroxetine. Int Clin Psychopharmacol. 1992; 6(Suppl. 4):65-7. [PubMed 1431014]
74. Kiev A, Feiger A. A double-blind comparison of fluvoxamine and paroxetine in the treatment of depressed outpatients. J Clin Psychiatry. 1997; 58:146-52. [IDIS 386410] [PubMed 9164424]
75. Brown WA, Harrison W. Are patients who are intolerant to one SSRI intolerant to another? Psychopharmacol Bull. 1992; 28:253-256.
76. Dunbar GC, Claghorn JL, Kiev A et al. A comparison of paroxetine and placebo in depressed outpatients. Acta Psychiatr Scand. 1993; 87:302-5. [PubMed 8517168]
77. Montgomery SA. The advantages of paroxetine in different subgroups of depression. Int Clin Psychopharmacol. 1992; 6(Suppl. 4):91-100. [PubMed 1431017]
78. McClelland GR, Raptopoulos P. EEG and blood level of the potential antidepressant paroxetine after a single oral dose to normal volunteers. Psychopharmacology (Berl). 1984; 83:327-329. [PubMed 6238338]
79. Sundblad C, Wikander I, Andersch B et al. A naturalistic study of paroxetine in premenstrual syndrome: efficacy and side-effects during ten cycles of treatment. Eur Neuropsychopharmacol. 1997; 7:201-6. [PubMed 9213079]
80. Eriksson E, Hedberg MA, Andersch B et al. The serotonin reuptake inhibitor paroxetin is superior to the noradrenaline reuptake inhibitor maprotiline in the treatment of premenstrual syndrome. Neuropsychopharmacol. 1995; 12:167-76.
81. Anon. Paroxetine for treatment of depression. Med Lett Drugs Ther. 1993; :24-26. [PubMed 8441363]
82. DeVane CL. Pharmacokinetics of the selective serotonin reuptake inhibitors. J Clin Psychiatry. 1992; 53(Suppl. 2):13-20. [IDIS 292903] [PubMed 1531816]
83. Kaye CM, Haddock RE, Langley PF et al. A review of the metabolism and pharmacokinetics of paroxetine in man. Acta Psychiatr Scand. 1989; 80(Suppl. 350):60- 75. [PubMed 2763860]
84. Johnson AM. An overview of the animal pharmacology of paroxetine. Acta Psychiatr Scand. 1989; 80(Suppl. 350):14-20.
85. Thomas DR, Nelson DR, Johnson AM. Biochemical effects of the antidepressant paroxetine, a specific 5-hydroxytryptamine uptake inhibitor. Psychopharmacology. 1987; 93:193-200. [PubMed 2962217]
86. Kleinlogel H, Burki H. Effects of selective 5-hydroxytryptamine uptake inhibitors, paroxetine and zimeldine, on EEG sleep and waking changes in the rat. Neuropsychobiology. 1987; 17:206-12. [PubMed 2964564]
87. Watanabe S, Ohta H, Ohno M et al. Electroencephalographic effects of the new antidepressant paroxetine in the rabbit. Arzneimittelforschung. 1988; 38:332-340. [PubMed 2968081]
88. Nemeroff CB. The clinical pharmacology and use of paroxetine, a new selective serotonin reuptake inhibitor. Pharmacotherapy. 1994; 14:127-38. [IDIS 327374] [PubMed 8197030]
89. Tulloch IF, Johnson AM. The pharmacologic profile of paroxetine, a new selective serotonin reuptake inhibitor. J Clin Psychiatry. 1992; 53(2 Suppl.):7-12. [IDIS 292902] [PubMed 1531829]
90. Garattini S. Biological actions of drugs affecting serotonin and eating. Obesity Res. 1995; 3(Suppl. 4):463-470S.
91. Preskorn SH. Clinically relevant pharmacology of selective serotonin reuptake inhibitors: an overview with emphasis on pharmacokinetics and effects on oxidative drug metabolism. Clin Pharmacokinet. 1997; 32(Suppl. 1):1-21. [PubMed 9068931]
92. Greb WH, Brett MA, Buscher G et al. Absorption of paroxetine under various dietary conditions and following antacid intake. Acta Psychiatrica Scand. 1989; 80(Suppl. 350):99-101.
93. Tasker TCG, Kaye CM, Zussman BD et al. Paroxetine plasma levels: lack of correlation with efficacy or adverse events. Acta Psychiatrica Scand. 1989; 80(Suppl. 350):152-155.
94. Haddock RE, Johnson AM, Langley PF et al. Metabolic pathway of paroxetine in animals and man and the comparative pharmacological properties of its metabolites. Acta Psychiatrica Scand. 1989; 80(Suppl. 350):24-26.
95. Bayer AJ, Roberts NA, Allen EA et al. The pharmacokinetics of paroxetine in the elderly. Acta Psychiatrica Scand. 1989; 80(Suppl. 350):85-6.
96. Lundmark J, Scheel Thomsen I, Fjord-Larsen T et al. Paroxetine: pharmacokinetic and antidepressant effect in the elderly. Acta Psychiatrica Scand. 1989; 80(Suppl. 350):76-80.
97. Ghose K. The pharmacokinetics of paroxetine in elderly depressed patients. Acta Psychiatrica Scand. 1989; 80(Suppl. 350):87-88.
98. Krastsev Z, Terziivanov D, Vlahov V et al. The pharmacokinetics of paroxetine in patients with liver cirrhosis. Acta Psychiatrica Scand. 1989; 80(Suppl. 350):91-2.
99. Doyle GD, Laher M, Kelly JG et al. The pharmacokinetics of paroxetine in renal impairment. Acta Psychiatrica Scand. 1989; 80(Suppl. 350):89-90.
100. Spigset O, Carleborg L, Norstrom A et al. Paroxetine level in breast milk. J Clin Psychiatry. 1996; 57:39. [IDIS 360768] [PubMed 8543546]
101. Montgomery SA. Efficacy in long-term treatment of depression. J Clin Psychiatry. 1996; 57(Suppl. 2):24-30. [IDIS 367836] [PubMed 8626360]
102. Tucker GJ. Psychiatric disorders in medical practice. In: Wyngaarden JB, Smith LH Jr, Bennett JC. Cecil textbook of medicine. 19th ed. Philadelphia; 1992:2079-90.
103. Montgomery SA, Doogan DP, Burnside R. The influence of different relapse criteria on the assessment of long-term efficacy of sertraline. Int Clin Psychopharmacol. 1991; 6(Suppl. 2):37-46. [PubMed 1806629]
104. Franchini L, Gasperini M, Perez J et al. A double-blind study of long-term treatment with sertraline or fluvoxamine for prevention of highly recurrent unipolar depression. J Clin Psychiatry. 1997; 58:104-7. [IDIS 384090] [PubMed 9108811]
105. Leonard BE. The comparative pharmacology of new antidepressants. J Clin Psychiatry. 1993; 54(Suppl):3-15. [IDIS 320053] [PubMed 8253704]
106. Wernicke JF. The side effect profile and safety of fluoxetine. J Clin Psychiatry. 1985; 46:59-67. [IDIS 197277] [PubMed 3156126]
107. Settle EC Jr, Puzzuoli Settle G. A case of mania associated with fluoxetine. Am J Psychiatry. 1984; 141:280-1. [IDIS 180957] [PubMed 6362443]
108. Bunney WE Jr, Goodwin FK, Murphy DL et al. The “switch process” in manic- depressive illness. II. Relationship to catecholamines, REM sleep, and drugs. Arch Gen Psychiatry. 1974; 27:304-9.
109. Lebegue B. Mania precipitated by fluoxetine. Am J Psychiatry. 1987; 144:1620. [IDIS 237173] [PubMed 3500651]
110. Turner SM, Jacob RG, Beidel DC et al. A second case of mania associated with fluoxetine. Am J Psychiatry. 1985; 142:274-5. [IDIS 195897] [PubMed 3871593]
111. Peet M. Induction of mania with selective serotonin re-uptake inhibitors and tricyclic antidepressants. Br J Psychiatry. 1994; 164:549-50. [IDIS 328227] [PubMed 8038948]
112. Rickels K, Amsterdam J, Clary C et al. A placebo-controlled, double-blind, clinical trial of paroxetine in depressed outpatients. Acta Psychiatr Scand. 1989; 80(Suppl. 350):117-123.
113. Miller SM, Naylor GJ, Murtagh M et al. A double-blind comparison of paroxetine and placebo in the treatment of depressed outpatients in a psychiatric outpatient clinic. Acta Psychiatr Scand. 1989; 80(Suppl. 350):143-4.
114. Battegay R, Hager M, Rauschfleisch U. Double-blind comparative study of paroxetine and amitriptyline in depressed patients of a university psychiatric outpatient clinic (pilot study). Neuropsychobiology. 1985; 13:31-7. [PubMed 3162108]
115. Laursen AL, Mikkelsen PL, Rasmussen S et al. Paroxetine in the treatment of depression: a randomized comparison with amitriptyline. Acta Psychiatr Scand. 1985; 71:249-55. [PubMed 3157296]
116. Gagiano CA, Muller PGM, Fourie J et al. The therapeutic efficacy of paroxetine: (a) an open study in patients with major depression not responding to antidepressants; (b) a double- blind comparison with amitriptyline in depressed outpatients. Acta Psychiatr Scand. 1989; 80(Suppl. 350):130-1.
117. Kuhs H, Rudolf GAE. A double-blind study of the comparative antidepressant effect of paroxetine and amitriptyline. Acta Psychiatr Scand. 1989; 80(Suppl. 350):145-6.
118. Bascara L. A double-blind study to compare the effectiveness and tolerability of paroxetine and amitriptyline in depressed patients. Acta Psychiatr Scand. 1989; 80(Suppl. 350):141-2.
119. Feighner JP, Boyer WF. Paroxetine in the treatment of depression: a comparison with imipramine and placebo. Acta Psychiatr Scand. 1989; 80(Suppl. 350):125-9. [PubMed 2801160]
120. Ravindran AV, Judge R, Hunter BN et al. A double-blind, multicenter study in primary care comparing paroxetine and clomipramine in patients with depression and associated anxiety: Paroxetine Study Group. J Clin Psychiatry. 1997; 58:112-8. [IDIS 384092] [PubMed 9108813]
121. Christiansen PE, Behnke K, Black CH et al. Paroxetine and amitriptyline in the treatment of depression in general practice. Acta Psychiatr Scand. 1996; 93:158-63. [PubMed 8739658]
122. Baldwin DS, Hawley CJ, Abed RT et al. A multicenter double-blind comparison of nefazodone and paroxetine in the treatment of outpatients with moderate-to-severe depression. J Clin Psychiatry. 1996; 57(Suppl. 2):46-52. [IDIS 367839] [PubMed 8626363]
123. Joffe RT, Levitt AJ, Sokolov ST et al. Response to an open trial of a second SSRI in major depression. J Clin Psychiatry. 1997; 58:326-7. [IDIS 390955] [PubMed 9269258]
124. Lapierre Y, Bentkover J, Schainbaum S et al. Direct cost of depression: analysis of treatment costs of paroxetine versus imipramine in Canada. Can J Psychiatry. 1995; 40:370-7. [PubMed 8548716]
125. Rechlin T. The effect of amitriptyline, doxepin, fluvoxamine, and paroxetine treatment on heart rate variability. J Clin Psychopharmacol. 1994; 14:392-5. [IDIS 340020] [PubMed 7884019]
126. Stuppaeck CH, Geretsegger C, Whitworth AB et al. A multicenter double-blind trial of paroxetine versus amitriptyline in depressed inpatients. J Clin Psychopharmacol. 1994; 14:241-6. [IDIS 332996] [PubMed 7962679]
127. Rechlin T, Weis M, Claus D. Heart rate variability in depressed patients and differential effects of paroxetine and amitriptyline on cardiovascular autonomic functions. Pharmacopsychiatry. 1994; 27:124-8. [PubMed 8078953]
128. Geretsegger C, Bohmer F, Ludwig M. Paroxetine in the elderly depressed patients: randomized comparison with fluoxetine of efficacy, cognitive and behavioural effects. Int Clin Psychopharmacol. 1994; 9:25-9. [PubMed 8195578]
129. Duboff EA. Long-term treatment of major depressive disorder with paroxetine. J Clin Psychopharmacol. 1993; 13(6 Suppl. 2):28S-33S. [IDIS 323205] [PubMed 8106653]
130. Claghorn JL, Feighner JP. A double-blind comparison of paroxetine with imipramine in the long-term treatment of depression. J Clin Psychopharmacol. 1993; 13(6 Suppl. 2):23S-27S. [IDIS 323204] [PubMed 8106652]
131. Tignol J. A double-blind, randomized, fluoxetine-controlled, multicenter study of paroxetine in the treatment of depression. J Clin Psychopharmacol. 1993; 13(6 Suppl. 2):18S-22S. [IDIS 323203] [PubMed 8106650]
132. Pelicier Y, Schaeffer P. Multicenter double-blind study comparing the efficacy and tolerance of paroxetine and clomipramine in reactive depression in the elderly patients. Encephale. 1993; 19:257-61. [PubMed 8275912]
133. Montgomery SA, Dunbar G. Paroxetine is better than placebo in relapse prevention and the prophylaxis of recurrent depression. Int Clin Psychopharmacol. 1993; 8:189-95. [PubMed 8263317]
134. Hutchinson DR, Tong S, Moon CA et al. Paroxetine in the treatment of elderly depressed patients in general practice: a double-blind comparison with amitriptyline. Int Clin Psychopharmacol. 1992; 6(Suppl. 4):43-51. [PubMed 1431010]
135. Bignamini A, Rapisarda V. A double-blind multicentre study of paroxetine and amitriptyline in depressed outpatients: Italian Paroxetine Study Group. Int Clin Psychopharmacol. 1992; 6(Suppl. 4):37-41. [PubMed 1431009]
136. Sindrup GH, Gram LF, Brosen K et al. The selective serotonin reuptake inhibitor paroxetine is effective in the treatment of diabetic neuropathy. Pain. 1990; 42:135-44. [PubMed 2147235]
137. Burrows GD, McIntyre IM, Judd FK et al. Clinical effects of serotonin reuptake inhibitors in the treatment of depressive illness. J Clin Psychiatry. 1988; 49(Suppl.):18- 22. [IDIS 246660] [PubMed 3045107]
138. Katona CL, Hunter BN, Bray J. A double-blind comparison of the efficacy and safety of paroxetine and imipramine in the treatment of depression with dementia. Int J Geriatr Psychiatry. 1998; 13:100-8. [PubMed 9526179]
139. Small GW, Rabins PV, Barry PB et al. Diagnosis and treatment of Alzheimer disease and related disorders: consensus statement of the American Association for Geriatric Psychiatry, the Alzheimer’s Association, and the American Geriatrics Society. JAMA. 1997; 278:1363-1371. [IDIS 393115] [PubMed 9343469]
140. American Psychiatric Association. Practice guideline for the treatment of patients with Alzheimer’s disease and other dementias of late life. Am J Psychiatry. 1997; 154(Suppl.):1-39.
141. Zygmont M, Prigerson HG, Houck PR et al. A post hoc comparison of paroxetine and nortriptyline for symptoms of traumatic grief. J Clin Psychiatry. 1998; 59:241-5. [IDIS 407722] [PubMed 9632035]
142. Franchini L, Gasperini M, Perez J et al. Dose-response of paroxetine in preventing depressive recurrences: a randomized, double-blind study. J Clin Psychiatry. 1998; 59:229-32. [IDIS 407719] [PubMed 9632032]
143. Liu B, Anderson G, Mittmann N et al. Use of selective serotonin-reuptake inhibitors or tricyclic antidepressants and risk of hip fractures in elderly people. Lancet. 1998; 351:1303-7. [IDIS 406796] [PubMed 9643791]
144. Edwards JG. Long term pharmacotherapy of depression: can reduce relapses and recurrences in major depression. BMJ. 1998; 316:1180-1. [IDIS 406736] [PubMed 9552990]
145. Roose SP, Laghrissi-Thode F, Kennedy JS et al. Comparison of paroxetine and nortriptyline in depressed patients with ischemic heart disease. JAMA. 1998; 279:187-91. [PubMed 9438725]
146. McClelland GR, Raptopoulos P. Psychomotor effects of paroxetine and amitriptyline, alone and in combination with alcohol. Br J Clin Pharmacol. 1985; 19:578P.
147. Bannister SJ, Houser VP, Hulse JD et al. Evaluation of the potential for interactions of paroxetine with diazepam, cimetidine, warfarin, and digoxin. Acta Psychiatr Scand. 1989; 80(Suppl. 350):102-106.
148. McClelland GR, Loudon JM, Raptopoulos P. Paroxetine and oxazepam: effects on psychomotor performance. Br J Clin Pharmacol. 1987; 23:117P.
149. Stellamans G. A study to investigate the efficacy, adverse events, safety and pharmacodynamic effects of co-administration of paroxetine and lithium. Biol Psychiatry. 1991; 29:628S.
150. Borup C, Meidahl B, Petersen IM et al. An early phase II evaluation of paroxetine, a new potent and selective 5-HT uptake inhibitor in patients with depressive illness. Pharmacopsychiatrica. 1982; 183-186.
151. Ferrando SJ, Goldman JD, Charness WE. Selective serotonin reuptake inhibitor treatment of depression in symptomatic HIV infection and AIDS: improvements in affective and somatic symptoms. Gen Hosp Psychiatry. 1997; 19:89-97. [PubMed 9097063]
152. Elliott AJ, Uldall KK, Bergan K et al. Randomized, placebo-controlled trial of paroxetine versus imipramine in depressed HIV-positive outpatients. Am J Psychiatry. 1998; 155:367-72. [IDIS 402467] [PubMed 9501747]
153. Grassi B, Gambini O, Garghentini G et al. Efficacy of paroxetine for the treatment of depression in the context of HIV infection. Pharmacopsychiatry. 1997; 183-186.
154. Verkes RJ, Van der Mast RC, Hengeveld MW et al. Reduction by paroxetine of suicidal behavior in patients with repeated suicide attempts but not major depression. Am J Psychiatry. 1998; 155:543-7. [IDIS 404512] [PubMed 9546002]
155. Gunasekara NS, Noble S, Benfield P. Paroxetine: an update of its pharmacology and therapeutic use in depression and a review of its use in other disorders. Drugs. 1998; 55:85-120. [PubMed 9463792]
156. Sanders-Bush E, Mayer SE. 5-Hydroxytryptamine (serotonin) receptor agonists and antagonists. In: Hardman JG, Limbird LE, Molinoff PB et al, eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 9th ed. New York: McGraw-Hill; 1996:249-63.
157. Reviewers’ comments (personal observations) on fluoxetine hydrochloride 28:16.04.
158. Ringold AL. Paroxetine efficacy in social phobia. J Clin Psychiatry. 1994; 55:363-4. [IDIS 335646] [PubMed 8071308]
159. Mancini C, Ameringen MV. Paroxetine in social phobia. J Clin Psychiatry. 1996; 57:519-22. [IDIS 377637] [PubMed 8968300]
160. Stein MB, Chartier MJ, Hazen AL et al. Paroxetine in the treatment of generalized social phobia: open-label treatment and double-blind placebo-controlled discontinuation. J Clin Psychopharmacol. 1996; 16:218-22. [IDIS 367780] [PubMed 8784653]
161. Stein MB, Liebowitz MR, Lydiard RB et al. Paroxetine treatment of generalized social phobia (social anxiety disorder): a randomized controlled trial. JAMA. 1998; 280:708-13. [IDIS 410662] [PubMed 9728642]
162. Yonkers KA, Gullion C, Willliams A et al. Paroxetine as a treatment for premenstrual dysphoric disorder. J Clin Psychopharmacol. 1996; 16:3-8. [IDIS 362976] [PubMed 8834412]
163. Langemark M, Olesen J. Sulpiride and paroxetine in the treatment of chronic tension-type headache. An explanatory double-blind trial. Headache. 1994; 34:20-4. [PubMed 8132436]
164. Foster CA, Bafaloukos J. Paroxetine in the treatment of chronic daily headache. Headache. 1994; 10:587-9.
165. Cooper TA, Valcour VG, Gibbons RB et al. Spontaneous ecchymoses due to paroxetine administration. Am J Med. 1998; 104:197-8. [IDIS 404856] [PubMed 9528740]
166. Tielens JA. Vitamin C for paroxetine- and fluvoxamine-associated bleeding. Am J Psychiatry. 1997; 154:883-4. [IDIS 386903] [PubMed 9167526]
167. Alderman CP, Seshadri P, Ben Tovim DI. Effects of serotonin reuptake inhibitors on hemostasis. Ann Pharmacother. 1996; 30:1232-4. [IDIS 375311] [PubMed 8913401]
168. Marshall RD, Schneier FR, Fallon et al. An open trial of paroxetine in patients with noncombat-related, chronic posttraumatic stress disorder. J Clin Psychopharmacol. 1998; 18:10-8. [IDIS 399924] [PubMed 9472837]
169. Waldinger MD, Hengeveld MW, Zwinderman AH. Paroxetine treatment of premature ejaculation: a double-blind, randomized, placebo-controlled study. Am J Psychiatry. 1994; 151:1377-9. [IDIS 334961] [PubMed 8067497]
170. Isaksen PM. The effect of an antidepressive agent on premature ejaculation. Tidsskr Nor Laegeforen. 1995; 115:1616-7. [PubMed 7778076]
171. Ludovico GM, Corvasce A, Pagliarulo G et al. Paroxetine in the treatment of premature ejaculation. Br J Urol. 1996; 77:881-2. [PubMed 8705226]
172. Waldinger MD, Hengeveld MW, Zwinderman AH. Ejaculation-retarding properties of paroxetine in patients with primary premature ejaculation: a double-blind, randomized, dose- response study. Br J Urol. 1997; 79:592-5. [PubMed 9126089]
173. Giammusso B, Morgia G, Spampinato A et al. Paroxetine in the treatment of premature ejaculation. Arch Ital Urol Androl. 1997; 69:11-3. [PubMed 9181900]
174. Balon R. Antidepressants in the treatment of premature ejaculation. J Sex Marital Ther. 1996; 22:85-96. [PubMed 8743620]
175. Chouinard G. Sertraline in the treatment of obsessive compulsive disorder: two double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 1992; 7(Suppl. 2):37-41. [PubMed 1484177]
176. Greist JH, Jefferson JW, Kobak KA et al. Efficacy and tolerability of serotonin transport inhibitors in obsessive-compulsive disorder: a meta-analysis. Arch Gen Psychiatry. 1995; 52:53-60. [IDIS 341152] [PubMed 7811162]
177. Carpenter LL, McDougle CJ, Epperson CN et al. A risk-benefit assessment of drugs used in the management of obsessive-compulsive disorder. Drug Saf. 1996; 15:116-34. [PubMed 8884163]
178. Harris MG, Benfield P. Fluoxetine: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in older patients with depressive illness. Drugs Aging. 1995; 6:64-84. [PubMed 7696780]
179. Thapa PB, Gideon P, Cost TW et al. Antidepressants and the risk of falls among nursing home residents. New Engl J Med. 1998; 339:875-82. [IDIS 411481] [PubMed 9744971]
180. Sheehan DV, Harnett-Sheehan K. The role of SSRIs in panic disorder. J Clin Psychiatry. 1996; 57(Suppl.10):51-8; discussion 59-60. [IDIS 377784] [PubMed 8917132]
181. Reviewers’ comments (personal observations) on sertraline hydrochloride 28:16.04.
182. Sheehan D, Dunbar GC, Fuell DL. The effect of paroxetine on anxiety and agitation associated with depression. Psychopharmacol Bull. 1992; 28:139-43. [PubMed 1387484]
183. Dunbar GC, Fuell DL. The anti-anxiety and anti-agitation effects of paroxetine in depressed patients. Int Clin Psychopharmacol. 1992; 6(Suppl. 4):81-90. [PubMed 1431016]
184. Davidson JR. The long-term treatment of panic disorder. J Clin Psychiatry. 1998; 59(Suppl. 8):17-21; discussion: 22-3. [IDIS 408262] [PubMed 9707158]
185. Baldwin DS, Birttwwistle J. The side effect burden associated with drug treatment of panic disorder. J Clin Psychiatry. 1998; 59(Suppl. 8):39-44; discussion: 45-6.
186. Gorman JM. The use of newer antidepressants for panic disorder. J Clin Psychiatry. 1997; 58(Suppl. 14):54-8; discussion 59. [IDIS 398618] [PubMed 9418747]
187. Lecrubier Y, Bakker A, Dunbar G et al. A comparison of paroxetine, clomipramine and placebo in the treatment of panic disorder: Collaborative Paroxetine Panic Study Investigators. Acta Psychiatr Scand. 1997; 95:145-52. [PubMed 9065680]
188. Tucker P, Adamson P, Miranda R Jr et al. Paroxetine increases heart rate variability in panic disorder. J Clin Psychopharmacol. 1997; 17:370-6. [IDIS 393805] [PubMed 9315988]
189. Westenberg HG. Developments in the drug treatment of panic disorder: what is the place of the selective serotonin reuptake inhibitors? J Affect Dis. 1996; 40:85-93.
190. deh Boer JA. Pharmacotherapy of panic disorder: differential efficacy from a clinical standpoint. J Clin Psychiatry. 1998; 59:30-6; discussion 37-8.
191. Treatment of panic disorder. NIH Consensus Statement Online 1991 Sep 25-27; 9(2):1- 24.
192. Burnham DB, Steiner MX, Gergel IP et al. Paroxetine long-term safety and efficacy in panic disorder and prevention of relapse: a double-blind study. Paper presented at the 34th Annual Meeting of the American College of Neuropsychopharmacology, 1995.
193. Louie AK, Lannon RA, Ajari LT. Withdrawal reaction after sertraline discontinuation. Am J Psychiatry. 1994;151:450-1. Letter.
194. Lazowick AL, Levin GM. Potential withdrawal syndrome associated with SSRI discontinuation. Ann Pharmacother. 1995; 29:1284-5. [IDIS 357519] [PubMed 8672834]
195. Frost L, Lal S. Shock-like sensations after discontinuance of SSRIs. Am J Psychiatry. 1995; 152:810. [IDIS 346934] [PubMed 7726327]
196. Price JS, Waller PC, Wood SM. A comparison of the post-marketing safety of four selective serotonin re-uptake inhibitors including the investigation of symptoms upon withdrawal. Br J Clin Pharmacol. 1996; 42:757-63. [IDIS 378467] [PubMed 8971432]
197. Rosenbaum JF, Fava M, Hoog SL et al. Selective serotonin reuptake inhibitor discontinuation syndrome: a randomized clinical trial. Biol Psychiatry. 1998; 44:77-87. [PubMed 9646889]
198. Bryois C, Rubin C, Zbinden JD et al. Syndrome de sevrage aux inhibiteurs selectifs de la recapture de la serotonine: a propos d un cas. Schweiz Rundsch Med Prax. 1998; 97:345-8.
199. Stahl MM, Lindquist M, Pettersson M et al. Withdrawal reactions with selective serotonin re-uptake inhibitors as reported to the WHO system. Eur J Clin Pharmacol. 1997; 53:163-9. [IDIS 400068] [PubMed 9476026]
200. Zajecka J, Tracy KA, Mitchell S. Discontinuation symptoms after treatment with serotonin reuptake inhibitors: a literature review. J Clin Psychiatry. 1997; 58:291-7. [IDIS 390945] [PubMed 9269249]
201. Blayac JP, Hillaire Buys D, Peyriere H et al. La pharmacovigilance des nouveaux antidepresseurs: evaluation des troubles neuro-psychocomportementaux. Therapie. 1997; 52:117-22. [PubMed 9231505]
202. Rosenbaum JF, Zajecka J. Clinical management of antidepressant discontinuation. J Clin Psychiatry. 1997; 58(Suppl. 7):37-40. [IDIS 389596] [PubMed 9219493]
203. Schatzberg AF, Haddad P, Kaplan EM et al. Possible biological mechanisms of the serotonin reuptake inhibitor discontinuation syndrome: Discontinuation Consensus Panel. J Clin Psychiatry. 1997; 58(Suppl. 7):23-7. [IDIS 389593] [PubMed 9219490]
204. Lejoyeux M, Ades J. Antidepressant discontinuation: a review of the literature. J Clin Psychiatry. 1997; 58(Suppl. 7):11-5, discussion 16. [IDIS 389591] [PubMed 9219488]
205. Landry P, Roy L. Withdrawal hypomania associated with paroxetine. J Clin Psychopharmacol. 1997; 17:60-1. [IDIS 378305] [PubMed 9004064]
206. Coupland NJ, Bell CJ, Potokar JP. Serotonin reuptake inhibitor withdrawal. J Clin Psychopharmacol. 1996; 16:356-62. [IDIS 374384] [PubMed 8889907]
207. Rey-Sanchez F, Gutierrez Casares JR. Paroxetine in children with major depressive disorder: an open trial. J Am Acad Child Adolesc Psychiatry. 1997; 36:1443-7. [IDIS 393951] [PubMed 9334558]
208. American Academy of Child and Adolescent Psychiatry. Practice parameters for the assessment and treatment of children and adolescents with obsessive-compulsive disorder. J Am Acad Child Adolesc Psychiatry. 1998; 37(10 Suppl.):?.
209. Fiqueroa Y, Rosenberg DR, Birmaher B et al. Combination treatment with clomipramine and selective serotonin reuptake inhibitors for obsessive-compulsive disorder in children and adolescents. J Child Adolesc Psychopharmacol. 1998; 8:61-7. [PubMed 9639080]
210. Johnsen CR, Hoejlyng N. Hyponatremia following acute overdose with paroxetine. Int J Clin Pharmacol Ther. 1998; 36:333-5. [IDIS 409314] [PubMed 9660041]
211. Jenner PN. Paroxetine: an overview of dosage, tolerability, and safety. Int Clin Psychopharmacol. 1992; 6(Suppl. 4):69-80. [PubMed 1431015]
212. Molcho A, Stanley M. Antidepressants and suicide risk: issues of chemical and behavioral toxicity. J Clin Psychopharmacol. 1992; 12(2 Suppl.):13S-18S. [IDIS 293777] [PubMed 1577985]
213. Myers LB, Krenzelok EP. Paroxetine (Paxil) overdose: a pediatric focus. Vet Hum Toxicol. 1997; 39:86-8. [PubMed 9080633]
214. Liu BA, Mittmann N, Knowles SR et al. Hyponatremia and the syndrome of inappropriate secretion of antidiuretic hormone associated with the use of selective serotonin reuptake inhibitors: a review of spontaneous reports. CMAJ. 1996; 155:519-27. [IDIS 371725] [PubMed 8804257]
215. Bradley ME, Foote EF, Lee EN et al. Sertraline-associated syndrome of inappropriate antidiuretic hormone: case report and review of the literature. Pharmacotherapy. 1996; 16:680-3. [IDIS 370978] [PubMed 8840376]
216. Goldstein L, Barker M, Segall F et al. Seizure and transient SIADH associated with sertraline. Am J Psychiatry. 1996; 153:732. [IDIS 368977] [PubMed 8615425]
217. Kessler J, Samuels SC. Sertraline and hyponatremia. New Engl J Med. 1996; 335:524. [IDIS 370059] [PubMed 8676965]
218. Bouman WP, Johnson H, Trescoli-Serrano C et al. Recurrent hyponatremia associated with sertraline and lofepramine. Am J Psychiatry. 1997; 154:580. [IDIS 384231] [PubMed 9090354]
219. Anonymous. Selective serotonin reuptake inhibitors and SIADH: Adverse Drug Reactions Advisory Committee. Med J Austr. 1996; 164:562.
220. Thornton SL, Resch DS. SIADH associated with sertraline therapy. Am J Psychiatry. 1995; 152:809. [IDIS 346932] [PubMed 7726325]
221. Bluff DD, Oji N. SIADH in a patient receiving sertraline. Ann Intern Med. 1995; 123:811. [IDIS 356257] [PubMed 7574211]
222. Jackson C, Carson W, Markowitz J et al. SIADH associated with fluoxetine and sertraline therapy. Am J Psychiatry. 1995; 123:811.
223. Amsterdam JD, Garcia Espana F, Goodman D et al. Breast enlargement during chronic antidepressant therapy. J Affect Disord. 1997; 46:151-6. [PubMed 9479619]
224. Helmchen C, Boerner RJ, Meylendorf R et al. Reversible hepatotoxicity of paroxetine in a patient with major depression. Pharmacopsychiatry. 1996; 29:223-6. [PubMed 8956353]
225. De Man RA. Ernstige hepatitis toegeschreven aan paroxetine (Seroxat). Ned Tijdschr Geneeskd. 1997; 141:540-2. [PubMed 9190513]
226. Baldassano CF, Truman CJ, Nierenberg A et al. Akathisia: a review and case report following paroxetine treatment. Comp Psychiatry. 1996; 37:122-4.
227. Adler LA, Angrist BM. Paroxetine and akathisia. Biol Psychiatry. 1995; 37:336-7. [PubMed 7748986]
228. Dahl ML, Olhager E, Ahlner J. Paroxetine withdrawal syndrome on a neonate. Br J Psychiatry. 1997; 171:391-2. [IDIS 395472] [PubMed 9373435]
229. Mandalos GE, Szarek BL. Dose-related paranoid reaction associated with fluoxetine. J Nerv Ment Dis. 1990; 178:57-8. [PubMed 2295892]
230. Mills KC. Serotonin syndrome. Am Fam Physician. 1995; 52:11475-82.
231. Reynolds RD. Serotonin syndrome: what family physicians need to know. Am Fam Physician. 1995; 52:1263-71. [IDIS 354637] [PubMed 7572545]
232. Lappin RI, Auchincloss EL. Treatment of the serotonin syndrome with cyproheptadine. N Engl J Med. 1994; 330:1021-2. [PubMed 8121457]
233. Sporer KA. The serotonin syndrome. Implicated drugs, pathophysiology and management. Drug Saf. 1995; 13:94-104. [PubMed 7576268]
234. Graber MA, Hoehns TB, Perry PJ. Sertraline-phenelzine drug interaction: a serotonin syndrome reaction. Ann Pharmacother. 1994; 28:732-5. [IDIS 332591] [PubMed 7919561]
235. Steinberg H. Dear doctor letter regarding use of Zoloft (sertraline hydrochloride). New York, New York: Pfizer Inc, U.S. Pharmaceuticals Group; 1995 Aug 1.
236. Sternbach H. The serotonin syndrome. Am J Psychiatry. 1991; 148:705-13. [IDIS 282914] [PubMed 2035713]
237. Nierenberg DW, Semprebon M. The central nervous system serotonin syndrome. Clin Pharmacol Ther. 1993; 53:84-8. [IDIS 308978] [PubMed 8257462]
238. Brodribb TR, Downey M, Gilbar PJ. Efficacy and adverse effects of moclobemide. Lancet. 1994; 343:475. [IDIS 325641] [PubMed 7905962]
239. Kline SS, Mauro LS, Scala-Barnett DM et al. Serotonin syndrome versus neuroleptic malignant syndrome as a cause of death. Clin Pharm. 1989; 8:510-4. [IDIS 257026] [PubMed 2568897]
240. Eli Lilly and Company. Prozac (fluoxetine hydrochloride) capsules and oral solution prescribing information. Indianapolis, IN: 1999 Mar.
241. Wyeth-Ayerst. Redux (dexfenfluramine hydrochloride) capsules prescribing information. Philadelphia, PA; 1996 April 29.
242. Somerset Pharmaceuticals. Eldepryl (selegiline) capsules prescribing information (dated 1996 May). In: Physicians’ desk reference. 51st ed. Montvale, NJ: Medical Economics Company Inc; 1997:2729-31.
243. Mathew NT, Tietjen GE, Lucker C. Serotonin syndrome complicating migraine pharmacotherapy. Cephalalgia. 1996; 16:323-7. [PubMed 8869767]
244. Sternbach H. Danger of MAOI therapy after fluoxetine withdrawal. Lancet. 1988; 2:850-1. [IDIS 246846] [PubMed 2902292]
245. Feighner JP, Boyer WF, Tyler DL et al. Adverse consequences of fluoxetine-MAOI combination. J Clin Psychiatry. 1990; 51:222-5. [IDIS 267347] [PubMed 2347858]
246. Neuvonen PJ, Pohjola-Sintonen S, Tacke U. Five fatal cases of serotonin syndrome after moclobemide-citalopram or moclobemide-clomipramine overdoses. Lancet. 1993; 342:1419. [IDIS 322746] [PubMed 7901695]
247. Brannan SK, Talley BJ, Bowden CL. Sertraline and isocarboxazid cause a serotonin syndrome. J Clin Psychopharmacol. 1994; 14:144-5. [IDIS 327530] [PubMed 8195456]
248. Bhatara VS, Bandettini FC. Possible interaction between sertraline and tranylcypromine. Clin Pharm. 1993; 12:222-5. [IDIS 310301] [PubMed 8491079]
249. Coplan JD, Gorman JM. Detectable levels of fluoxetine metabolites after discontinuation: an unexpected serotonin syndrome. Am J Psychiatry. 1993; 150:837. [IDIS 314308] [PubMed 8480837]
250. Beasley CM, Masica DN, Heiligenstein JH et al. Possible monoamine oxidase inhibitor–serotonin uptake inhibitor interaction: fluoxetine clinical data and preclinical findings. J Clin Psychopharmacol. 1993; 13:312-20. [IDIS 320450] [PubMed 8227489]
251. Miller F, Friedman R, Tanenbaum J et al. Disseminated intravascular coagulation and acute myoglobinuric renal failure: A consequence of the serotonin syndrome. J Clin Psychopharmacol. 1991; 11:277-9. [IDIS 286360] [PubMed 1918432]
252. Jermaine DM. Potential fluoxetine-selegiline interaction. Ann Pharmacother. 1992; 26:1300.
253. Pollock BG, Mulsant BH, Nebes R et al. Serum anticholinergicity in elderly depressed patients treated with paroxetine or nortriptyline. Am J Psychiatry. 1998; 155:1110-2. [IDIS 412029] [PubMed 9699704]
254. Spigset O, Mjorndal T, Lovhelm O. Serotonin syndrome caused by a moclobemide- clomipramine interaction. BMJ. 1993; 306:248.
255. Blume CD. Dear doctor letter regarding use of Eldepryl. Tampa, FL: Somerset Pharmaceuticals; 1994 Nov 14.
256. Evans ML, Kortas KJ. Potential interaction between isoniazid and selective serotonin reuptake inhibitors. Am J Health-Syst Pharm. 1995; 52:2135-6. [IDIS 354730] [PubMed 8535949]
257. Ross RJ, Ball WA, Gresch PJ et al. REM sleep suppression by monoamine reuptake blockade: development of tolerance with repeated drug administration. Biol Psychiatry. 1990; 28:231-239. [PubMed 2165825]
258. Ozdemir V, Naranjo CA, Shulman RW et al. Determinants of interindividual variability and extent of CYP2D6 and CYP1A2 inhibition by paroxetine and fluvoxamine in vivo. J Clin Psychopharmacol. 1998; 18:198-207. [IDIS 407017] [PubMed 9617978]
259. Ball SE, Ahern D, Scatina J et al. Venlafaxine: in vitro inhibition of CYP2D6 dependent imipramine and desipramine metabolism; comparative studies with selected SSRIs, and effects on human hepatic CYP3A4, CYP2C9 and CYP1A2. Br J Clin Pharmacol. 1997; 43:619-26. [PubMed 9205822]
260. Jeppesen U, Gram LF, Vistisen K et al. Dose-dependent inhibition of CYP1A2, CYP2C19 and CYP2D6 by citalopram, fluoxetine, fluvoxamine and paroxetine. Eur J Clin Pharmacol. 1996; 51:73-8. [IDIS 373195] [PubMed 8880055]
261. Ozdemir V, Naranjo CA, Herrmann N et al. Paroxetine potentiates the central nervous system side effects of perphenazine: contribution of cytochrome P4502D6 inhibition in vivo. Clin Pharmacol Ther. 1997; 62:334-7. [IDIS 394954] [PubMed 9333110]
262. Greb WH, Buscher G, Dierdorf HD et al. The effect of liver enzyme inhibition by cimetidine and enzyme induction by phenobarbitone on the pharmacokinetics of paroxetine. Clin Pharmacol Ther. 1997; 62:334-7. [IDIS 394954] [PubMed 9333110]
263. Heinemann F, Assion HJ, Hermes G et al. Paroxetine-induced neuroleptic malignant syndrome. Nervenarzt. 1989; 80(Suppl. 350):102-106.
264. Belpaire FM, Wijnant P, Temmerman A et al. The oxidative metabolism of metoprolol in human liver microsomes: inhibition by the selective serotonin reuptake inhibitors. Eur J Clin Pharmacol. 1998; 54:261-4. [PubMed 9681670]
265. Stock AJ, Kofoed L. Therapeutic interchange of fluoxetine and sertraline: experience in the clinical setting. Am J Hosp Pharm. 1994; 51:2279-2281. [PubMed 7801990]
266. Schleis T. Realities of the fluoxetine-to-sertraline switch. Am J Health-Syst Pharm. 1995; 52:423. [IDIS 342146] [PubMed 7757876]
267. Rosenblatt JE, Rosenblatt NC. How long a hiatus between discontinuing fluoxetine and beginning sertraline? Curr Affect Illness. 1992; 11(8):2. Abstract.
268. Montejo AI, Llorca G, Izquierdo JA et al. Sexual dysfunction secondary to SSRIs: a comparative analysis in 308 patients. Actas Luso Esp Neurol Psiquiatr Cienc Afines. 1996; 24:311-21. [PubMed 9054202]
269. Montejo Gonzales AL, Llorca G, Izquierdo JA et al. SSRI-induced sexual dysfunction: fluoxetine, paroxetine, sertraline, and fluvoxamine. J Sex Marital Ther. 1997; 23:176-94. [PubMed 9292833]
270. Modell JG, Katholi CR, Modell JD et al. Comparative sexual side effects of bupropion, fluoxetine, paroxetine, and sertraline. Clin Pharmacol Ther. 1997; 61:476-87. [IDIS 385693] [PubMed 9129565]
271. SmithKline Beecham Pharmaceuticals, Philadelphia, PA: Personal communication.
272. Ballenger MC, Davison JRT, Lucribier Y et al. Consensus statement on panic disorder from the International Consensus Group on Depression and Anxiety. J Clin Psychiatry. 1998; 59(Suppl 8):47-54.
273. National Institutes of Health Office of Medical Applications of Research. NIH consensus statement: diagnosis and treatment of depression in late life. 1991; 9;1-27.
274. Lebowitz BD, Pearson JL, Schneider LS et al. Diagnosis and treatment of depression in late life. Consensus statement update. JAMA. 1997; 278:1186-90. [IDIS 392714] [PubMed 9326481]
275. Fava M. New approaches to treatment of refractory depression. J Clin Psychiatry. 2000:61 (Suppl 1):26-32.
276. Nelson JC. Augmentation strategies in depression 2000. J Clin Psychiatry. 2000:61(Suppl 2):13-9.
277. Novartis Pharmaceuticals. Mellaril (thioridazine hydrochloride) tablets and oral solution and Mellaril-S (thioridazine hydrochloride) oral suspension prescribing information. 2000 June.
278. Kennedy SH, Eisfeld BS, Dickens SE et al. Antidepressant-induced sexual dysfunction during treatment with moclobemide, paroxetine, sertraline, and venlafaxine. J Clin Psychiatry. 2000;61:276-81.
279. Rosen RC, Lane RM, and Menza M. Effects of SSRIs on sexual function: a critical review. J Clin Psychopharm. 1999; 19:67-85.
280. McMahon CG, Touma K. Treatment of premature ejaculation with paroxetine hydrochloride as needed: 2 single-blind placebo controlled crossover studies. J Urol. 1999; 161:1826-30. [IDIS 428228] [PubMed 10332446]
281. McMahon CG, Touma K. Treatment of premature ejaculation with paroxetine hydrochloride. Int J Impot Res. 1999; 11:241-5. [PubMed 10553802]
282. Ambrosini PJ. A review of pharmacotherapy of major depression in children and adolescents. Psyciatr Ser. 2000; 51:627-33.
283. Hughes CW, Emslie GJ, Crismon ML et al. The Texas children’s medication algorithm project: report of the Texas Consensus Conference Panel on Medication Treatment of Childhood Major Depressive Disorder. J Am Acad child Adolesc Psychiatry. 1999; 38:1442-54. [IDIS 439422] [PubMed 10560232]
284. American Academy of Child and Adolescent Psychiatry. Practice parameters for the assessment and treatment of children and adolescents with depressive disorders. J Am Acad Child Adolesc Psychiatry. 1998; 37(Suppl 10):63S-83S. [IDIS 415552] [PubMed 9785729]
285. Emslie GJ, Rush J, Weinberg WA et al. A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression. Arch Gen Psychiatry. 1997; 54:1031-7. [IDIS 396287] [PubMed 9366660]
286. Novartis. Clozaril (clozapine) tablets prescribing information. East Hanover, NJ; 1999 Sept.
287. Ellingrod VL. Pharmacotherapy of primary obsessive-compulsive disorder: review of the literature. Pharmacotherapy. 1998; 18:936-60. [IDIS 416228] [PubMed 9758307]
288. Griest JH, Jefferson JW. Pharmacotherapy for obsessive-compulsive disorder. Br J Psychiatry. 1998; 35:64-70.
289. American Psychiatric Association. Diagnostic and statistical manual of mental disorders: DSM-IV-TR™. 4th ed. Washington, DC: American Psychiatric Association; 2000:473-7.
290. Pollack MH, Zaninelli R, Goddard A et al. Paroxetine in the treatment of generalized anxiety disorder: results of a placebo-controlled, flexible-dosage trial. J Clin Psychiatry. 2001; 62:350-7. [IDIS 464452] [PubMed 11411817]
291. Ballenger JC, Davidson JR, Lecrubier Y et al. Consensus statement on generalized anxiety disorder from the International Consensus Group on Depression and Anxiety. J Clin Psychiatry. 2001; 62(Suppl 11):53-8. [IDIS 465110] [PubMed 11414552]
292. GlaxoSmithKline, Philadelphia; PA: Personal communication.
293. Ballenger JC. Clinical guidelines for establishing remission in patients with depression and anxiety. J Clin Psychiatry. 1999; 60(Suppl 22):29-34. [IDIS 440043] [PubMed 10634353]
294. Rocca P, Fonzo V, Scotta M et al. Paroxetine efficacy in the treatment of generalized anxiety disorder. Acta Psychiatr Scand. 1997; 95:444-450. [PubMed 9197912]
295. GlaxoSmithKline. Paxil (paroxetine hydrochloride) tablets and oral suspension prescribing information. 2001 Dec.
296. Marshall RD, Beebe KL, Oldham M et al. Efficacy and safety of paroxetine treatment for chronic PTSD: a fixed-dose, placebo-controlled study. Am J Psychiatry. 2001; 158:1982-8. [IDIS 473298] [PubMed 11729013]
297. Tucker P, Zaninelli R, Yehuda R et al. Paroxetine in the treatment of chronic posttraumatic stress disorder: results of a placebo-controlled, flexible-dosage trial. J Clin Psychiatry. 2001; 62:860-8. [IDIS 473522] [PubMed 11775045]
298. Smajkic A, Weine S, Djuric-Bijedic Z et al. Sertraline, paroxetine, and venlafaxine in refugee posttraumatic stress disorder with depression symptoms. J Trauma Stress. 2001; 14:445-52. [PubMed 11534876]
299. Eke T, Bates AK. Acute angle closure glaucoma associated with paroxetine. BMJ. 1997; 314:1387. [IDIS 385074] [PubMed 9161312]
300. The Expert Consensus Panels for PTSD. The expert consensus guideline series: treatment of posttraumatic stress disorder. J Clin Psychiatry. 1999; 60(Suppl 16):3-76.
301. Turner S. Place of pharmacotherapy in post-traumatic stress disorder. Lancet. 1999; 354:1404-5. [IDIS 435452] [PubMed 10543663]
302. Van Etten ML. Comparative efficacy of treatments for post-traumatic stress disorder: a meta-analysis. Clin Psychol Psychother. 1998; 5:126-44.
303. International Society for Traumatic Stress Studies. Practice guideline for the treatment of post-traumatic stress disorder. Northbrook, IL; March 2000. From the International society for traumatic stress studies website.
304. GlaxoSmithKline. Paxil CR (paroxetine hydrochloride) controlled-release tablets prescribing information. 2002 Apr.
305. American Psychiatric Association. Practice guideline for the treatment of patients with bipolar disorder. Am J Psychiatry (Revision). 2002; 159(Suppl 12):1-50.
306. Anon. FDA Statement Regarding the Anti-Depressant Paxil for Pediatric Population. FDA Talk Paper. Rockville, MD: Food and Drug Administration; 2003 Jun 19. From the FDA website.
307. Anon. Questions and Answers on Paxil (paroxetine hydrochloride). Rockville, MD: Food and Drug Administration; 2003 Jun 19. From the FDA website.
308. Duff G. Dear colleague letter regarding safety of Seroxat (paroxetine) in children and adolescents under 18 years—contraindication in the treatment of depressive illness. From the Medicines and Healthcare Products Regulatory Agency (MHRA) website.
309. Anon. Are SSRIs safe for children? Med Lett Drugs Ther. 2003; 45:53-4.
310. Anon. FDA issues public health advisory entitled: Reports of suicidality in pediatric patients being treated with antidepressant medications for major depressive disorder (MDD). FDA Talk Paper. Rockville, MD: Food and Drug Administration; 2003 Oct 27. From the FDA website.
311. Anon. Reports of suicidality in pediatric patients being treated with antidepressant medications for major depressive disorder (MDD). FDA Public Health Advisory. Rockville, MD: Food and Drug Administration; 2003 Oct 27. From the FDA website.
312. GlaxoSmithKline. Paxil CR (paroxetine hydrochloride) controlled-release tablets prescribing information. 2005 Sep.
313. Reviewers’ comments (personal observations) on citalopram 28:16.04.20.
314. Food and Drug Administration. Class suicidality labeling language for antidepressants. From the FDA website.
315. Food and Drug Administration. Public health advisory: suicidality in children and adolescents being treated with antidepressant medications. Rockville, MD; 2004 Oct 15. From the FDA website.
316. Anon. FDA statement on recommendations of the psychopharmacologic drugs and pediatric advisory committees. Rockville, MD; 2004 Sep 16. From the FDA website.
317. American Psychiatric Association (APA). APA responds to FDA’s new warning on antidepressants. Arlington, VA; 2004 Oct. 15. From the APA website.
318. American Academy of Child and Adolescent Psychiatry (AACAP). AACAP responds to the new FDA warnings on pediatric antidepressant medications. Washington, DC; 2004 Oct 15. From the AACAP website.
319. American Academy of Pediatrics (AAP). Children, antidepressants and a black box warning. Washington, DC; 2004 Oct. 15. From the AAP website.
320. Food and Drug Administration. Medication guide: about using antidepressants in children or teenagers. Rockville, MD; 2005 Jan 16. From the FDA website.
321. Stocchi F, Nordera G, Jokinen RH et al. Efficacy and tolerability of paroxetine for the long-term treatment of generalized anxiety disorder. J Clin Psychiatry. 2003; 64:250-8.
322. Spina E, Avenoso A, Facciola G et al. Plasma concentrations of risperidone and 9-hydroxyrisperidone during combined treatment with paroxetine. Ther Drug Monit. 2001; 23:223-7.
323. Dalton SO, Johansen C, Mellemkjaer L et al. Use of selective serotonin reuptake inhibitors and risk of upper gastrointestinal tract bleeding: a population-based cohort study. Arch Intern Med. 2003; 163:59-64.
324. van Walraven C, Mamdani MM, Wells PS et al. Inhibition of serotonin reuptake by antidepressants and upper gastrointestinal bleeding in elderly patients: retrospective cohort study. BMJ. 2001; 323:655-8.
325. de Abajo FJ, Rodriguez LA, Montero D. Association between selective serotonin reuptake inhibitors and upper gastrointestinal bleeding: population based case-control study. BMJ. 1999; 319:1106-9.
326. Dear healthcare professional letter regarding changing the Pregnancy subsection of the Precautions section in the labels for Paxil (paroxetine HCl) and Paxil (paroxetine HCl) CR. Philadelphia, PA: GlaxoSmithKline; 2005 Sep.
327. Morag I, Batash D, Keidar R et al. Paroxetine use throughout pregnancy: does it pose any risk to the neonate? J Toxicol Clin Toxicol. 2004; 42:97-100.
328. Haddad PM, Pal BR, Clarke P et al. Neonatal symptoms following maternal paroxetine treatment: serotonin toxicity or paroxetine discontinuation syndrome? J Psychopharmacol. 2005; 19:554-7.
329. Moses-Kolko EL, Bogen D, Perel J et al. Neonatal signs after late in utero exposure to serotonin reuptake inhibitors: literature review and implications for clinical applications. JAMA. 2005; 293:2372-85.
330. Sanz EJ, De-Las-Cuevas C, Kiuru A et al. Selective serotonin reuptake inhibitors in pregnant women and neonatal withdrawal syndrome: a database analysis. Lancet. 2005; 365:482-7.
331. Nordeng H, Lindemann R, Perminov KV et al. Neonatal withdrawal syndrome after in utero exposure to selective serotonin-reuptake inhibitors. Acta Paediatr. 2001; 90:288-91.
332. Dahl ML, Olhager E, Ahlner J. Paroxetine withdrawal syndrome in a neonate. Br J Psychiatr. 1997; 171:391-2.
333. Kulin NA, Pastuszak A, Sage SR et al. Pregnancy outcome following maternal use of the new selective serotonin reuptake inhibitors: a prospective controlled multicenter study. JAMA. 1998; 279:609-10.
334. Hendrick V, Smith LM, Suri R et al. Birth outcomes after prenatal exposure to antidepressant medication. Am J Obstet Gynecol. 2003; 188:812-5.
335. Belle DJ, Ernest CS, Sauer JM et al. Effect of potent CYP2D6 inhibition by paroxetine on atomoxetine pharmacokinetics. J Clin Pharmacol. 2002; 42:1219-27. [IDIS 488707] [PubMed 12412820]
336. Eli Lilly and Company. Strattera (atomoxetine hydrochloride) capsules prescribing information. Indianapolis, IN; 2005 May 26.
337. Dear healthcare professional letter regarding further revisions to the labels for Paxil (paroxetine HCl) and Paxil (paroxetine HCl) CR in the pregnancy precautions and warnings section. Philadelphia, PA: GlaxoSmithKline; 2005 Dec.
338. Food and Drug Administration. Public health advisory: paroxetine. Rockville, MD; 2005 Dec 8. From the FDA website.
a. GlaxoSmithKline. Paxil (paroxetine hydrochloride) tablets and oral suspension prescribing information. 2006 May.
b. Dear healthcare professional letter regarding changes to the Clinical Worsening and Suicide Risk subsection of the Warnings section in the labels for Paxil (paroxetine hydrochloride) and Paxil CR (paroxetine HCl). Philadelphia, PA: GlaxoSmithKline; 2006 May.
c. GlaxoSmithKline. Paxil CR (paroxetine hydrochloride) controlled-release tablets prescribing information. 2006 May.