Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
*Change in Table 13 to describe effect of lamotrigine on valproate concentrations
- … There are conflicting study results regarding effect of lamotrigine on valproate concentrations…
How should I take LAMICTAL?
- If you take too much LAMICTAL, call your healthcare provider or your local Poison Control Center or go to the nearest hospital emergency room right away.
- Nervous System: Aseptic meningitis
- Blood and Lymphatic: Lymphadenopathy not associated with hypersensitivity disorder
WARNINGS AND PRECAUTIONS
Multiorgan Hypersensitivity Reactions and Organ Failure
- Multiorgan hypersensitivity reactions, also known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have occurred with Lamictal…
USE IN SPECIFIC POPULATIONS
- Lamotrigine is present in milk from lactating women taking Lamictal…
What should I tell my healthcare provider before taking Lamictal…
- are breastfeeding….and may cause side effects in a breastfed baby. If you breastfeed while taking Lamictal…
What should I tell my healthcare provider before taking Lamictal ?
- have had aseptic meningitis after taking Lamictal
WARNINGS AND PRECAUTIONS
Multiorgan Hypersensitivity Reactions and Organ Failure (Revised)
- Multiorgan hypersensitivity reactions, also known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have occurred with Lamictal. Some have been fatal or life threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy in association with other organ system involvement, such as hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis, sometimes resembling an acute viral infection. Eosinophilia is often present. This disorder is variable in its expression and other organ systems not noted here may be involved.
- Fatalities associated with acute multiorgan failure and various degrees of hepatic failure have been reported in 2 of 3,796 adult patients and 4 of 2,435 pediatric patients who received Lamictal in epilepsy clinical trials. Rare fatalities from multiorgan failure have also been 292 reported in postmarketing use.
- Isolated liver failure without rash or involvement of other organs has also been reported with Lamictal..
- It is important to note that early manifestations of hypersensitivity (e.g., fever, lymphadenopathy) may be present even though a rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Lamictal XR should be discontinued if an alternative etiology for the signs or symptoms cannot be established.
- Prior to initiation of treatment with Lamictal. XR, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (e.g., fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.