Topiramate, the active ingredient in Topamax,could be an effective long-term weight loss treatment.
A new weight loss medication recently announced that long-term use can lead to a potential risk of serious birth defects when used during early pregnancy, such as the risk of cleft lip and palate, it contains the same active pharmaceutical ingredient used for an epilepsy.
According to a study published in the latest issue of the medical journal The Lancet, the combination of the weight loss drug, phentermine and Topiramate, the active ingredient in Topomax, could be an effective long-term weight loss treatment. However, the study results were released a month after the FDA warned of a possible risk of cleft lip and cleft palate when the drug Topamax was used during pregnancy.
The study was a 56-week trial in 2,487 overweight patients that were given a combination of phentermine and Topamax in various doses, or placebo. Patients receiving low doses of the drug lost an average of 18 pounds during the study, patients with high doses lost 22 pounds and those receiving a placebo lost three kilos, investigators say there were nine pregnancies during the study, but none resulted in a child being born with birth defects. Side effects observed include dry mouth, constipation, insomnia and dizziness.
Earlier this year, as part of its review of the proposed new drug combination, the FDA required pharmaceutical Vivus, Inc. to review the reports that Topamax can cause potential cleft palate and cleft lip in children born to women taking Topamax during pregnancy.
Topamax (Topiramate) was approved for the treatment of epilepsy, a neurological disorder characterized by recurrent seizures without control. In 2004, the FDA approved Topamax for an additional use of treating severe headaches known as migraines, it is also used off-label by many doctors to treat bipolar disorder. Generic forms of the drug began to appear in 2006.
On 4 March, the FDA announced that the new warnings were added to the product label about the risk of oral clefts when the drug Topamax used during the first trimester of pregnancy, a time when many women do not even know they are pregnant. The FDA urged doctors to avoid giving Topamax to women who are pregnant or of childbearing age and a high risk of pregnancy, such as alternative drugs may not carry the same risk to the fetus.
Cleft palate and cleft lip occurs when parts of the lip or palate do not fuse completely. The defect in children born with defects as small as a lip notched to end as an open groove running from the roof of the mouth to the nose, cleft palate and cleft lip can cause problems with eating and speaking and may increase the risk of ear infections, resulting in the need for corrective surgery. A number of women who have given birth to children with a defect or malformation after using the drug during pregnancy are considering a lawsuit against potential Topamax drug manufacturers because of its failure to investigate the risks associated with pregnancy.