The FDA will be adding a stronger warning to the packaging label of the drug, Topamax®. The warning will alert patients of a potential risk of birth defects in children whose mothers take the medication while pregnant.
The agency sent a letter to notify healthcare professionals about the birth defect risk March 4, 2011. The FDA says babies are risk of developing cleft lip and/or cleft palate when their mothers take Topamax® (topiramate) in their first trimester.
Topamax® (topiramate) has been placed in Pregnancy Category D, which means the drug has been linked to the development of birth defects. For some patients, however, the benefit if taking the drug might outweigh the birth defect risk.
The FDA has asked healthcare providers to warn female patients about the risk. The FDA has also stated that patients who become pregnant while taking Topamax® (topiramate) should speak to their doctors before stopping use.
Topamax® is used for the treatment of seizures. It is an anticonvulsant medication prescribed for the treatment of epilepsy. It is either used alone or in conjunction with other medications.
(Source: FDA)
If your baby is born with cleft lip or cleft palate, a defective drug lawyer may be able to help you seek compensation if you were treated with Topamax® during your pregnancy. For more information, please contact us today.
