Why did the Food and Drug Administration issue a warning about Topamax?
The FDA issued a Topamax warning in March 2011 after data from the North American Antiepileptic Drug Pregnancy Registry (NAAED) revealed that women who use Topamax while pregnant are more likely to give birth to a child with cleft lip or cleft palate.
What is the risk of birth defects from Topamax during pregnancy?
Pregnant women who use Topamax are 21-times more likely to give birth to a child with oral cleft defects such as a cleft lip or cleft palate, according to NAAED data. In addition, Topamax users who take the drug while pregnant are three times more likely to give birth to a child with these oral cleft defects compared to users of other antiepilepsy drugs.
What actions did the FDA take in response to the NAAED data?
Based on information about the increased risk of birth defects for children born to women who use Topamax during their pregnancy, the FDA upgraded the drug from its Pregnancy Category C to Category D. Drugs which are identified as Category D have a proven risk of causing birth defects.
What is Topiramate?
Topiramate is the generic version of Topamax. Topiramate went on sale in the U.S. starting in March 2009. Many women who were prescribed Topamax may have been given Topiramate by their pharmacists instead. Because of its chemical similarities to Topamax, women who use Topiramate during pregnancy are also at an increased risk of giving birth to a child with oral cleft defects or other birth defects.
Could Topamax cause other birth defects besides oral cleft defects?
Children whose mothers took Topamax while pregnant or generic Topiramate may also suffer from other congenital birth defects, including spina bifida, hypospadias or other genital malformations, persistent pulmonary hypertension of the newborn (PPHN) or other heart and lung defects, limb malformations, craniofacial defects or neural tube defects.
Will the FDA recall Topamax?
Despite its warnings about the increased risk of birth defects associated with the drug, the FDA has not announced plans to issue a Topamax recall.
Is Topamax approved for the treatment of conditions besides epilepsy and migraines?
Although Topamax was promoted by its manufacturers for the treatment of bipolar disorder, weight loss, alcohol dependency and other conditions, Topamax has only been approved by the FDA for the treatment of epilepsy and migraines. In May 2010, two subsidiaries of Johnson & Johnson agreed to pay fines of $81.5 million for illegally promoting the drug for these off-label uses.
Am I eligible to file a Topamax lawsuit?
If you or a loved one took Topamax while pregnant or generic Topiramate and gave birth to a child with cleft lip, cleft palate or other side effects, contact the lawyers at Hissey Kientz, LLP to learn more about your legal rights. You can reach us by calling toll-free at 1-866-275-4454, or by filling out the free case evaluation form to the right of this page.