topamax lawsuit

Taking the epilepsy drug topiramate (Topamax) in the course of pregnancy raises the danger of oral cleft birth defects such as cleft lip and cleft palate, according to a new warning issued by the FDA.

New drug registry information show that the threat of birth defect is up to 16 occasions greater among women who took topiramate or its generic equivalents for the duration of pregnancy.

Topiramate is approved by the FDA for treating seizures connected with epilepsy and to avoid migraines. But it is also sometimes utilised on an off-label basis to treat other conditions, such as obesity, bipolar disorder, and alcoholism.

“Health care specialists should carefully contemplate the positive aspects and dangers of topiramate when prescribing it to women of childbearing age,” Russell Katz, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Analysis, says in a statement. “Option medications that have a lower danger of birth defects really should be thought to be.”

Citing info from the North American Antiepileptic Drug (AED) Pregnancy Registry, the FDA says 1.four% of infants exposed to topiramate for the duration of pregnancy created cleft lip or cleft palate, compared with .38-.55% of infants exposed to other epilepsy drugs. The risk of these oral cleft birth defects was a lot lower amongst infants of mothers who did not take epilepsy drugs during pregnancy (.07%). These alarming numbers have sparked some people’s interest in pursuing a Topamax birth defect lawsuit.

Comparable outcomes have been reported in European drug registries.
Upgraded Pregnancy Warning

In response to this new information, the FDA says topiramate will have a stronger warning on its label. The warning in the pregnancy category has been changed from category C to a category D threat, which implies there is positive evidence of fetal danger based on human data.

Cleft lip and cleft palate are birth defects that occur when parts of the lip or palate do not fuse together during the initial trimester of pregnancy. The defects range from a modest notch in the lip to a groove that runs into the roof of the mouth and nose that can lead to issues with eating and talking and to ear infections.

Researchers say with remedy, generally corrective surgery, most youngsters with cleft lip or cleft palate do nicely.

FDA officials warn that pregnant females and ladies of childbearing age ought to discuss other therapy options with their wellness care professional prior to taking topiramate. Ladies taking topiramate ought to tell their wellness care skilled right away if they are pregnant or planning to turn out to be pregnant. Women who took Topamax during pregnancy and bore childrent with a Topamax birth defect should consider a topamax lawsuit.

People taking topiramate really should not cease taking it unless told to do so by their medical doctor.