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 data show that the risk of birth defect is up to 16 times higher among girls who took topiramate or its generic equivalents in the course of pregnancy.
Topiramate is approved by the FDA for treating seizures associated with epilepsy and to prevent migraines. But it is also sometimes employed on an off-label basis to treat other circumstances, such as obesity, bipolar disorder, and alcoholism.
“Well being care experts ought to cautiously consider the positive aspects and risks of topiramate when prescribing it to females of childbearing age,” Russell Katz, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Study, says in a statement. “Alternative medications that have a lower risk of birth defects really should be thought to be.”
Citing information from the North American Antiepileptic Drug (AED) Pregnancy Registry, the FDA says 1.four% of infants exposed to topiramate in the course of pregnancy developed cleft lip or cleft palate, compared with .38-.55% of infants exposed to other epilepsy drugs. The threat of these oral cleft birth defects was significantly lower among infants of mothers who did not take epilepsy drugs in the course of pregnancy (.07%). These alarming numbers have sparked some people’s interest in pursuing a Topamax birth defect lawsuit.
Similar outcomes have been reported in European drug registries.
Upgraded Pregnancy Warning
In response to this new details, the FDA says topiramate will have a stronger warning on its label. The warning in the pregnancy category has been altered from category C to a category D threat, which signifies there is positive evidence of fetal threat based on human information.
Cleft lip and cleft palate are birth defects that happen when parts of the lip or palate do not fuse together throughout the initial trimester of pregnancy. The defects range from a tiny notch in the lip to a groove that runs into the roof of the mouth and nose that can lead to problems with consuming and talking and to ear infections.
Researchers say with remedy, typically corrective surgery, most young children with cleft lip or cleft palate do well.
FDA officials warn that pregnant females and women of childbearing age must go over other therapy options with their wellness care specialist prior to taking topiramate. Women taking topiramate ought to tell their wellness care expert instantly 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 should not quit taking it unless told to do so by their doctor.
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