Taking the epilepsy drug topiramate (Topamax) in the course of pregnancy raises the risk 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 threat of birth defect is up to 16 times higher amongst girls who took topiramate or its generic equivalents during pregnancy.
Topiramate is approved by the FDA for treating seizures related with epilepsy and to prevent migraines. But it is also often employed on an off-label basis to treat other circumstances, such as obesity, bipolar disorder, and alcoholism.
“Wellness care specialists really should meticulously think about the benefits and dangers of topiramate when prescribing it to women of childbearing age,” Russell Katz, MD, director of the Division of Neurology Merchandise in the FDA’s Center for Drug Evaluation and Investigation, says in a statement. “Alternative medicines that have a lower danger of birth defects should be deemed.”
Citing details from the North American Antiepileptic Drug (AED) Pregnancy Registry, the FDA says 1.4% of infants exposed to topiramate during pregnancy developed 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 among infants of mothers who did not take epilepsy drugs throughout pregnancy (.07%). These alarming numbers have sparked some people’s interest in pursuing a Topamax birth defect lawsuit.
Related results 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 altered from category C to a category D danger, which means 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 throughout the 1st 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 problems with consuming and talking and to ear infections.
Researchers say with remedy, normally corrective surgery, most young children with cleft lip or cleft palate do well.
FDA officials warn that pregnant ladies and women of childbearing age ought to discuss other remedy possibilities with their wellness care skilled ahead of taking topiramate. Girls taking topiramate ought to tell their well being care expert right away if they are pregnant or arranging to turn into pregnant. Women who took Topamax during pregnancy and bore childrent with a Topamax birth defect should consider a topamax lawsuit.
Folks taking topiramate really should not stop taking it unless told to do so by their medical doctor.
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