Taking the epilepsy drug topiramate (Topamax) throughout 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 greater amongst women who took topiramate or its generic equivalents throughout pregnancy.
Topiramate is approved by the FDA for treating seizures associated with epilepsy and to prevent migraines. But it is also at times used on an off-label basis to treat other conditions, such as obesity, bipolar disorder, and alcoholism.
“Health care specialists must meticulously think about the advantages and risks of topiramate when prescribing it to ladies of childbearing age,” Russell Katz, MD, director of the Division of Neurology Goods in the FDA’s Center for Drug Evaluation and Study, says in a statement. “Alternative medications that have a lower danger of birth defects must be deemed.”
Citing details from the North American Antiepileptic Drug (AED) Pregnancy Registry, the FDA says 1.four% of infants exposed to topiramate for the duration 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 much lower amongst infants of mothers who did not take epilepsy drugs for the duration of pregnancy (.07%). These alarming numbers have sparked some people’s interest in pursuing a Topamax birth defect lawsuit.
Related 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 danger, which signifies there is positive evidence of fetal risk based on human information.
Cleft lip and cleft palate are birth defects that occur when parts of the lip or palate do not fuse together throughout 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 difficulties with eating and talking and to ear infections.
Researchers say with therapy, generally corrective surgery, most children with cleft lip or cleft palate do well.
FDA officials warn that pregnant females and girls of childbearing age really should go over other remedy options with their health care expert just before taking topiramate. Females taking topiramate ought to tell their health care skilled right away if they are pregnant or organizing to turn into pregnant. Women who took Topamax during pregnancy and bore childrent with a Topamax birth defect should consider a topamax lawsuit.
People taking topiramate ought to not quit taking it unless told to do so by their medical doctor.
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