Warnings on the drug, topiramate (brand name Topamax), an anti-seizure medication sold by Johnson & Johnson, will be strengthened by the U.S. Food and Drug Administration (FDA) due to new data that suggests an increased risk of birth defects when used during pregnancy.
According to the agency, data compiled by the North American Antiepileptic Drug (AED) Pregnancy Registry, indicates an increased risk of oral clefts in infants exposed to Topamax or generic rivals, during the first trimester of pregnancy. Infants exposed to topiramate as a single therapy had a 1.4 percent prevalence of oral clefts, compared with a 0.38 to 0.55 percent in those exposed to other antiepileptic drugs.
Adversely, infants of mothers who did not have epilepsy and were not being treated with other anti-seizure drugs had a prevalence of 0.07 percent.
Oral clefts are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy.
The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, which can lead to problems with speech, ear infections and eating. Surgery is often required to close the lip and palate.
Before topiramate is prescribed, health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while taking this drug. This drug is also used to prevent, not relieve migraines.
FDA’s Russell Katz, M.D., who heads the agency’s Division of Neurology Products, says “Health care professionals should carefully weigh the benefits and risks of topiramate when prescribing it to women of childbearing age.”
“Alternative medications that have a lower risk of birth defects should be considered.”
In a statement, J&J said Topamax’s label already notes the risks associated with pregnancy and "recommended cautious use in pregnant patients." But, the warning in the pregnancy category has been changed from category C to a category D risk, which means there is positive evidence of fetal risk based on human data.
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