In a previous blog post, we discussed the recent FDA announcement regarding new data linking Topamax and birth defects. We also explained cleft palate and cleft lip birth defects, which are collectively referred to as oral clefts, and how data suggests they are Topamax-caused birth defects. Topamax is used as anti-seizure medication for those who have epilepsy.
The severity of the Topamax oral birth defects can vary; ranging from a small notch on the infant’s lip to a groove running into the roof of their nose and mouth. Babies who are born with the cleft palate or cleft lip birth defect can have difficulty eating, talking, and may also have ear infections. Cleft palate treatment is available in which surgery is performed to close an infant’s lip and palate. After the cleft palate repair, most children do well.
According to the new data from the North American Antiepileptic Drug (AED) Pregnancy Registry, infants who are born to women taking Topamax had a 1.4 percent occurrence of oral clefts, which is significantly larger than the 0.38 percent – 0.55 percent occurrence in infants who were exposed to other antiepileptic drugs. Infants born to women who were not taking antiepileptic drugs only had an occurrence rate of 0.07 percent.
Based upon the new data, the FDA advises healthcare professionals to consider the risks and benefits of Topamax before prescribing it to women of childbearing age. They should also consider prescribing alternative medications with a lower risk of birth defects. The FDA has stated Topamax and its topiramate generic versions will have an updated, stronger warning on its prescribing information.
At Anapol Weiss, our Topamax birth defect attorneys have a national reputation for successfully handling our clients’ pharmaceutical liability claims. We are continuing to investigate Topamax and its effects on a woman’s first trimester of pregnancy. If you believe you have a valid Topamax lawsuit, please contact our law firm for a free consultation. Call 1-866-735-2792 today.