Topamax Birth Defects

Though Topamax side effects are well known, it wasn’t until the FDA announced on March 4, 2011, that data collected by multiple independent sources indicated a significant increase in Topamax birth defects including the risk of oral clefts among infants exposed to Topamax’s active ingredient, topiramate. This led to an FDA-required change of Topamax’s label to indicate this documented Topamax birth defect risk, as well as the FDA’s reclassification of the drug from Pregnancy Category C (not studied in pregnant women, but benefits more likely to outweigh risk) to Category D (potential to  cause significant, unreasonable harm to a human fetus, benefits may outweigh risk only in certain situations).

Despite the FDA’s announcement, some consumers remained uninformed. Worse yet, those who were informed about the increased risk of Topamax birth defects could have had difficulty discontinuing the medication, since suddenly stopping regular dosage of Topamax can result in significant withdrawal effects.

Topamax Birth Defects: Cleft Lip and Cleft Palate

Cleft lip, sometimes called harelip, and cleft palate are Topamax birth defects that occur when parts of the lip or palate do not completely fuse together during fetal development in the early stages of the first trimester. Clefts can give rise to a variety of problems including difficulty feeding and raised likelihood for ear disease, speech disorders and socialization complexes.

Though expensive surgeries can typically repair the malformed clefts shortly after birth, the victim is left with a high likelihood of scarring, and therefore an increased risk of psychosocial problems from resulting physical abnormalities.

Studies on Topamax Birth Defects

The North American Antiepilepsy Drug (NAAED) Pregnancy Registry recently released data indicating nearly a 2000% increase in risk of Topamax birth defects including oral cleft lip compared to the non-AED-taking population, and a 400% increase compared to antiepileptic drugs not containing topiramate.

The UK Epilepsy and Pregnancy Register confirmed the findings of the NAAED Registry in a study published by Neurology, showing the risk of Topamax birth defects such as oral cleft lip and cleft palate to be sixteen times higher than the background population.

The increased risk in Topamax birth defects is present in any topiramate-based drug. If you and your child have been affected by Topamax birth defects, you should speak with our Topamax lawyers who have experience in medical products liability and a penchant for “doing good by doing right.”