Topamax Increases the Risk of Cleft Lip and Cleft Palate
in Babies Exposed to the Drug During Pregnancy

Babies exposed to Topamax during pregnancy are 21 times* more likely to have a cleft lip or cleft palate according to the North American Antiepileptic Drug (NAAED) Pregnancy Registry. If your child was born with a cleft lip or cleft palate and you took Topamax while pregnant, you may be entitled to compensation. Our Topamax lawyers will help you understand your legal rights and provide aggressive representation backed by over 20 years of experience successfully handling cases against major pharmaceutical companies.

Baum Hedlund’s pharmaceutical birth defect attorneys are investigating Topamax-related cleft lip and Topamax cleft palate cases for families throughout the United States. Our firm has successfully represented clients harmed by medications in over 4,000 individual cases.

The FDA issued a Topamax warning on March 4, 2011 informing the public of the new data that show that there is an increased risk for development of cleft lip and/or cleft palate (oral clefts) in newborns born to women treated with topiramate (Topamax and generic products) during pregnancy. Both cleft lip and cleft palate can lead to numerous developmental, psychological and social delays.

Topamax (topiramate) is an antiepileptic drug (AED) made by Ortho-McNeil Pharmaceuticals, a Johnson & Johnson subsidiary. It is approved for the treatment of epilepsy and for the prevention of migraines. Topiramate is also prescribed off-label for unapproved uses, including weight loss and the management of alcohol dependence.

Topiramate was previously classified as a Pregnancy Category C drug, which means that data from animal studies suggested potential fetal risks, but no adequate data from human clinical trials or studies were available at the time of approval. However, because of new human data that show an increased risk for oral clefts, topiramate is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks. The change in pregnancy category will appear in the new prescribing and labeling information of the medication.

If you took Topamax or its generic version during your pregnancy and had a baby with oral clefts, you and your child may be entitled to compensation. It is imperative that you contact an experienced law firm to guide you through the complicated process of filing a claim.

*Data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to topiramate monotherapy during the first trimester of pregnancy. The prevalence of oral clefts was 1.4% compared to a prevalence of 0.38% - 0.55% in infants exposed to other antiepileptic drugs (AEDs), and a prevalence of 0.07 % in infants of mothers without epilepsy or treatment with other AEDs. The relative risk of oral clefts in topiramate-exposed pregnancies in the NAAED Pregnancy Registry was 21.3 as compared to the risk in a background population of untreated women (95% Confidence Interval:7.9 – 57.1). The UK Epilepsy and Pregnancy Register reported a similarly increased prevalence of oral clefts (3.2 %) among infants exposed to topiramate monotherapy, a 16-fold increase in risk compared to the risk in their background population (0.2%)