Topamax® Cleft Lip And Cleft Palate

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 birth defect 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.

In early March 2011, the Food and Drug Administration (FDA) announced that Topamax (topiramate), along with its generic versions, increased the risk for cleft lip and cleft palate (oral clefts) in children whose mothers took topiramate while pregnant.

Oral clefts are birth defects that affect the upper lip and the roof of the mouth. 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.

The FDA’s advisory was based on recent scientific data that indicated that topiramate is 21 times* more likely to cause craniofacial oral clefts in babies born to women treated with topiramate during their pregnancy.

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.

A study dating back to 2008 also found an increased risk associated with the use of topiramate during pregnancy and congenital defects. It was not until the FDA required a label change that the makers of Topamax added this information.

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.

Baum, Hedlund, Aristei & Goldman, has handled hundreds of pharmaceutical-induced birth defect cases for families all across the country. Baum Hedlund attorneys have over 20 years experience litigating product liability cases against major pharmaceutical manufacturers. The firm has been on the prevailing side of some of the nation's most highly-publicized cases. Such litigation involves complex evidence and choice of law issues which have been routinely handled by the firm in both state and federal courts.

In all, Baum, Hedlund has successfully represented clients harmed by prescription medications in over 4,000 individual cases, in addition to representing consumers in multiple pharmaceutical class actions. The firm has offices in Los Angeles, Philadelphia, and Washington, D.C., and is listed in the Bar Register of Preeminent Lawyers and is able to communicate in Spanish, German and Farsi.

*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%).