Bernstein Liebhard LLP, a New York law firm nationally recognized for its consumer protection and mass tort practices, is currently investigating cases of cleft lip and cleft palate and other serious side effects associated with Topamax (topiramate) use. Topamax is a drug used to treat epilepsy and migraines. It is manufactured and sold by Ortho-McNeil Neurologics, a subsidiary of Johnson & Johnson. It first received approval by the U.S. Food and Drug Administration (“FDA”) in 2004.

In 2008, a study published in Neurology reported that there was a link between Topamax use in pregnant women and birth defects. The study, which was conducted by researchers at the Royal Group of Hospitals in Belfast, Northern Ireland, studied 203 pregnant women who were taking Topamax. Of the 178 babies born, 16 had major birth defects. Four of the babies were born with cleft lips or palates, which is a rate 11 times higher than normal. Additionally, four of the male babies were found to have genital defects, which is a rate 14 times higher than normal.

FDA Safety Alert Regarding Topamax and Birth Defects

On March 4, 2011, the FDA issued a safety alert, warning women of child-bearing age that Topamax use increases the risk of birth defects such as cleft lip and cleft palate. Therefore, the FDA recommended pregnant women consider alternative medications to treat epilepsy that do not carry the same risks to unborn children. Additionally, the FDA raised the drug’s pregnancy category to D, which indicates that the drug has the potential to present significant and unreasonable harm to a human fetus. If you took Topamax or topiramate during pregnancy, and your child has suffered birth defects, you may be eligible to file a Topamax lawsuit [add link to CIL page] seeking compensation for your injuries and reimbursement of your expenses. The experienced lawyers at Bernstein Liebhard LLP are currently offering free and confidential consultations to anyone interested in pursuing a Topamax claim. To learn more about your legal rights and options, visit, a consumer advocacy website offered by Bernstein Liebhard LLP that provides free information about dangerous drugs, medical devices and other consumer products.

For more information about filing a Topamax lawsuit, contact an attorney at Bernstein Liebhard LLP at (877) 779-1414 or at

Bernstein Liebhard LLP
10 East 40th Street
New York, New York 10016

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Contact Information

Felecia L. Stern, Esq.
(877) 779-1414

Published May 6, 2011 by