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The epilepsy and migraine drug Topamax, which is also available as generic topiramate, has been associated with an increased risk of major birth defects. Research has found higher than expected rates of babies born with cleft lips, cleft palates, genital defects and other birth malformations when the drug is used during pregnancy.
TOPAMAX LAWSUIT STATUS: After a string of court losses, the makers of Topamax agreed to settlements for undisclosed amounts in about 76 Topamax birth defect lawsuits.
MANUFACTURER: Topamax is manufactured by Ortho-McNeil Neurologics, a subsidiary of Johnson & Johnson. Generic Topamax versions have been available since 2006.
OVERVIEW: Topamax (generic topiramate) was first introduced as a medication to treat epilepsy, which is a neurological disorder characterized by recurrent, uncontrolled seizures. In 2004, the FDA approved Topamax for an additional use of treating migraines, and it has since become one of the most widely prescribed migraine medications in the United States. The drug is also often prescribed off-label to treat bipolar disorder.
TOPAMAX BIRTH DEFECT SIDE EFFECTS: In March 2011, the FDA issued a warning that Topamax side effects may increase the risk of oral cleft birth defects, such as cleft lip and cleft palate, among babies born to mothers who took the drug during the first trimester of pregnancy. As a result of inadequate warnings previously provided, many women were not aware they may be exposing their baby to a potential risk of Topamax birth defects.
The FDA has urged doctors to avoid giving Topamax to pregnant women or women who are of child-bearing age and at a high risk of pregnancy. Alternative epilepsy drugs may not carry the same risk for the unborn child.
In July 2008, a small study published in the medical journal Neurology identified a potential link between the use of Topamax during pregnancy to an increased risk of serious birth defects. Children born to women who used Topamax during pregnancy were found to develop a cleft lip or palate at a rate 11 times hirer than would be expected in the general population. The study also indicated that children exposed to Topamax developed genital defects at a rate 14 times higher than would be expected.
The FDA required new warnings in 2011 after data from the North American Antiepileptic Drug Pregnancy Registry found that children born to mothers who took Topamax during the first trimester of pregnancy experienced an oral cleft about 1.4% of the time, compared to a prevalence rate of between 0.33% and 0.55% associated with other epilepsy drugs.
TOPAMAX CLEFT LIP AND CLEFT PALATE LAWYERS: Potential lawsuits and class action claims are being reviewed by Topamax lawyers as a result of the drug makers’ failure to adequately research their medication or warn about the potential risk of cleft lip or cleft palate when Topamax is used during pregnancy.