Topiramate Side Effects and Topamax Birth Defect Lawsuits
On March 4, 2011, the FDA issued a safety alert recommending that pregnant women or women who might become pregnant not use Topamax (topiramate) because of the risk of side effects and birth defects, including cleft lips and cleft palates:
FDA notified healthcare professionals and patients of an increased risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy. 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.
Topiramate, sold under the brand name “Topamax” (often misspelled “Topomax”), was approved to treat epileptic seizures, but the dangerous medication has been overprescribed to treat migraines and psychiatric conditions. Over the past five years, over four million patients were prescribed Topamax, many under the mistaken belief — shared by physician and patient alike — that the drugs had been tested and proven safe of the risks of any serious birth defects.
In April of 2010, the maker of Topamax, Ortho-McNeil Pharmaceutical, settled a False Claims Act whistleblower case alleging Ortho-McNeil improperly promoted Topamax with a “Doctor-for-a-Day” program in which sales representative systematically misrepresented to health care providers the uses of Topamax, and thereafter plead guilty to illegally promoting Topamax “off-label” as a treatment for psychiatric treatments, and was sentenced a criminal fine of $6.14 million.
New research data shows that Topamax usage during pregnancy makes a baby two-hundred times more likely to develop a birth defect like a cleft palate or a cleft lip than if the mother had not taken any anti-epileptic medication.
Topamax litigation is only in its early stages, with no multi-district litigation (MDL) program yet established and any “bellwether trials” years away.
Nonetheless, because the statute of limitations often begins running when a patient “should have known” they could file a birth defect lawsuit, if you took Topamax during your pregnancy and your child was born with cleft lip or cleft palate birth defect, please contact our dangerous drug class actions lawyers using the form below for a no-fee, confidential consultation.
Read more about Topamax lawsuits at our Topamax Information page.