On March 4, 2011, the Food and Drug Administration (FDA) informed OB/GYN doctors and neurologists about new data demonstrating that infants born to women treated with Topamax (generic: topiramate) during pregnancy have an increased risk for developing cleft palate or cleft lip.
Topiramate is an approved medication used to treat patients with epilepsy who have certain types of seizures. Topiramate is also approved for use to prevent migraine headaches, but not to relieve the pain of migraine headaches when they occur.
Topiramate was previously classified as a Pregnancy Category C drug, meaning that data from animal studies suggested potential fetal risks. Unfortunately, adequate data from human clinical trials or studies was not available to the FDA at the time of approval.
Were people taking topiramate essentially guinea pigs or lab rats? Donít you wonder why a drug can be placed in the pharmaceutical marketplace without comparable human data approval?
On May 21, 2010, Ortho-McNeil pled guilty and was fined $6.14 million by the FDA for promoting Topamax to treat psychiatric disorders, without applying for any approval. There was no data from any well-controlled clinical trial to demonstrate that Topamax was safe and effective to treat any psychiatric conditions.
How widespread is topiramate use? From January 2007 through December 2010, approximately 32.3 million topiramate prescriptions were dispensed and approximately 4.3 million patients filled topiramate prescriptions from U.S. outpatient retail pharmacies.
Do you have a Topamax cleft palate lawsuit?