Topiramate, known as the brand name Topamax, is an anticonvulsant (antiepilepsy) drug. Topamax is used to treat epilepsy in children and adults. In children, it is indicated for the treatment of Lennox-Gastaut syndrome, a disorder that causes seizures and developmental delay. It is also FDA approved for, and most frequently prescribed for, the prevention of migraines.
Topamax is reported to cause serious birth defects for women who were pregnant while using the drug. If you or a loved one is taking Topamax, please read on for facts about the product and the litigation surrounding it.
Facts about Topamax:
- On March 4, 2011 the FDA required the manufacturers of Topamax to significantly strengthen warnings for the drug because of increasing data linking the product to certain types of birth defects including cleft lip, cleft palate, and genital malformations including Hypospadias.
- Topamax was previously classified by the Food and Drug Administration as a Pregnancy Category C drug, which means that data from animal studies suggested potential Topamax side effects for the fetus, but no adequate data from human clinical trials or studies were available at the time of FDA approval. However, because of recent human data that reveal 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 any potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite Topamax cleft palate risks.
- 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 Federal government approval. Also, there was no data from any well-controlled clinical trial to demonstrate that Topamax was safe and/or effective to treat any psychiatric conditions at all.
If you or a loved one has taken, or is taking Topamax and has a child that suffers from a cleft palate or other serious birth defect, find out how Johnson//Becker PLLC can help you. Fill out our case review form here on our website and submit it for a free consultation.