FDA Strengthens Topamax Warning As Medication May Cause Oral Birth Defects

Share Article

Thomas J. Henry Injury Attorneys urge mothers who have used Topamax, or its generic topiramate, to contact an attorney as soon as possible if their child was born with any of the following birth defects: cleft lip and/or cleft palate. The FDA has issued a safety announcement due to new data from NAAED indicating that expecting mothers who take the drug are around 20 times more likely to give birth to infants with cleft lips or cleft palate deformities than those who are not treated.

Since 1995, Topamax, manufactured by Ortho-McNeil-Janssen Pharmaceuticals, Inc., has been available worldwide for the treatment of epilepsy. The drug was also granted approval by the FDA to prevent migraines in August of 2004 and its generic form was approved by the FDA in April of 2009. More than 4 million patients have been treated with Topamax for migraines and epilepsy.

Today, March 4, 2011, the FDA strengthened the warning for patients using Topamax and its generic topiramate. Studies show that Topamax significantly increases oral birth defects, including cleft lip and/or cleft palate, in children whose mothers took Topamax during their pregnancy. In fact, this new data shows that expecting mothers who take the drug are 21.3 times more likely to give birth to infants with an oral birth defect such as cleft lips or palates compared to the risk in a background population of untreated women.

The FDA has sent out a notice to medical providers to warn their female patients about the risks of taking Topamax and to discuss alternative medications that have a lower risk of birth defects. Many developmental issues may occur in infants born with cleft palates or lips because they are not able to get adequate nutrition.

Thomas J. Henry Injury Attorneys are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively.

Our attorneys are available 24/7, nights and weekends.

# # #

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Visit website