About 57,000 bottles of the prescription anti-seizure drug Topamax are being recalled due to customer complaints of an "uncharacteristic odor," said J and J.
The recall affects two lots of Topamax 100 milligrams tablets shipped and distributed between Oct. 19, 2010 and Dec. 28, 2010 in the United States and Puerto Rico. The tablets were made by Johnson & Johnson's Ortho-McNeil Neurologics division, CNN.com reported.
There were four consumer complaints about an odor believed to be caused by trace amounts of the chemical TBA (2,4,6 tribromoanisole), which is applied to wooden pallets used to transport and store packaging materials.
On March 4, 2011, the FDA announced new data suggesting that babies born to women who took Topamax during their first trimester have an increased risk of birth defects.
Birth defects associated with Topamax use include but are not limited to:
- Cleft Lip
- Cleft Palate
- Genital Defects
- Fetal and Skeletal Malformations
A cleft lip or cleft palate occurs when the mouth fails to fully form, causing a split or gap in the roof of the mouth. These deformities may cause developmental issues and can lead to severe ear infections and problems with eating and talking.
