The manufacturers of Topamax issued a recall of the drug in April 2011 due to a risk of possible chemical contamination. Reports of an offensive odor in some bottle of Topamax suggested that they may have been contaminated with the chemical TBA.
This recall on Topamax affected about 57,000 bottles that were manufactured between October and December 2010. Although non-toxic, TBA may cause gastrointestinal problems in some individuals. Patients who use Topamax were not advised to take any immediate action, but should return their pills to a pharmacist if they notice an unusual odor.
In March 2011, the FDA warned that women who used Topamax during pregnancy (or its generic version, Topiramate) are 21-times more likely to give birth to a child with oral cleft defects, such as cleft lip and cleft palate. Although the FDA upgraded Topamax to its Pregnancy Category D—drugs with a proven risk of causing birth defects—neither agency or the makers of the drug have announced plans to issue a worldwide Topamax recall.
If you or a loved one used Topamax while pregnant and gave birth to a child with oral cleft defects or other types of birth defects, contact the lawyers at Hissey Kientz, LLP to find out more about your rights. You can reach us by calling toll-free at 1-866-275-4454, or by filling out the free case evaluation form on the right of this page.