Product News and Recalls

Further Quality Problems Plague Topamax

Topamax, or topiramate, is an anti-seizure drug manufactured by Johnson & Johnson.  It is also prescribed to treat migraines and bi-polar disorder. There have been hundreds of lawsuits claiming the drug causes birth defects. Last month, J&J issued a recall notice for two lots (approximately 57,000 bottles) of Topamax after complaints about an unusual odor.

J&J has already recalled Tylenol and dozens of other over-the-counter medications because of unusual odors, which the company believes comes from contamination by a chemical used to treat wood.  This chemical (known as TBA, an abbreviation for 2,4,6-tribromoanisole), can create a moldy smell if even a drug is only contaminated with a small amount. TBA is also known as a “halogenated anisole compound.”  Some people have reported stomach problems, nausea, and vomiting after taking Tylenol contaminated with TBA.

Although J&J became aware as early as November 2009 of unusual odors in at least one of its products, it did not issue all of the recalls that it should have at the time.  Instead it dragged them out as multiple recalls in 2009, throughout 2010, and into 2011. In fact, since November 2009, J&J has issued at least 12 separate recalls affecting a variety of drugs. Topamax was only recalled due to TBA contamination in mid-April of 2011, almost 18 months after the first TBA-related problems at J&J manufacturing facilities were acknowledged.

Other Topamax side effects are more likely to lead to serious complications. For example, use of Topamax during the first trimester of pregnancy increases the risk of the baby being born with cleft lip, cleft palate, and other oral cleft defects by a factor of 21.

If you or a loved one used Topamax during pregnancy and gave birth to a child with cleft lip, cleft palate or other birth defects, contact Lopez McHugh, LLP for a free legal consultation. You can reach us by calling toll-free at 1-877-703-7070.