Fifty-seven thousand bottles of Topamax® anti-seizure medication have been recalled by Johnson & Johnson (J&J) because of consumer reports of a foul odor.
Four customers reported the odor, which was traced to small amounts of TBA (2,4,6 tribromoanisole), the chemical derivative of a substance for preserving the wood of pallets used to store and transport products, according to J&J. The company said TBA is not toxic and no harm has come to any Topamax® users as a result of chemical exposure.
But, the smell is supposed to be very offensive and so powerful that just a tiny amount can be smelled.
Ortho-McNeil Neurologics, the maker of Topamax® and a J&J company, said the product was sent to stores in the United States and Puerto Rico. The company said it believes less than 6,000 bottles of the foul-smelling medication are still on the market. A Gurabo, Puerto Rican, facility of J&J made the Topamax®.
Topamax®, taken to treat certain types of seizures and to prevent migraines, was recently blamed by the U.S. Food and Drug Administration (FDA) for potentially causing birth defects in babies born to pregnant women taking the drug. The birth defects, cleft lips and cleft palates, are the most common birth defects of the face and head.
After reviewing the data of the North American Antiepileptic Drug Pregnancy Registry, the FDA sent out the safety warning about the drug when taken by pregnant women. The U.S. registry found that 1.4 percent of babies with oral clefts were born to epileptic patients on the medication. Statistics from the United Kingdom support the U.S. numbers.
The current recall follows a recall in July 2010 of 21 lots of Ortho-McNeil products of some lots of Benadryl®, Tylenol® and Motrin® due to moldy or musty odors. The medicines had been shipped to the U.S., Fiji, Guatemala, the Dominican Republic, Puerto Rico, Trinidad and Tobago and Jamaica. These products had been shipped and stored on the same type of wooden pallets as the Topamax®.
An FDA press release announcing the previous recall said the risk of serious adverse medical events is remote.
