Drug maker Ortho-McNeil, a subsidiary of Johnson & Johnson, has recalled 57,000 bottles of the anti-seizure medication, Topamax, after receiving reports that the drug was defective and had an unusual smell. Two defective shipments of 100-milligram Topamax tablets, made last October and December, were pulled and destroyed after four consumers described an odor that was “uncharacteristic.”
Although the drug company did not identify what caused the smell, the U.S. Food and Drug Administration has posted information that may link it to problems with how the medication is stored in the distribution process. The musky, moldy smell is believed to be attributed to the interaction between fungus and a certain kind of wood preservative used on pallets where medication is often stored.
The FDA says even trace amounts of what is known as TBA (2,4,6-tribromoanisole) contamination are easy for human noses to pick up. Drug side effects caused by the mixture have led some patients to report gastrointestinal problems. Because of health risks, the FDA warns that drug products should not be stored near wood pallets treated with halogenated phenolic preservatives.
Consumers have recently alerted drug makers of the mildew-type smell with other drugs including some over-the-counter medications marketed by McNeil Consumer Healthcare and the prescription drug Lipitor made by Pfizer. Drug companies are trying to prevent future recalls of bad-smelling drugs by preemptively contacting suppliers and advising them on safer ways to store the medication they send them.
Drug companies are heavily regulated by the FDA for consumer protection. In addition to facing government regulation, drug makers can also be held accountable for drug defects in court. Any breach of the design, manufacturing, storing, marketing and sale guidelines that leads to a personal injury can expose a drug maker to product liability lawsuits.
Source: Los Angeles Times, “Odd odor prompts drug recall – again,” Marissa Cevallos, 4/15/2011