Trelstar and MixJect System Warning: Recalled Alcohol Pads Included in Kits

Watson Pharmaceuticals, Inc. is the latest drug maker to announce that one of its medications was shipped with recalled alcohol pads, which may be contaminated and pose a risk of serious and potentially life-threatening infections.

On February 4, a warning was issued by Watson Pharmaceuticals that convenience kits packaged with the prostate cancer drug Trelstar and the MixJect drug delivery system may have included Triad alcohol prep pads, which were recalled last month due to the risk of microbial infection.

The drugs themselves are safe, but Watson warns that consumers should not use the prep pads in the convenience kits. The company has ceased shipping the kits and is looking into options for replacing the recalled alcohol pads. The kits will not be available again until March.

The warnings affect any Triad alcohol prep pads that were included in convenience kits for Trelstar and the MixJect system by Watson Pharmaceuticals. Consumers should not use the prep pads included and should dispose of the entire convenience kit appropriately. Consumers should instead prepare the injection site either by rubbing the area with sterile gauze and isopropyl alcohol or use alcohol pads from another manufacturer that are not affected by the Triad recall.

The Triad Group Alcohol pad recall was originally announced by the FDA on January 6, 2011, after alcohol pads, swabs and swabsticks were found to be contaminated with Bacillus cereus, which could pose a risk of potentially life-threatening infections. The products were sold individually under a variety of labels, including CVS and Walgreen’s brands, as well as together with a number of different medications.

Bacillus cereus is responsible for about two percent of all foodborne illness, according to the U.S. Centers for Disease Control and Prevention (CDC). Illness comes within 24 hours after exposure and can result in a diarrheal illness. Serious illness and permanent injury are very rare.

Earlier this month the FDA issued a reminder to health care professionals stressing that they should exhibit care in using prep pads that are not specifically marked as sterile. The reminder followed warnings associated with a number of other drugs that included the Triad prep pads, including Betaseron, Extavia, Arixtra, Relistor, and several Genentech drugs.

Trelstar belongs to a class of drugs known as gonadotropin-releasing hormone (GnRH) agonists, which are all used to treat prostate cancer. The drugs suppress the production of testosterone, limiting the ability of prostate cancer to grow. Safety concerns over the increased risk of diabetes, heart attacks and strokes led the FDA to launch a safety review of GnRH agonists in May, which is ongoing. 

In October, the FDA issued a drug safety alert for all GnRH agonists, including Trelstar, and announced that it was asking manufacturers to add new label warnings on diabetes and cardiovascular risk.