Relistor Injection Kit Sold With Recalled Alcohol Prep Pads
A warning has been issued about potentially contaminated alcohol swabs and pads that were packaged with Relistor, a drug used to treat opioid constipation.
Progenics Pharmaceuticals, Inc. and Pfizer Inc. have issued a Relistor warning because the drug was packaged with Triad alcohol prep pads, which were recalled earlier this month due to the risk of microbial contamination. The manufacturers indicate that there are no problems with the actual drug, but the packaged alcohol prep pads with Relistor should not be used.
The warning affects all Relistor 1 X 7 kits and 1 X 2 starter kits. Relistor sold in single vials or as kits outside of the United States are not affected, as they were not shipped with Triad alcohol prep pads. The manufacturers have suspended shipping of Relistor until replacements for the alcohol pads can be found.
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Relistor (methylnatrexone bromide) is approved by the FDA to treat opioid-induced constipation (OIC) in patients receiving palliative care due to advanced illness.
Earlier this month the FDA announced a Triad Group alcohol prep pad recall that affected pads, alcohol swabs and swabsticks, due to the risk of potential contamination. The prep pads, swabs and swabsticks were sold together with several medications and individually under a variety of labels, including CVS and Walgreens brands.
In addition to Relistor, the contaminated pads have been packaged together with Betaseron and several Genentech medications, including Boniva injections, Fuzeon, the Nutropin A.Q. Pen, Pegasys and TNKase. In all of the cases, the swabs were packaged with the drugs and the drugs themselves are not believed to be contaminated.
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.
Progenics and Pfizer advise patients not to use the alcohol pads shipped with the drug. They recommend that Relistor patients use an alcohol prep pad from a company other than Triad, or use a sterile gauze pad with isopropyl alcohol. Patients with questions should contact Pfizer Medical Information at 1-800-438-1985.
UPDATE 1/26/2011 2:20 p.m. An earlier version of this article suggested that there has been a Relistor recall. There has not been a recall for Relistor, but rather for the alcohol prep pads that were packaged together with the medication in some kits.
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