FDA Launches Investigation To Determine Possible Link in Three Cases of Prescription Drug Counterfeiting
Three incidents this month involving tampering with or counterfeiting brand-name drugs has led the FDA to open an investigation to determine any possible connection between the cases, the Wall Street Journal reports. The incidents appear unrelated -- a different method of tampering was used in each case -- and no patients have been reported harmed. But Larry Sasich of Public Citizen's Health Research Group called the string of tampering and counterfeiting "unprecedented." The FDA said it "routinely" looks at tampering or counterfeiting cases to explore possible connections and that the drug makers involved also were continuing to investigate (Adams, Wall Street Journal, 5/14). Here's a quick look at the three drugs under investigation:
- Epogen: Counterfeit vials of the anemia drug, which is made by Amgen and used by dialysis patients, were found in a batch of 10-pack boxes containing 40,000 units of the drug. Although the counterfeit drugs contain Epogen's active ingredient, the concentration is about 20 times lower than the proper medication (Agovino, AP/Los Angeles Times, 5/14).
- Zyprexa: Bottles of the schizophrenia treatment, made by Eli Lilly, were found to contain aspirin. One bottle was found in Minnesota and two in Wisconsin (Wall Street Journal, 5/14).
- Ziagen: At least four sealed bottles of the AIDS medication, made by GlaxoSmithKline, were improperly labeled and sold as Combivir. Mislabeled bottles were found in California, Connecticut, Maryland and Florida by patients and pharmacists who noticed that the pills looked different (California Healthline, 5/13).
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