FDA warns of bacteria-laced fake drug
WASHINGTON (Reuters) -- U.S. regulators warned health officials and consumers Tuesday to be on the lookout for bacteria-tainted fakes of a popular anemia drug made by Johnson & Johnson's Ortho Biotech unit.
U.S. Food and Drug Administration investigators said three lots of fake Procrit, an anemia drug aimed at coaxing production of red blood cells, were tainted with bacteria that make the product a "significant potential hazard to consumers."
Ortho Biotech, in a letter to consumers and health professionals, cited two potential bacteria contaminants in the fakes, which it believes is a clear liquid with no active ingredient meant to simulate the drug.
"It is likely that this material was produced under non-sterile conditions," Mark Klausner, vice president of clinical affairs at Ortho Biotech said in the warning. "The possibility of other contaminants cannot be ruled out at this time."
Ortho Biotech cited subtle differences in the packaging distinguishing authentic versions of Procrit and the copycats.
The company is working with the FDA to uncover the origin of the fakes.
Regulators say production of phony medicines is rising, as counterfeiters become more sophisticated and Americans seek low-cost drugs.
The FDA opened six criminal counterfeiting cases in 1999, 10 cases in 2000 and 23 cases in 2001.
Amgen Inc.'s Epogen has also been counterfeited.
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