Fake, mislabeled drugs hit four drug makers

Drug Store News, June 17, 2002

NEW YORK - At least four prescription drug products were the subject of tampering or counterfeiting last month, putting the Food and Drug Administration, pharmacists and patients on alert.

Counterfeit Serostim (somatropin rDNA origin injection) was distributed last month to look like the real thing. While drug maker Serono thinks the fakes may have been distributed through the Internet, it is still asking pharmacists to make sure their Serostim does not contain lot number S810-1A1, which is a false number. Serostim is a drug prescribed to treat wasting syndrome from diseases such as AIDS.

Amgen's anemia drug Epogen (epoetin alfa) also was the subject of counterfeiting. Bogus vials of the product contain levels of the active ingredient 20 times lower than they should be. The counterfeit Epogen product is labeled as Epogen (Epoetin alfat) 40,000 U/ml vials in 10-pack boxes containing lot number P002970 and an expiration date of July 2003. Pictures of counterfeit labels can be viewed at www.fda.gov/medwatch/SAFETY/2002/epogen.htm#carton.

Several bottles of another AIDS treatment drug, Combivir (lamivudine plus zidovudine), were found to be mislabeled. GlaxoSmithKline reported it received four reports of bottles labeled as Combivir tablets that actually contained another medicine, Ziagen (abacavir sulfate) tablets. The fake Combivir labels were placed on two bottles of Ziagen, and labels on another two bottles were suspicious. Involved in the counterfeit labeling cases were 60-count bottles of Combivir tablets, which contain 150 milligrams of lamivudine and 300 milligrams of zidovudine, and 60-count bottles of 300-milligram tablets of Ziagen. The drugs are not interchangeable, and a mix-up can cause a life-threatening reaction in some patients.

Some bottles of Zyprexa (olanzapine), a schizophrenia and bipolar treatment from Eli Lilly, also were tampered with last month. Some pharmacists found Zyprexa 10 mg and 15 mg bottles filled with white tablets marked "aspirin." Reports were initially confined to 60-count 10 mg and 15 mg bottles of Zyprexa.