A look at the counterfeit drugs
Here is information on some of the recent drug counterfeit cases:
• Olanzapine replaced with tablets marked "aspirin."
On May 4, Eli Lilly notified health care professionals that pharmacists in the United States had found 10 mg and 15 mg bottles of olanzapine (Zyprexa) in which all of the olanzapine tablets had been removed and replaced with white tablets marked "aspirin." Olanzapine is indicated for the treatment of schizophrenia and acute bipolar mania.
The reports have been confined to 60-count 10 mg and 15 mg bottles of olanzapine. Olanzapine 10 mg tablets are round and white, similar to aspirin; however, they are clearly marked in blue with the word "Lilly" and the number "4117" on one side, and no markings on the other side. Olanzapine 15 mg tablets are oval-shaped and blue and are embossed with the word "Lilly" and the number "4415."
• The incorrect labeling of abacavir sulfate (Ziagen) tablets as lamivudine plus zidovudine (Combivir) tablets.
On May 10, GlaxoSmithKline (GSK) announced that it had received four reports of suspect bottles with 60-count lamivudine plus zidovudine tablet labeling that actually contained abacavir sulfate tablets. GSK has determined that counterfeit labels for lamivudine plus zidovudine tablets were placed on two bottles of abacavir sulfate and that labels on another two bottles are suspect. Both medicines are used as part of combination regimens to treat HIV infection.
Involved in the counterfeit labeling cases were 60-count bottles of lamivudine plus zidovudine tablets, which contain 150 mg of lamivudine and 300 mg of zidovudine, and 60-count bottles of 300 mg tablets of abacavir sulfate.
This instance of counterfeiting imparts a complex risk profile since approximately 5% of individuals who receive abacavir sulfate develop a potentially life-threatening hypersensitivity reaction. In addition, the replacement of lamivudine plus zidovudine, which contains two antiviral drugs, with abacavir sulfate, a single antiviral, may decrease the effectiveness of a patient’s treatment regimen.
GSK says pharmacists can easily distinguish the two medications. The lamivudine plus zidovudine tablet is a white capsule-shaped tablet engraved with "GX FC3" on one side; the other side is plain. Abacavir sulfate is a yellow capsule-shaped tablet engraved with "GX 623" on one face; the other side is plain. The Combivir label shows a color photo of the tablet.
• A counterfeit lot of somatropin (rDNA origin) for injection (Serostim).
On May 16, Serono announced the discovery of a counterfeit lot of somatropin (rDNA origin) for injection (Serostim). The counterfeit material had been packaged to appear as drug product lot number S810-1A1, which is not a legitimate somatropin lot number. Preliminary information appears to indicate that the counterfeit material may have been distributed via the Internet.
Somatropin (rDNA origin) for injection is approved in the United States for the treatment of AIDS wasting.
• Counterfeit epoetin alfa product.
On May 8, Amgen announced the existence of a counterfeit drug product labeled as epoetin alfa (Epogen) 40,000 U/mL vials in 10-pack boxes, lot number P002970 and expiration 07/03. The counterfeit vials examined by Amgen held a clear liquid that contained the drug’s active ingredient. However, the concentration of the active ingredient was approximately 20 times lower than expected for epoetin alfa’s 40,000 U/mL vials.
On the counterfeit product, the Amgen logo on the carton closure label on the exterior of the box remained blue when viewed at different heights. The authentic logo shifts from blue to purple. Also, the degree sign is missing from the storage temperature on the counterfeit vial label.
On June 5, Amgen identified two additional counterfeit lots of epoetin alfa. The affected lots are P001091, with an expiration date of 09/02, and P001486, with an expiration date of 12/02.
Epoetin alfa is primarily used for the treatment of anemia associated with chronic renal failure in patients on dialysis.
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