Counterfeit Drugs: Check Combivir, Serostim, Epogen

Since May 10, pharmaceutical manufacturers and the FDA have been warning medical professionals and patients about wrongly labeled or counterfeit drugs.

• Combivir: On May 10, GlaxoSmithKline announced that it had received four reports of bottles labeled as containing 60 tablets of Combivir (AZT plus 3TC) which actually contained another antiretroviral, Ziagen® (abacavir); the FDA also sent warnings. The main concern was that about 5% of patients receiving abacavir develop a hypersensitivity reaction, which could be life-threatening if not handled correctly. If patients and their physician did not know they were taking the drug, they would not be advised to be on guard for the reaction.

  In this case, the Ziagen itself was the legitimate product.

  From the Glaxo press release of May 10:

  "Pharmacists, physicians and patients should immediately examine the contents of each Combivir® bottle to confirm they do not contain Ziagen® tablets. The two kinds of tablets are easily distinguishable. Combivir® is a white capsule-shaped tablet engraved with "GX FC3" on one side; the other side of the tablet is plain. Ziagen® is a yellow capsule-shaped tablet engraved with "GX 623" on one face; the other side is plain. The Combivir® label [meaning the prescribing information for physicians, not the label on the bottle -- JSJ] shows a color photo of the tablet."

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  Pharmacists and patients who find the mislabeled medicine can call Glaxo at 888-825-5249.

• Serostim: On May 17 Serono, Inc. and the FDA announced that a counterfeit lot of Serostim, the company's human growth hormone, had been distributed. The drug had a fictitious lot number, MNH605A. "Any product labeled as Serostim® and carrying this lot number should be considered to be counterfeit." We have no information about what is in the counterfeit drug, except that it is definitely not the company's product. Patients or physicians who have questions can call Serono at 1-888-275-7376.

• Epogen: On May 21 we received a notice from the FDA that counterfeit Epogen (epoetin alpha) had been distributed. The counterfeit contains active ingredient, but in a concentration about 20 times too low. It is packed as EPOGEN 40,000 U/mL vials in ten-pack boxes, lot number P002970 expiration date: 7/03. More information is available at: http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#epogen.

Comment

From the information we have seen (summarized above), the Ziagen falsely labeled as Combivir may be a result of somebody's incompetence or negligence; it makes less sense as a criminal design. Why use an expensive substitute that is easily distinguishable? In the other cases, fake drugs and labels were deliberately prepared and distributed.

It is not clear from the public information whether any of the mislabeled or counterfeit drugs got into the legitimate distribution chain (meaning that anyone's medicine could be at risk) -- or whether they were ordered from unknown Web sites that could have been set up by anybody. It should be possible to protect the legitimate drugs, since distributors and pharmacies are dealing with well-known suppliers, and the source of each unit could be traced. There are indications that at least some of the bad products may have been bought on the Internet from unknown sites, although the public at least does not know for sure. (See "Clusters of Counterfeit Drugs" by Tim Kingston, San Francisco Frontiers, May 30, 2002; you can request a copy by e-mail from the author at sfnews@frontiersweb.com.)

This is the latest of several incidents of counterfeiting of drugs often used in AIDS treatment. Activists should follow up on the investigations to find out what is learned about where the problems are coming from. We need to know whether or not there is any risk from the drugs on pharmacy shelves.

ISSN # 1052-4207

Copyright 2002 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.