Medication Tampering Alert

April 11, 2007

ISSUE:	FDA announces incidences of label tampering and misbranding of Ziagen® as Combivir® and counterfeit labels for Combivir tablets
MEDICATION:	Ziagen® (abacavir) and Combivir® (lamividine and zidovudine), GlaxoSmithKline Pharmaceuticals

The following was posted on the FDA Med Watch alert website dated April 10, 2007:
"GlaxoSmithKline and FDA informed healthcare professionals of an apparent third-party tampering that resulted in the misbranding of Ziagen as Combivir and employed counterfeit labels for Combivir Tablets. Both medications are used as part of combination regimens to treat HIV+ infection. Two 60-count misbranded bottles of Combivir Tablets contained 300 mg tablets of Ziagen. The counterfeit labels identified are Lot No. 6ZP9760 with expiration dates of April 2010 and April 2009. The incident appears to be isolated and limited in scope to one pharmacy in California. Pharmacists should immediately examine the contents of each bottle of Combivir in their pharmacy to confirm that the bottles contain the correct medication. The Dear Pharmacy Professional Letter contains photos of actual Combivir and Ziagen Tablets. If a bottle contains anything other than Combivir Tablets, pharmacists should notify the manufacturer."

An excerpt of the GlaxoSmithKline "Dear Pharmacy Professional" letter states:

"We call to your attention an apparent third-party tampering that caused misbranding of Ziagen® (abacavir sulfate) Tablets as Combivir® (lamivudine and zidovudine) Tablets and employed counterfeit labels for Combivir Tablets. Both Combivir and Ziagen are medicines used as part of combination regimens to treat HIV infection. These incidents appear to be isolated and limited in scope to one pharmacy in California; to date, there have been no reports of similar incidents in other cities or in other states. No injuries or adverse reactions have been reported. Company tests have shown no problems with the medicine itself; both Ziagen and Combivir are authentic drug product. GlaxoSmithKline is working with the U.S. Food and Drug Administration to investigate. Involved in the misbranding cases were two 60-count bottles of Combivir Tablets. Combivir Tablets (in a legitimate bottle) contain 150 milligrams of lamivudine and 300 milligrams of zidovudine; however, the misbranded bottles of Combivir contained 300 milligram tablets of Ziagen. The counterfeit labels identified Lot No. 6ZP9760 with expiration dates of April 2010 and April 2009.

If you have bottles of Combivir Tablets in your pharmacy, you should immediately examine the contents of each bottle of Combivir to confirm that it does indeed contain tablets of Combivir. You may choose to counsel patients who have recently received Combivir. The Combivir and Ziagen 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. Please see the enclosed photos of Combivir and Ziagen.

If you discover a bottle of Combivir that contains anything but Combivir tablets, please notify the GSK Response Center at 1-888-825-5249 (toll free) between 8:00 a.m. and 8:00 p.m. ET, Monday through Friday."