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5/13/2002

Ziagen Bottles Found With Combivir Labels

Cheryl A. Thompson

Four bottles containing Ziagen tablets have been found with counterfeit or suspect labels for Combivir tablets, GlaxoSmithKline announced late Friday afternoon.

The company indicated in a press release that no injury or adverse reaction from the "third-party tampering" with the abacavir product had been reported so far. According to the firm, the primary risk to a patient who ingests Ziagen instead of Combivir, which contains lamivudine and zidovudine, is the development of a potentially life-threatening hypersensitivity reaction to abacavir. The labeling for Ziagen includes a boxed warning about the possibility of a fatal hypersensitivity reaction from abacavir exposure and a statement indicating that this adverse event occurs in about 5 percent of patients who receive abacavir therapy.

Ziagen tablets are yellow, shaped like a capsule, and engraved with "GX 623" on one side. Combivir tablets are white, shaped like a capsule, and engraved with "GX FC3" on one side. Both products, which are antivirals used in the treatment of human immunodeficiency virus infection, are available in 60-count bottles, sufficient for 30 days of therapy.

GlaxoSmithKline advised patients to immediately contact their pharmacist if they have a concern about their antiviral medication. Pharmacists who have a bottle of Ziagen with a Combivir-label look-alike should contact the company at 888-825-5249.