FDA Warns of HIV Drug Tampering

April 11, 2007 -- The FDA today warned that certain bottles of the HIV drug Combivir may actually contain Ziagen, another HIV drug.

Certain Ziagen bottles were apparently tampered with by a third party and misbranded as Combivir with counterfeit labels, say the FDA and GlaxoSmithKline, which makes Ziagen and Combivir.

Some patients may develop potentially life-threatening hypersensitivity reactions to Ziagen's active ingredient.

No injuries or adverse reactions have been reported from the tampering, says GlaxoSmithKline in a letter to pharmacists.

Combivir tablets are white and engraved with "GX FC3" on one side of the table. Ziagen tablets are yellow and are engraved with "GX 623" on one side of the pill.

The FDA and GlaxoSmithKline say two 60-count misbranded bottles of Combivir tablets contained 300-milligram tablets of Ziagen. The counterfeit labels identified are Lot No. 6ZP9760 with expiration dates of April 2010 and April 2009.

"These incidents appear to be isolated and limited in scope to one pharmacy in California," states GlaxoSmithKline's letter, which is posted on the FDA's web site.

GlaxoSmithKline is working with the FDA to investigate the tampering.

GlaxoSmithKline asks pharmacists who find anything other than Combivir in Combivir bottles to call GlaxoSmithKline at (888) 825-5249 Monday through Friday from 8 a.m. to 8 p.m.