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U.S. Department of Health and Human Services

For Consumers

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Product Tampering that Incorrectly Labels Ziagen as Combivir

5/15/2002

GlaxoSmithKline has received four reports of suspect bottles containing 60 tablets of Combivir (lamivudine plus zidovudine) that actually contained another medicine, Ziagen (abacavir sulfate) Tablets. The company has determined that counterfeit labels for Combivir Tablets were placed on two bottles of Ziagen and labels on another two bottles are suspect. Both medicines are used as part of combination regimens to treat HIV infection.

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 risk to patients is primarily due to the fact that approximately 5% of individuals who receive abacavir sulfate in Ziagenâ or Trizivirâ (abacavir sulfate, lamivudine and zidovudine) Tablets have developed a potentially life-threatening hypersensitivity reaction. Symptoms generally resolve after discontinuing the medication, however, patients who have had a hypersensitivity reaction to Ziagenâ are advised to never take the medication again. Patients taking Combivirâ would not have been advised about the hypersensitivity reaction and how to take Ziagenâ safely because Combivirâ does not contain abacavir sulfate. Patients who have had a hypersensitivity reaction to abacavir yet take Ziagenâ or Trizivirâ again experience more severe symptoms within hours that may include life-threatening hypotension (lowering of the blood pressure) and death. In addition, the replacement of Combivirâ which contains two antiviral drugs with Ziagenâ , a single antiviral, may decrease the effectiveness of a patient's treatment regimen.


Read the MedWatch 2002 Safety Information Summary including links to the GlaxoSmithKline press release at:
http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#comb

Richard Klein
Office of Special Health Issues
Food and Drug Administration