Alerts
Abacavir Sulfate (Ziagen) and Lamivudine/Zidovudine (Combivir) - Third Party Tampering
April 11, 2007
GlaxoSmithKline issued a notice that abacavir sulfate (Ziagen) tablets were labeled as lamivudine/zidovudine (Combivir) with a counterfeit label. The incident appears to be isolated to one pharmacy in California. Both medications are used for the treatment of HIV. Two misbranded Combivir bottles contained Ziagen 300 mg tablets. The lot number on the bottles was 6ZP9760 and the expiration dates were April 2009 and April 2010. No injuries have been reported due to the misbranding. Examine supplies of Combivir, if bottles contain anything besides Combivir, contact GSK Response Center, 1-888-825-5249. Possible concerns of the mix up are that 8% of patients who take Ziagen have developed a potentially life threatening hypersensitivity reaction and should not take Ziagen again. Also treatment of HIV infection may be interrupted.
Combivir tablets are white and marked GX GC3. Ziagen tablets are yellow and marked GX 623. For pictures of the tablets see the letter from the GlaxoSmithKline link below.
- MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152987.htm - Letter from GlaxoSmithKline:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/UCM154193.pdf
Updated
April 11, 2007; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
