April 2, 2007

GSK Reports Combivir and Ziagen Tampering

GlaxoSmithKline has issued a letter to healthcare providers and community educators regarding apparent third-party tampering that caused misbranding of Ziagen® (abacavir) tablets as Combivir® (lamivudine and zidovudine) tablets and employed counterfeit labels for Combivir tablets. According to the March 29 notice, 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 products. 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 mg of lamivudine and 300 mg of zidovudine; however, the misbranded bottles of Combivir contained 300 mg tablets of Ziagen.  The counterfeit labels identified Lot No. 6ZP9760 with expiration dates of April 2010 and April 2009.   

The risk to patients is primarily due to the fact that approximately 8% of individuals who receive abacavir have developed a potentially life-threatening hypersensitivity reaction.  Symptoms generally resolve after discontinuing the medication; however, patients who have had a hypersensitivity reaction to abacavir-containing products are advised to never take the medication again, due to the risk of rapid and potentially fatal symptoms.

In addition, the replacement of Combivir, which contains two antiviral drugs, with Ziagen, a single antiviral, may decrease the effectiveness of a patient's treatment regimen.

GlaxoSmithKline is encouraging patients who have bottles of Combivir tablets to examine the contents of each bottle to confirm that they indeed contain Combivir tablets. 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:



If any patient discovers 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.

For additional helpful information on how to avoid unsafe medicines and vendors, see a helpful website sponsored by The Partnership for Safe Medicines

Source:

GlaxoSmithKline