FDA Reports Apparent Combivir Bottle Tampering
On Monday, April 9, 2007, the FDA reported on an isolated incident of apparent label tampering involving counterfeit Combivir (lamivudine/zidovudine) labels. The incident occurred at one pharmacy in California, with no reports of similar incidents elsewhere in the United States.
Specifically, a bottle falsely labeled as Combivir actually contained 300 milligram tablets of Ziagen (abacavir sulfate). In some patients, abacavir sulfate has caused a severe allergic reaction sometimes resulting in death. Patients prescribed Combivir may not be advised about this allergic reaction. Legitimate Combivir bottles contain tablets of 150 milligrams of lamivudine and 300 milligrams of zidovudine. The counterfeit labels have been identified as Lot No. 6ZP9760, with expiration dates of April 2009 and April 2010.
It is recommended that pharmacy professionals and patients closely examine the contents of all Combivir bottles. Combivir is a white, capsule-shaped tablet engraved with "GX FC3" on one side; the other side is plain. Ziagen is a yellow, capsule-shaped tablet engraved with "GX 623" on one face; the other side is plain. The FDA report about this incident includes pictures of Combivir and Ziagen for help distinguishing between the two tablets.
If you discover a Combivir bottle that does not contain Combivir tablets, call the GlaxoSmithKline Response Center at 1-888-825-5249 between 8:00 a.m. and 8:00 p.m. ET, Monday through Friday.
Spanish Study Suggests Darunavir Effective in Reducing Viral Load in Treatment-Experienced Patients
A study published in the April 7, 2007, issue of The Lancet documented findings from a long-term clinical trial on the effectiveness of darunavir, in combination with ritonavir, to treat HIV infected individuals. Preliminary data from this trial was available last year but this article contains results from the completed trial. Darunavir, a protease inhibitor (PI), was approved by the FDA in June 2006 to treat HIV infection in adults. In this study, participants with advanced HIV infection were randomly assigned to receive either darunavir with ritonavir or other standard anti-HIV regimens and evaluated for 48 weeks.
Sixty-one percent of participants in the darunavir/ritonavir group experienced at least a 10-fold decrease in viral load, as compared to 15% in the other treatment group. In addition, 45% of the individuals in the darunavir/ritonavir group achieved undetectable viral loads by the end of the study, as compared to 10% in the other treatment group. Results of this study are promising for individuals with advanced HIV infection--darunavir in combination with ritonavir appears to be highly effective in reducing viral load and boosting the immune system. In contrast to other currently available PIs, darunavir does not appear to cause severe side effects.
More research needs to be done to determine if darunavir is effective in other HIV infected populations, including children and treatment-naive individuals. A number of clinical trials are currently evaluating the safety and effectiveness of darunavir in these and other HIV infected populations.
