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FDA issues Abacavir Warning

Posted by Administrator (admin) on Jul 29 2008 at 5:04 PM
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FDA has issued a warning about severe, sometimes deadly, reactions caused by the drug Abacavir in some patients. The reactions are known as hypersensitivity reactions or HSRs. Abacavir can cause HSRs in patients who test positive for a particular human leukocyte antigen (HLA) allele called HLA-B*5701. Allele is a constituent in the gene.

Abacavir is a nucleoside analog reverse transcriptase inhibitor (NRTI) used to treat HIV and AIDS. It is available under the trade name Ziagen (manufactured by GlaxoSmithKline) and in the combination formulations Trizivir (abacavir, zidovudine and lamivudine) and Kivexa/Epzicom (abacavir and lamivudine). The adverse reaction called Abacavir HSR is a multi-organ condition that is typified and diagnosed by fever, rash, gastrointestinal reactions-nausea, vomiting, diarrhea, or abdominal pain-respiratory reactions-dyspnea, cough or pharyngitis-and constitutional symptoms-generalized malaise, fatigue, or myalgia.  These HSRs are severe and can sometimes be deadly. If these reactions occur, Abacavir therapy should be discontinued immediately and permanently. Generally, Abacavir HSR develops within first six weeks of initiation of therapy-usually within 11 days once the therapy has started.

FDA reviewed data from two studies and decided to back the recommendation for pretherapy screening for the presence of the HLA connected to the Abacavir reactions. Studies show that 61 percent of patients carrying the HLA-B*5701 allele will develop a clinically suspected HSR during the course of Abacavir treatment compared to four percent of patients who do not carry the particular allele.  And, patients who formerly took Abacavir and tolerated it can develop Abacavir HSR upon restarting Abacavir-containing therapy; therefore, screening for the allele related to these reactions is recommended before reinitiation of Abacavir in patients of unknown allele status who have tolerated Abacavir earlier.  Furthermore, HLA-B*5701-negative patients can also develop an HSR to Abacavir.


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