Serious Hypersensitivity Reactions with Abacavir (Ziagen)
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FDA is alerting healthcare professionals that certain patients are more likely to experience serious and potentially fatal hypersensitivity reactions when treated with the antiretroviral drug abacavir. Abacavir is sold under the trade name Ziagen and is part of the combination products Epzicom and Trizivir.
Evidence from two studies indicates that patients with a particular HLA allele, HLA-B*5701, are at increased risk for developing a hypersensitivity reaction if treated with abacavir. Because of this, all patients should be screened for this allele before starting or restarting abacavir therapy, including patients who have taken abacavir without a reaction in the past.
Abacavir is not recommended for patients who carry the HLA-B*5701 allele and should be considered only under exceptional circumstances when the potential benefit outweighs the risk. If a patient develops a hypersensitivity reaction, the drug should be stopped immediately and permanently, whether or not the patient carries the HLA-B*5701 allele.
Additional Information:
FDA MedWatch Safety Alert. Abacavir (marketed as Ziagen) and Abacavir-containing Medications. July 24, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Abacavir