ROCKVILLE, Md -- July 24, 2008 -- The US Food and Drug Administration (FDA) has issued an alert regarding serious, and sometimes fatal, hypersensitivity reactions (HSRs) caused by abacavir (Ziagen) therapy in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701.
Abacavir HSR is a multiorgan syndrome characterised by 2 or more clinical signs or symptoms that can include fever, rash, gastrointestinal symptoms, respiratory symptoms, and constitutional symptoms.
The FDA has reviewed data from 2 studies that support the recommendation for pretherapy screening for the presence of the HLA-B*5701 allele and the selection of alternative therapy in positive subjects.
Genetic tests for HLA-B*5701 are already available, and all patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with abacavir or abacavir-containing medications.
Avoidance of abacavir therapy in HLA-B*5701-positive patients will significantly decrease the risk of developing clinically suspected abacavir HSR. For HLA-B*5701-positive patients, treatment with an abacavir-containing regimen is not recommended and should be considered only under exceptional circumstances when the potential benefit outweighs the risk.
Development of clinically suspected abacavir HSR requires immediate and permanent discontinuation of abacavir therapy in all patients, including patients negative for HLA-B*5701. This new safety information will be reflected in updated product labelling.
For further information issued to healthcare professions by the FDA, please see: http://www.fda.gov/cder/drug/InfoSheets/HCP/abacavirHCP.htm
SOURCE: US Food and Drug Administration
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