FDA informed healthcare professionals that serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701. FDA reviewed data from two studies that support a recommendation for pre-therapy 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 available and all patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with abacavir or abacavir-containing medications. Development of clinically suspected abacavir HSR requires immediate and permanent discontinuation of abacavir therapy in all patients, including patients negative for HLA-B*5701.
Source: http://www.fda.gov/cder/drug/InfoSheets/HCP/abacavirHCP.htm
Showing posts with label Abacavir. Show all posts
Showing posts with label Abacavir. Show all posts
Thursday, July 31, 2008
Friday, March 28, 2008
Abacavir and Didanosine
The FDA issued an Early Communication about recent findings of The Data Collection on Adverse Events of Anti-HIV Drugs Study. Data analyses from this study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking Ziagen (abacavir) or Videx (didanosine) as part of their drug therapy. The study is a large observational study of 33,347 HIV-1 infected patients living in North America, Europe and Australia. Patients in this study are being followed to evaluate the short and long term adverse effects of treatment with anti-HIV drugs. FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. This evaluation may result in the need to revise labeling for the products. Until the FDA’s review is complete, health care professionals should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking.
This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.
Source: http://www.fda.gov/cder/drug/early_comm/abacavir.htm
This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.
Source: http://www.fda.gov/cder/drug/early_comm/abacavir.htm
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