Safety Alerts & Recalls

What does this mean?

Hypersensitivity reactions (HSR) caused by abacavir therapy are more common in patients with a specific gene called HLA-B*5701. This alert reinforces the importance of testing for this gene prior to starting or re-starting therapy - the test is already commonly available. If you test positive for this gene, treatment with an abacavir-containing regimen is not recommended and should be considered only under exceptional situations when the potential benefit outweighs the risk.

If you are already are taking abacavir, this alert is a reminder to watch for signs of abacavir hypersensitivity reaction - such as fever, rash, gastrointestinal symptoms, and breathing problems. If you develop these symptoms, contact your doctor immediately.

Genetic testing recommended before starting abacavir-containing products

Today, the FDA recommended that patients starting new treatment or re-treatment with abacavir should be screened for the presence of the gene associated with serious hypersensitivity reactions (HSR) caused by abacavir therapy.

more information here

Source: FDA
Publication Date: 2008-07-24
Last Updated: 2009-12-06

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