Safety Alerts & Recalls

What does this mean?

Heart attacks, high cholesterol, and redistribution of body fat have already been identified as possible risks of the protease inhibitor class of medicines and doctors should be aware of these possible complications. Triglyceride and cholesterol levels should be checked prior to starting therapy with Lexiva and at periodic intervals during therapy.

If you take Lexiva, you should regularly review your cardiovascular risk factors with your doctor and seek to adjust modifiable risk factors. If your cholesterol is too high, you may need to begin medicine to help lower your cholesterol as well as make adjustments to your diet and physical activity level. If you have a history of other modifiable risk factors for cardiovascular disease such as high blood pressure, diabetes and smoking, please work with your doctor to make sure these conditions are treated and are under control.

Suppression of viral replication in HIV disease with antiretroviral therapy is very important and you should NOT stop treatment on your own. If you have any questions or concerns about this safety alert, please contact the doctor or other healthcare professional who manages your HIV treatment. All treatment decisions, including changes in your diet and activity level, should be first discussed with the healthcare professionals managing your HIV treatment.

Safety Update to Prescribing Information for Lexiva (Fosamprenavir)

GlaxoSmithKline (GSK) and the FDA have announced a potential link between Lexiva (fosamprenavir) and heart attacks and hypercholesterolemia (high cholesterol and triglycerides) in HIV infected adults. GSK has updated the prescribing information for Lexiva to include this new safety information.

Lexiva is used in the treatment of HIV-infection and belongs to the class of antiretroviral medicines called protease inhibitors.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-12-03
Last Updated: 2009-12-04

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