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Lexiva FDA Alerts

The FDA Alert(s) below may be specifically about Lexiva or relate to a group or class of drugs which include Lexiva (fosamprenavir).

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for fosamprenavir

Lexiva (fosamprenavir calcium) - Dear Healthcare Professional Letter

Dec 3, 2009

Audience: HIV/Infectious Disease healthcare professionals, cardiovascular healthcare professionals

GlaxoSmithKline and FDA notified healthcare professionals of a potential association between Lexiva and myocardial infarction and dyslipidemia in HIV infected adults. GSK has modified the existing Warnings and Precautions section of the Prescribing Information to note that increases in cholesterol have occurred with treatment, the importance of lipids management, and a recommendation that triglyceride and cholesterol testing be performed prior to initiating therapy with LEXIVA and at periodic intervals during therapy. The Dear Healthcare Professional letter also provides key messages, actions required by healthcare professionals and supporting information from a case-control study reported at a February 2009 international HIV conference.

[November 2009]


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