Fosamprenavir calcium (Lexiva) - MEDWATCH by FDA

Lexiva (fosamprenavir calcium) - Dear Healthcare Professional Letter: Association between Lexiva and myocardial infarction in HIV infected adults

Lexiva (fosamprenavir calcium) - Dear Healthcare Professional Letter
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.
Read the complete MedWatch 2009 Safety summary, including a link to the Dear Healthcare Professional letter, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699.htm

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

[Posted 12/03/2009] 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.

abrir aquí:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM192701.pdf