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 fosamprenavir calcium |
| Lexiva |
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Pharmaceutical
company:
GlaxoSmithKline
www.gsk.com |
NEW WARNING
GlaxoSmithKline issued a "Dear Health Care Professional" letter after data presented at the 16th Conference on Retroviruses and Opportunistic Infections revealed a possible link between fosamprenavir calcium (Lexiva) and MI in HIV-infected adults. As a result, GlaxoSmithKline has added MI and hypercholesterolemia to the prescribing information's "Adverse Reactions" section and modified the "Warnings and Precautions" section to warn about increases in cholesterol levels that have occurred with treatment. Triglyceride and cholesterol levels should be monitored before and during therapy. Other modifiable risk factors, such as hypertension, diabetes, and smoking should be monitored and treated appropriately. Fosamprenavir is an HIV protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Report adverse reactions associated with use of fosamprenavir to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online, by phone at 1-800-332-1088, or by mailing the postage-paid FDA form 3500 or faxing it to 1-800-FDA-0178.
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