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LEXIVA® (fosamprenavir calcium)
The U. S. Food and Drug Administration (FDA) announced that the widely prescribed HIV medication Lexiva® causes an increased risk of myocardial infarction (heart attack) in users of the drug. Lexiva®, the brand name for fosamprenavir calcium, is a protease inhibitor that is taken with other HIV medications to keep viral load down and T-cell count up. It is made by pharmaceutical giant, GlaxoSmithKline and Vertex Pharmaceuticals.
Lexiva® was initially approved for market in the U.S. in 2003 for HIV treatment. Various new warnings/side effects have been added to the drug label since 2003. The manufacturer is modifying the existing warnings and precautions statement (Section 5.8 Lipid Elevations) in the prescribing information for Lexiva® Tablets and Oral Suspension to highlight that increases in cholesterol have occurred with treatment. The label already contained a statement that the drug could cause an elevation in triglyceride levels. Elevated triglyceride and cholesterol levels greatly increase the risk of cardiovascular events such as a heart attack.
A Dear Health Care Professional letter (DHCP) has been sent to doctors who prescribe the drug. According to the FDA and various reports, the key message to physicians and users of the drug include:
- A case-control study nested in the French Hospital Database on HIV [FHDH ANRS CO4] has reported an association between exposure to fosamprenavir/ amprenavir and an increased risk of myocardial infarction.
- Myocardial infarction has already been identified as a signal for the protease inhibitor (PI) class in general; the reported association is plausible and may be related to the propensity for this drug class to raise blood lipids [The D:A:D Study Group 2007].
- Prescribers are reminded that HIV infection itself has been associated with lipid disorders and ischaemic heart disease. In other words, HIV patients are already at risk for cardiovascular events; adding Lexiva into the mix now causes an even greater risk to patients.
- Triglyceride and cholesterol levels should be checked prior to initiating therapy with Lexiva® Tablets and Oral Suspension and at periodic intervals during therapy. Appropriate clinical management of lipid disorders should be initiated as required (meaning more drug therapy for patients but the lipid medication itself carries risks.
- Other modifiable risk factors for cardiovascular disease (such as hypertension, diabetes and smoking) should also be monitored in HIV-infected subjects and managed as clinically appropriate.
If you or someone you love were injured after taking Lexiva®, you may be entitled to financial compensation. Please fill out our online form, or call us toll free at 1-888-839-3775 to discuss your rights with one of the experienced defective drug lawyers at our firm.
Evers & Preston, PL
609 West Chase Street
Pensacola, FL 32502-4711
Telephone: 1-850-444-9500 | Toll Free: 1-888-839-3775
