{"id":7841,"date":"2010-02-16T12:01:02","date_gmt":"2010-02-16T12:01:02","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=7841"},"modified":"2013-08-06T07:07:57","modified_gmt":"2013-08-06T07:07:57","slug":"gsk-issues-dear-doctor-letter-in-the-us-fosamprenavir-and-cardiovascular-risk","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/7841","title":{"rendered":"GSK issues Dear Doctor letter in the US: fosamprenavir and cardiovascular risk"},"content":{"rendered":"

On 4 December 2009\u00a0GlaxoSmithKline (GSK) and FDA notified healthcare professionals and others of a potential association between fosamprenavir and myocardial infarction\u00a0(heart attack) and dyslipidemia (abnormal concentrations of lipids or lipoproteins in the blood) in HIV-positive adults.<\/strong><\/p>\n

GSK has modified the existing\u00a0warnings and precautions\u0092\u00a0section of the prescribing information to\u00a0note that increases in cholesterol have occurred with treatment, the importance of\u00a0lipids management, and a\u00a0recommendation that triglyceride and cholesterol testing be performed prior to initiating therapy with fosamprenavir and at\u00a0periodic intervals during therapy.<\/p>\n

The text of the Dear Healthcare Provider letter follows:<\/p>\n

Dear Healthcare Professional:<\/strong><\/p>\n

Fosamprenavir calcium (Levixa) tablets and oral suspension: \u00a0myocardial infarction and dyslipidemia\u00a0<\/em><\/p>\n

GlaxoSmithKline would like to inform you of data presented at the 16th Conference on Retroviruses and Opportunistic Infections (CROI 2009) relating to a\u00a0potential association between fosamprenavir tablets and oral suspension and myocardial infarction in HIV infected adults.<\/p>\n

Action being taken by GSK<\/strong><\/p>\n

GSK has added myocardial infarction and hypercholesterolemia to the Adverse Reactions section of the fosamprenavir prescribing information (Section 6.2\u00a0Postmarketing Experience). Elevations in triglyceride levels are already described in the Adverse Reactions section (Section 5.8 Warnings and Precautions,\u00a0Section 6.1 Clinical Trials).<\/p>\n

GSK has modified the existing Warnings and Precautions statement (Section 5.8 Lipid Elevations) in the prescribing information for fosamprenavir Tablets\u00a0and Oral Suspension to highlight that increases in cholesterol have occurred with treatment. This statement highlights the importance of lipids management\u00a0by including a recommendation that triglyceride and cholesterol testing should be performed prior to initiating therapy with fosamprenavir Tablets and\u00a0Oral Suspension and at periodic intervals during therapy. GSK is in communication with FDA and this issue will be closely monitored.<\/p>\n

Key messages<\/strong><\/p>\n