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Safety Concerns Prompt Prime to Remove Avandia(R) from Formulary
Date:12/6/2007

ST. PAUL, Minn., Dec. 6 /PRNewswire/ -- Pharmacy benefit manager Prime Therapeutics (Prime) recently announced the removal of the prescription drug Avandia(R) from its national formulary. After careful examination of clinical literature regarding the safety and efficacy of Avandia, Prime's National Pharmacy and Therapeutics (P&T) Committee has made the decision to remove the drug from its formulary. Prime's P&T Committee is a panel of pharmacists and physicians that meets quarterly and reviews drugs for Prime's formulary.

In May 2007, a meta-analysis by Nissen, et al, suggested that Avandia significantly increased the risk of heart attack. The results of this meta-analysis were also duplicated by the Food and Drug Administration (FDA) and Avandia manufacturer, GlaxoSmithKline. Consequently, in November 2007, the FDA announced that a black boxed warning for an increased risk for heart attacks in some patients would be added to Avandia's prescribing information.

Following the May publication of the Avandia meta-analysis, Prime's outcome clinicians began an in-depth analysis of Avandia utilization. An analysis of medical and pharmacy claims revealed that over 25 percent of patients on Avandia had a history of coronary artery disease or heart failure. The clinical evidence indicated that the use of Avandia in these patients may increase cardiovascular risk. Since the meta-analysis was released in May, Prime has seen a 58 percent decline in Avandia utilization.

"Prime has made this decision after a thorough analysis of the clinical literature examining the safety and efficacy of Avandia. Prime's National P&T Committee is committed to ensuring the safety and quality of Prime's formulary medications," stated Craig Mattson, Prime's Senior Director of Drug Technology Assessment and Formulary Development. "Prime takes drug safety warnings very seriously and our primary concern is the safety of our members."

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SOURCE Prime Therapeutics LLC
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