Avandia recall to be reviewed by FDA
The FDA will hold advisory panel meetings next week to review whether there should be an Avandia recall following reports which indicate users of the diabetes drug face a 43% increased risk of heart attacks. Although the FDA is not required to follow the advise of their advisory panels, they usually do.
>>INFORMATION: Avandia side effects
According to documents which FDA staff provided to the committee in advance of the hearing, the current available information demonstrates an increased risk of heart failure, heart attacks and heart related death among type 2 diabetes patients who treat with Avandia (rosiglitazone). The FDA will ask the panel of experts to determine whether there should be an Avandia recall, after they evaluate if the Avandia risks outweigh the benefits over other available treatments.
Problems regarding the Avandia heart attack side effects were reported in an independent meta-analysis published in the New England Journal of Medicine on May 21. The study was performed by Dr. Steven Nissen, a respected cardiologist from the Cleveland Clinic who previously published a report about the problems with Vioxx prior to the athritis drug’s recall in 2004.
The advisory panel could recommend several different actions. Some of the possible options available include an Avandia recall, limitations on who can receive the medication, “black box” warnings about heart attacks, or no actions at all. Regardless, Avandia’s status as one of the best selling drugs in the United States is likely to change and the manufacturer will surely see a sharp drop off in sales from the nearly $3.4 billion generated in 2006.
Since information regarding the heart attack risk was published, many doctors have taken the debate over whether there should be an Avandia recall into their own hands by removing their patients from the medication and recommending safer alternatives.
Immediately following the release of the New England Journal of Medicine study, reports demonstrated that the total number of prescriptions for Avandia fell off by nearly 25%. According to representatives from the drug manufacturer, the number of people taking Avandia dropped by at least 100,000 and new prescriptions fell 40%.
AVANDIA LAWSUITS
The Avandia lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for users of Avandia who suffered a heart attack, stroke, congestive heart failure or death. GlaxoSmithKline has been aware of the increased risks associated with their medication, yet they have actively minimized the risk and continue to allow the prescription to be sold without adequate warnings being provided to users.
Some experts have estimated that approximately 100,000 heart attacks and deaths could have been caused by Avandia. Many of these may have been prevented if the company had acted responsibly. If you, a friend or family member believe you may have a claim, request a free claim evaluation.
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