Experts Say FDA Advisory Panel Meeting Could Lead to Avandia Recall
GlaxoSmithKline’s already heavily restricted diabetes drug, Avandia, could face a national recall following an upcoming FDA advisory panel meeting scheduled to re-examine the side effects of the once-blockbuster medication. Avandia was subjected to severe restrictions by the FDA in 2010, due to an increased risk of heart attacks among users, and, although many critics called for an Avandia recall at that time, the agency allowed the medication to remain on the market with strict limitations on its availability. If you took the diabetes drug Avandia and you have since suffered a heart attack or another major side effect, contact our reputable attorneys at AMA Law to explore your possible compensation options.
INCREASED RISK OF HEART ATTACKS WITH AVANDIA USE
Avandia (rosiglitazone) is a type 2 diabetes medication that was used by millions of patients before researchers found a connection between the drug and an increased risk of heart problems and heart attacks in 2007. In fact, some reports suggest that as many as 100,000 heart attacks may have been caused by Avandia use, and GlaxoSmithKline has reportedly paid more than $1 billion to resolve Avandia heart attack lawsuits filed on behalf of former users of the drug who claim that inadequate warnings about potential side effects were provided to the public and the medical community.
FDA COMMITTEES TO RE-EVALUATE AVANDIA RISKS
Earlier this month, the FDA announced a joint meeting on June 5 and 6, of the agency’s Endocrinologic and Metabolic Drugs Advisory Committee and its Drug Safety and Risk Management Advisory Committee. The FDA advisory panel will take a second look at the results of a recent clinical trial, which found little risk of heart attack side effects among Avandia users. In the clinical trial, called the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD), researchers reported findings that contradicted other studies suggesting that Avandia use is associated with a high risk of heart attack.
CONTACT OUR EXPERIENCED ATTORNEYS FOR LEGAL HELP
According to experts, the upcoming re-evaluation of RECORD’s results by the FDA is likely to indicate more heart attacks related to Avandia, which could finally push the FDA to recall the potentially dangerous medication. An Avandia recall has already been issued in Europe and several other countries worldwide in response to the risk of heart complications, and a number of consumer advocate groups in the United States have urged the FDA to do the same. If you have experienced a potentially life-threatening side effect, like a heart attack, and you believe Avandia to be the cause, consult our knowledgeable lawyers at AMA Law to discuss your legal options.