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Avandia® (Rosiglitazone)
There have been suspicions that the diabetes drug Avandia® (rosiglitazone) has been associated with a greater incidence of heart attacks among those taking Avandia for long periods of time.
The US Food and Drug Administration (FDA) reviewed data from a long-term study regarding the use of the diabetes drug Avandia® (rosiglitazone). The study, nicknamed RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes), was designed to evaluate how safe rosiglitazone (Avandia®) is for patients with Type II Diabetes Mellitus.
The RECORD report, released last weekend by the Committee on Finance Chair, Senator Max Baucus and ranking member Senator Chuck Grassley, concludes that there are “serious health risks associated with Avandia.” It states that GlaxoSmithKline failed to disclose the cardiovascular risks to clinicians and patients. The report includes more than 250,000 pages of documents provided by the company, the FDA, and several research institutes, as well as interviews with numerous people at GlasxoSmithKline, the FDA and “anonymous whistleblowers.”
In response to the RECORD study, the FDA announced FDA Avandia Safety Announcement on February 22, 2010 the possible cardiovascular risks with the use of Avandia® (rosiglitazone). The FDA warned that patients who take Avandia® should be monitored for signs and symptoms of heart failure, including excessive and rapid weight gain, difficulty breathing and/or swelling.
If you or a family member were prescribed Avandia® (rosiglitazone) to treat Type II Diabetes and suffered serious cardiovascular problems, including myocardial infarction (heart attack); heart failure or death, you should immediately seek legal representation from an experienced pharmaceutical lawyer. Please contact us for a free, no obligation, confidential consultation by calling 1-800-642-5297, or by submitting the contact form below: