FDA reviewers probe health risks associated with diabetes drug Avandia

/// 03/02/2010

The debate into whether or not GlaxoSmithKline’s (GSK) highly scrutinized diabetes drug Avandia does in fact cause a greater number of heart attacks and heart disease to consumers is expected to draw to a close this summer. Drug safety experts as well as endocrinology and metabolic drug specialists are said to review compiled data concerning the highly publicized safety issues and present them to the U.S. Food and Drug Administration (FDA) Advisory Committee in July 2010, according to information provided by ABC News. Since 1999 when the FDA approved the drug, approximately six million people have taken the drug, annually generating nearly $3 billion.

Dr. Steven Nissen, who was president of the American College of Cardiology in 2007, reportedly announced that based on his evaluation of Avandia (rosiglitazone), consumers were 43 percent more likely to suffer a heart attack and 64 percent more likely to acquire terminal heart disease. Two epidemiologists from the FDA, Dr. David Graham and Dr. Kate Gelperin, were also very critical of the product, noting that “Avandia is responsible for about 500 additional heart attacks and 300 additional cases of heart failure each month than would occur if Actos were used exclusively”. Actos (pioglitazone) is a competitor drug used by diabetic consumers.

Though Avandia reportedly generates the same results as Actos with regard to helping diabetic patients manage their blood sugar levels, Avandia could have seemingly been held liable for what the Senate Finance Committee referred to as a “substantial excess number” of heart attacks and heart failure cases. The report also stated that these heart attacks and heart failures could have been avoided had the consumers used Actos instead.

The Senate Finance Committee also wrote a letter to the FDA Commissioner, Margaret Hamburg, in which the committee contended GSK was aware of the health risks associated with Avandia but withheld such vital information from the public. GSK on the other hand, stated such allegations were contradictory to the “rigorous scientific evidence supporting the safety of the drug”. Reviews of all collected data and evidence are underway.

Mary Alexander, a leading San Francisco pharmaceutical injury attorney, states if you or someone you love has suffered a heart attack or heart disease due to uninformed risks associated with Avandia, you may be entitled to compensation for your injuries and damages. Contacting a seasoned defective drug lawyer who is experienced in litigating these complex claims may help you recover damages you deserve.

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