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News Articles >> Part 2: Avandia, the FDA and the consum..
Part 2: Avandia, the FDA and the consumer: first lawsuit filed
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| June 25, 2007. By Brenda Frohloff |
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Beaumont, TX: It is now one month since GlaxoSmithKline's popular diabetes drug Avandia was reported to carry with it a higher risk of heart attack—and just two days ago, on June 19, what is likely the first lawsuit blaming Glaxo for contributing to just such a heart attack, was filed.
Larry Alan Stanford, 60, of Beaumont, Texas, suffered a heart attack and died May 21, ironically the same day the meta-analysis of numerous smaller studies of the effects of taking Avandia, was published in the New England Journal of Medicine.
Stanford's widow, Peggie Stanford, and son, Ryan Stanford, filed the lawsuit against GlaxoSmithKline in the U.S. District Court for the Eastern District of Texas. Stanford had been taking Avandamet, a form of Avandia mixed with another diabetes drug, since early 2005.
GlaxoSmithKline responded to news of the lawsuit through a spokesperson, Alice Hunt, who said the company would vigorously defend its product.
Since the meta-analysis was published there has been uncertainty on the part of physicians and patients as to whether to continue with prescriptions of Avandia. Prescriptions for Avandia plummeted following that publication, and share values in Glaxo fell too. Glaxo was subsequently hit with a lawsuit from its shareholders, who claimed Glaxo had withheld information from the investing public as to the safety of Avandia.
A congressional hearing was held June 6 to look into the handling of information on adverse reactions and risks relating to Avandia. Representatives of both Glaxo and the FDA gave testimony. That same day, the FDA asked Glaxo to put a Black Box warning (highest level of warning) on the Avandia packaging, regarding potentially increased risk of heart attack and heart disease for those taking the drug.
An FDA advisory panel is scheduled to meet July 30 to study the issue of Avandia's safety.
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