The widely used drugs Avandia and Avandamet significantly increase the heart attack risk for type II diabetes patients according to an alarming report published in the New England Journal of Medicine.
The maker of Avandia (also known as rosiglitazone) is GlaxoSmithKline. The firm’s own study found a 30 percent increased risk of heart attack, and turned the results of it study over to the U.S. Food and Drug Administration. The NEJM report suggests a 43 percent increased risk.
FDA officials issued a safety alert today. Congressman Henry Waxman, chairman of the House Oversight And Government Reform Committee reacted immediately by scheduling a hearing on the FDA’s evaluation of Avandia in considering the drug’s safety, inviting the author of the NEJM study, a representative of GlaxoSmithKline, and FDA Commissioner Andrew von Eschenbach.
The hearing should shed some light on the question of how quickly and effectively the FDA responds when presented with substantial evidence of significant health risks to the public.
Meanwhile, the American Diabetes Association is advising that diabetics should talk to their doctors before stopping any medication. This is clearly a case where the learned intermediary rule (an exception to the manufacturer’s common law duty to warn consumers directly of reasonably foreseeable risks–provided they provide adequate warnings to the prescribing doctors) is going to play a significant role in any injuries or deaths that occur going forward in the wake of the FDA Safety Alert, and doctors who keep their patients on Avandia will probably be called to answer for that judgment call.