FDA, European regulators restrict Avandia use

Sep 27 2010

Wall Street Journal: "The Food and Drug Administration and European regulators said they were taking action on Avandia, made by GlaxoSmithKline PLC, because of data tying it to increased risk of heart attacks. The FDA move marks a tougher stance by the agency's leadership, named last year by President Barack Obama, and signals to pharmaceutical makers and patients that mass-market drugs with troublesome side effects are getting closer scrutiny" (Mundy, Dooren and Whalen, 9/24). 

Wall Street Journal, in a separate story: "Several doctors who specialize in diabetes said the Food and Drug Administration's decision Thursday to restrict use of the diabetes drug Avandia wouldn't affect their patient care, because they had already been prescribing other medicines" (Rockoff, 9/23).

Los Angeles Times: "Patients who are now taking the drug will have to sign an informed consent statement acknowledging that they understand all the risks before they will be allowed to refill their prescriptions. New patients will not be able to receive the drug unless their doctors certify that they are unable to control their blood sugar levels with other therapies and that medical problems preclude them from taking Avandia's primary competitor, Actos." The European Medicines Agency announced its intent to suspend marketing of Avandia throughout the European Union. "In both cases, the new rules will not take effect for several months."

Avandia has been at the center of a fierce debate since 2007 when "Cleveland Clinic cardiologist Steven Nissen published a study ... suggesting there was as much as a 40 percent increase in risk of cardiovascular disease, heart attack, stroke and death among users" (Maugh and Zajac, 9/23).

The Hill's Healthwatch: "Senate Finance Committee Chair Max Baucus (D-Mont.), who along with ranking member Charles Grassley (R-Iowa) led a two-year inquiry into the drug, applauded the decision. … The consumer group Public Citizen wasn't satisfied. 'By failing to ban the dangerous diabetes drug, Avandia, generic name rosiglitazone, the Food and Drug Administration (FDA) again caved to industry pressure,' Health Research Group Director Sidney Wolfe said in a statement" (Pecquet, 9/23).