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Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.


July 2013

Sidney M. Wolfe, M.D.

The diabetes drug rosiglitazone (Avandia) was removed from the European market in 2010 by the European Medicines Agency (EMA) due to the cardiovascular risks the drug posed. So why is it that thousands of Americans (132,000 since 2010) continued to be prescribed the dangerous medication, likely resulting in hundreds or more serious, even fatal, adverse reactions, including heart failure and heart attacks?

The “reason,” if it can be called reasonable, was that although both authorities had access to the same safety studies, the Food and Drug Administration (FDA) and the EMA reached very different conclusions in September 2010 regarding the fate of this once top-selling diabetes drug. The EMA concluded that new data support the drug’s posing an increased cardiovascular risk. Since that agency “could not identify additional measures that would reduce the cardiovascular risk,” they “concluded that the benefits of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorisation of the medicine.” Furthermore, the EMA was so concerned about Avandia’s dangers that when it banned the drug, it stated that the only way it could ever be marketed again was if the manufacturer could “provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks.”

After a July 2010 advisory committee meeting, the FDA, in contrast, decided not to ban the drug but to institute a risk evaluation and management strategy (REMS) to limit the use of the drug to those the agency “believed” could benefit. The patient-reckless conclusion was not to approve a REMS until May 2011. (It was not fully in place until six months later). However, there has never been any evidence that those getting the drug in this country have been patients for whom the benefits of the medicines outweighed their risks.

Once again, instead of banning a drug — as recommended by 12 FDA advisory committee members —because it lacks unique benefits but poses unique risks, the FDA has hidden behind a REMS program that has reduced the number of people using the drug to 2,400 in 2012. Unfortunately, the 132,000 people who used Avandia in the U.S. since 2010 represent hundreds of preventable injuries and deaths.

REMS should be reserved for drugs that need to remain available. By no stretch of the imagination is Avandia such a drug. Ask the EMA. Unfortunately, the FDA is considering relaxing its restrictions. We continue to advise patients not to use this dangerous drug.

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