FDA’s rejection of our Avandia ban translates to more harm to patients

Late yesterday, the FDA faxed Public Citizen its letter rejecting our October 30, 2008 petition in which we asked the FDA to ban Avandia (rosiglitazone) because its benefits were greatly outweighed by its multiple risks, including increased heart attacks, heart failure, fractures, vision-threatening macular edema and other serious problems. In September of 2010, the European Medicines Agency (EMA) announced a ban of the drug because of its decision that Avandia’s benefits were clearly outweighed by its risks and that additional restrictions to reduce risk could not be identified*. Subsequently, it has also been banned in New Zealand, India and other countries.

In the year since the EMA announcement, according to health-care analytics experts IMS, there have been approximately 1.1 million prescriptions for Avandia-containing drugs filled in the U.S., thereby ensuring the occurrence of hundreds or more patients suffering heart attacks, and cases of severe heart failure – including many deaths and hospitalizations. All of this from a drug deemed too dangerous to stay on the market in all of Europe and in an increasing number of other countries.

The FDA’s decision not to ban the drug but to limit prescriptions for the drug, so that patients will have allegedly tried other treatments first, is a dangerous and reckless refutation of the precautionary principle that is supposed to guide decisions involving public health.  The evidence shows the drug has no unique clinical benefits but unique risks. Unless the FDA can provide evidence that Americans are more resistant to the life-threatening adverse effects of Avandia than people in Europe and the other countries that have banned the drug, this decision, unlike the wise decision last week concerning Avastin, cannot be described as science-based or rational.

The FDA’s rejection of our petition closely follows the announcement by the manufacturer of rosiglitazone, GSK, that it has agreed to pay $3 billion in civil and criminal penalties including the illegal marketing of this drug.

*From the EMA press release announcing the ban:

“The availability of recent studies has added to the knowledge about rosiglitazone and overall, the accumulated data support an increased cardiovascular risk of rosiglitazone. In view of the restrictions already in place on the use of rosiglitazone, the Committee could not identify additional measures that would reduce the cardiovascular risk.  The Committee therefore concluded that the benefits of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorisation of the medicines.”

Dr. Sidney Wolfe is the director of Public Citizen’s Health Research Group.