Even With Restrictions on Avandia, FDA Still Cautious

Washington, DCThe European Medicines Agency EMA) has moved to completely banish type 2 diabetes drug Avandia from shelves in European countries. Meanwhile, the US Food and Drug Administration (FDA) appears to have neither the willingness nor the ultimate power to effect that same decision.


The FDA has instead ordered severe restrictions that ultimately accomplish the same thing, according to Dr. Steven Nissen, respected cardiologist from the Cleveland Clinic and the doctor who essentially blew the whistle on Avandia heart attack three years ago.

"Although the European Medicines Agency went further by actually [suspending] marketing of the drug, both regulatory decisions result in essentially the same outcome—virtually complete elimination of the use of this drug by patients around the world," he said.

A gathering of experts convened by the FDA over the summer focused on various known Avandia side effects, inicluding bone fractures and liver failure. While the panel voted to keep Avandia on the market for the time being, it was hardly a ringing endorsement for the diabetes drug. Many were looking for the kind of restrictions that were eventually delivered.

Those restrictions in the US include a halt to all new prescriptions for Avandia unless blood sugar cannot be effectively controlled by any other drug. Avandia manufacturer GlaxoSmithKline has also halted all promotional and marketing initiatives throughout the globe.

For its part, the FDA maintains that access to Avandia is being restricted out of prudence, according to Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

"We are not withdrawing the drug at this time because there is considerable uncertainty about this signal and whether or not it's valid," she said.

However, there are those who find the FDA stance's curious in light of a more definitive stance taken by the EMA. While Health Canada, the governing watchdog in that country is currently evaluating the status quo, a researcher with Sunnybrook Medical Center in Toronto wonders why the FDA is choosing the option of slowly asphyxiating of Avandia rather than the direct kill that the EMA mandated.

"I think what the FDA has effectively done is allow this drug to die a slow, painful death rather than putting it out of its misery more quickly," said Dr. David Juurlink of Sunnybrook, in comments carried 9/23/10 by CBC News. "And in the process, they have allowed large numbers of people to continue to use it, and I think that that's difficult to justify."

The EMA said on September 23 that it was completely halting sales of Avandia in Europe by pulling its authorization for selling Avandia. It is unclear if the FDA has the same authority to do the same.

Other countries have taken a lead in the banning of potentially hazardous drugs in the past. Two years ago the health authority in Germany ordered a halt to all sales of Trasylol, and a Canadian clinical trial was halted due to deaths among trial participants, before Trasylol manufacturer Bayer voluntarily discontinued the drug. The FDA agreed with Bayer's position, but appeared unable to affect that decision on its own.

Nonetheless, Avandia death may become less of a factor, with such active restrictions—if not an outright removal—in place.