FDA panel investigates diabetes drug linked to heart attacks

by Jennifer Johnson

NBC News

Patients who are prescribed the popular diabetes drug Avandia are awaiting news from the FDA on whether the drug will be yanked from the market or come with strong warnings.

The makers of the drug are battling a firestorm after a new study showed the drug greatly increased the risk of heart attack.

Avandia is one of the most widely-prescribed diabetes drugs in the world, but last year, a cardiologist from the Cleveland Clinic studied clinical information from Avandia's makers, GlaxoSmithKline and published his alarming conclusion.

"When we put it all together, put all their 42-studies together, we found a 43-percent higher risk of heart attack in patients who got Avandia compared to those who got other anti-diabetes drugs," explained Dr. Steven Nissen.

Nissen says last summer Glaxo proposed putting a warning label on Avandia, but the FDA didn't think it was strong enough.

Now one of the FDA's own doctors suggested to a panel of experts the drug should be pulled from the market.

"Any drug used for the treatment of diabetes that increases the incident or severity of coronary heart disease in patients with diabetes is unacceptable," said Dr. David Graham.

GlaxoSmithKline says it doesn't think either a warning or a precaution is necessary.

"There is a very significant weight of clinical evidence that suggests that there is no increased risk of Avandia versus other commonly prescribed medicines on the market today," said GlaxoSmithKline's Chris Viehbacher.

The American Diabetes Association says Avandia should still be available.

One former Avandia patient, who no longer needed it, agrees.

"No, I'm  not concerned about the drug, and I'm more interested in the freedom of physicians to prescribe it to help their patients," said Richard Ralston.

Many experts fear that freedom could have deadly consequences.  
 
Watchdog groups have targeted Avandia for years, criticizing the FDA for not taking action,
but many patients are urging the FDA to wait for more studies.