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Did FDA Know Of Avandia Dangers In 2002?

The consumer advocacy organization Public Citizen claims that the Food and Drug Administration knew about problems associated with the diabetes drug Avandia for nearly five years.

Avandia is linked to a greater risk of heart attack and possibly death, reported a new scientific analysis published online Monday. Pooled results of dozens of studies revealed a 43 percent higher risk of heart attack and a 64 percent greater risk of cardiovascular death, according to the review published by the New England Journal.

Public Citizen sent a letter to the FDA complaining that an internal FDA memo from 2002 indicates that FDA scientists recommended labels for Avandia and Actos, another common diabetes drug, be changed to include a warning that there had been reports of heart failure for patients using the drugs. The group claims that despite the memo, the labels have not been changed.

"The failure of the FDA to act on the recommendations made almost five years ago by its Division of Drug Risk Evaluation is yet another case in which the conclusions of scientists who are engaged in post-market drug safety review are not taken seriously enough or addressed soon enough," said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen in a news release. "As a result, millions of people — to the detriment of their health — are prescribed drugs whose risks are dangerously understated, instead of being prescribed safer, equally or more effective alternative drugs."

The group has called on the FDA to either ban the drugs or include black-box warnings on their labels.

Meanwhile, across the country, people who are taking Avandia are trying to figure out what to do. The American Diabetes Association has fielded 70 calls from patients since Monday's report in the New England Journal of Medicine that Avandia is linked to a significantly higher risk of heart attack and possibly death.

Pat Russo is one of them. She has been taking Avandia for three years, but on Tuesday phoned her doctor when she read news reports that it might raise the risk of heart attack.

"We're taking a wait-and-see approach," said the 60-year-old business manager from Pennsylvania.

For now, Russo's doctor has advised her to stay on the medicine. And she has a checkup scheduled in a few weeks.

Avandia's maker, British-based GlaxoSmithKline PLC, contends the drug is safe and that more rigorous studies did not confirm a higher heart attack risk. Most experts say the actual risk to any single patient does appear to be small but that more studies are needed.

The suggestion of a greater heart risk is especially troubling, though, because two-thirds of diabetics die of heart problems.

More than 6 million people worldwide have taken Avandia since it came on the market in 1999 to treat Type 2, the most common form of diabetes and the one linked with obesity.

About 1 million Americans are currently taking Avandia, which sells between $90 and $170 for a one-month supply. Its U.S. sales topped $2.2 billion last year.

The Gonda Diabetes Center at the University of California, Los Angeles has answered at least 10 calls and individual doctors have received scores of e-mails from patients.

Dr. Andrew Drexler, the center's medical director, routinely prescribes Avandia to his patients and has seen their blood sugar levels stabilize. But Drexler said he will be more cautious about prescribing the drug in light of the potential heart risks raised in the New England Journal analysis co-authored by Cleveland cardiologist Dr. Steven Nissen.

"There's definitely concern and confusion," Drexler said. "We need more information."

On Monday, the American Diabetes Association and two influential heart groups jointly released a statement advising diabetics to talk to their doctors before stopping any medication. The Food and Drug Administration issued a safety alert about the potential risks but did not ask for a recall because of ongoing studies that suggest a contradictory effect.

That has left some patients like Russo in limbo. High blood sugar in diabetics can lead to heart disease, kidney failure, stroke, blindness and amputation. Diet and exercise are recommended to control blood sugar, but medication is often needed too. Russo also worries that if she quits Avandia, she'll experience blurry vision and fatigue that will hamper her lifestyle.

On the other hand, she doesn't want to stay on a drug that could be unsafe.

"You set yourself up for a death sentence," she said.