Wednesday, May 23, 2007

Patients weigh options amid Avandia risk

By ALICIA CHANG, AP Science WriterTue May 22, 5:32 PM ET
Pat Russo tried different drugs to control her diabetes before settling on Avandia, a widely prescribed diabetes pill now under scrutiny. She has taken it 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.
Across the country, people with Type 2 diabetes like Russo are calling their doctors. 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.
Avandia 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.

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