Scientists advising the Food and Drug Administration yesterday recommended that the diabetes drug Avandia continue to be sold in the United States with new warnings to patients that the drug increases the risk of heart attack.
The advisory committee met yesterday to consider whether Avandia should be restricted to select patients and branded with prominent warnings, or be barred from being sold. The panel voted 22-1 in favor of keeping the drug on the market, with a recommendation to bolster the drug’s warning label and conduct additional study.
“I think there are reasons not to use this drug in certain diabetic patients. Now clinicians will have to think twice before prescribing this medicine, and there are other medications out there,” said Dr. Clifford Rosen, acting chairman of the advisory committee. “We have provided a road map and impetus for the FDA to act,” he said.
The FDA isn’t required to follow the advice of its specialists, though it usually does. A final decision on Avandia’s future will not come from the FDA for several months.
GlaxoSmithKline’s oral diabetes drug Avandia, best-known to consumers from the TV and print ads featuring pitchwoman Della Reese, is one of the most popular diabetes drugs sold worldwide, used by about a million people in the U.S.
The British drug giant presented data to the panel that showed there is no overall evidence that Avandia is different from other oral diabetic medications.
“We welcome the decision as positive for patients. The committee recognized the debilitating nature of this disease and the importance of multiple treatment options,” said Dr. Ronald Krall, chief medical officer at GlaxoSmithKline.
The outside specialists did not follow the advice of FDA officials who testified that Avandia should no longer be prescribed. Dr. David Graham, an FDA researcher at a meeting of agency advisers in Gaithersburg yesterday, said there is no evidence that Avandia provides significant health benefits. Because Avandia is not more effective than its competitors and poses a health risk of increased heart attacks, it should be pulled from the U.S. market, he argued.
At yesterday’s meeting, a split among FDA officials over whether Avandia should stay on the market emerged as Dr. Gerald Dal Pan, head of the FDA’s Office of Surveillance and Epidemiology, agreed with Dr. Graham’s position, but Dr. Robert Meyer, a top drug-safety official at the FDA, said there is fundamental disagreement within the agency about the drug.
Some physicians say fears about Avandia are unsubstantiated and contend that its removal from the market may deprive diabetes patients of effective medication.
Avandia came under fire after a study published in the New England Journal of Medicine said it increased the risk of heart attacks. That study was followed by an FDA report released last week that found the drug also increases the risk of heart attacks when taken in combination with insulin, which many diabetics routinely take to control their blood sugar.
In the federal report, FDA scientists recommend that a black-box warning, the highest caution, be added to Avandia package information to alert physicians and patients.
Health problems linked to prescription drugs, namely Avandia and Merck Co.’s Vioxx, led Congress to pass legislation this year granting the FDA stronger authority and more money to monitor the safety of drugs already on the market.
The controversy surrounding Avandia started in May, causing sales to plummet 31 percent, or $226 million in the U.S., according to GlaxoSmithKline. Avandia generated $3 billion in sales worldwide last year. Federal investigators have not found similar problems with Avandia’s primary competitor, Actos, made by Takeda Pharmaceuticals, which increased sales in the wake of Avandia’s problems.
“There’s been a lot of damage done already,” said Linda Bannister, a pharmaceutical analyst with the investment firm Edward Jones. “Even if things go their way, [GlaxoSmithKline] has a lot of work to get the drug back on its feet.”
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