BY ANDREW BRIDGES THE ASSOCIATED PRESS
WASHINGTON — The widely used diabetes drug Avandia should remain on the market, government health advisers recommended Monday, saying evidence of an increased risk of heart attack doesn’t merit removal.
The nonbinding recommendation to the Food and Drug Administration came on a majority vote by the panel. The tally wasn’t immediately available.
“We’re being asked today to take a very draconian action based on studies that have very significant weaknesses and are inadequate for us to make that kind of decision,” said Rebecca Killion, a Bowie, Md., diabetic and the panel’s patient representative.
However, in an earlier 20-3 vote, the panelists said that available data show the drug does increase heart risks. Panelists said the drug’s warning label should be updated and there should be additional study.
Earlier, FDA scientist Dr. David Graham told the joint panel of experts that the drug’s heart risks, combined with its lack of unique shortterm benefits in helping diabetics control blood sugar, meant continued sales were not justified.
Brownsville pharmacies have seen a decrease in Avandia prescriptions since the FDA’s security alert was announced March 12.
“I haven’t seen it prescribed a lot anymore,” said pharmacist Diana Sanchez from Central Medical Pharmacy on Central Boulevard.
“I noticed the change about two weeks after (the FDA alert), when people were coming in for refills,” she added.
A teacher at the Center for Diabetes Management at Valley Baptist Medical Center, Leo Vasquez said the decrease is prompted by private doctors and not specialists.
“Physicians took a lot of questions after the uproar and some may have been persuaded to stop prescribing it,” Vasquez explained.
“If Avandia is taken off the market, it won’t be because of product defect. It will be because of (low) product sales,” he said.
Local family physician David Champion said he hardly prescribes the medication, but a few of his patients did express concern when they saw the alert.
“If they told me they wanted to be taken off of it, I prescribed something else,” he said. “Liability wise, if something happens, whether it was due to the drug or not, the patient may come back and blame it on that prescription.”
Brownsville Herald reporter Christian
Martell contributed to this story.
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