| "Despite evidence it increases risk of heart attack, Avandia may only get an added warning label." " WASHINGTON - A pair of Food and Drug Administration advisory panels called Monday for new warnings for the widely used diabetes drug Avandia because of evidence that it significantly raises the risk of heart attack, but they stopped short of recommending that the drug be pulled from the market, as some FDA officials had urged." "The 22-1 vote to allow continued sales of the drug ends years of controversy among regulators, drug company officials, physicians and advocates for patients, who have offered dueling interpretations of contradictory safety studies. The pills are taken by more than 1 million Americans and racked up $3.4 billion in sales last year for their maker, GlaxoSmithKline of North Carolina." "Dr. Richard Bergenstal, executive director of Park Nicollet's International Diabetes Center in Minneapolis, said diabetes patients who are taking Avandia should not panic or stop, but should talk to their doctor about it." "Like many Minnesota diabetes patients, Norman Teigen, 64, of Hopkins, a Vietnam veteran who gets his health care at the Minneapolis Veterans Medical Center, read the news with great interest, but said he'll defer to his doctor. He said Avandia, which he has taken for four years, has had "quite spectacular" results in controlling his Type 2 diabetes." ""I am not thinking of arbitrarily discontinuing this prescription," he said. "If my VA doctor advises me to do that, I will follow her instructions. I trust her completely."" "For all diabetes patients, high blood sugar is the major risk, and controlling it should come first, Bergenstal said. A doctor can help a patient with risk factors for heart disease decide what drug makes the most sense." ""If you're on Avandia and it's working well, controlling your blood sugar at the moment, and you feel the benefits outweigh the risk, then you might choose to continue using it while we wait for further data," he said." "A majority of the FDA advisers sided with Glaxo, which offered hundreds of pages of evidence suggesting that Avandia poses no greater risk ... read the whole article |