In the month after a surprising analysis revealed possible heart risks from the blockbuster diabetes drug Avandia, reports of side effects to federal regulators tripled.
The sudden spike is a sign that doctors probably were unaware of the drug's possible role in their patients' heart problems and therefore may not have reported many such cases in the past, several experts said.
Moncef Slaoui,, chairman of Research and Development at GalaxoSmithKline testifies on Capitol Hill in Washington, in this Wednesday, June 6, 2007 file photo, before the House Oversight and Government Reform committee hearing on the diabetes drug Avandia. In the month after a surprising analysis revealed possible heart risks from the blockbuster diabetes drug Avandia, reports of side effects to federal regulators tripled. (AP Photo/Susan Walsh) (Susan Walsh - AP)
It also shows the flaws of the safety tracking system and suggests that a better one might have detected a potential problem before the drug had been on the market for eight years.
Avandia is used to control blood sugar, helping more than 6 million people worldwide manage Type 2 diabetes, the kind that is linked to obesity. These people already are at higher risk for heart attacks, so news that the drug might raise this risk by 43 percent was especially disturbing.
In the 35 days after May 21, when the New England Journal of Medicine published the analysis on the Internet, reports of heart attacks, deaths and hospitalizations leaped. The sharp rise in reports of heart problems appears in data obtained by The Associated Press through a Freedom of Information Act request to the federal Food and Drug Administration. ...more
Thursday, August 2
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