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Page: << Prev | 1 | 2 | 3 | Next >> That data could help decide whether or not Avandia remains on drug store shelves, experts said.
"A critical question to be resolved in determining appropriate regulatory action is whether the anticipated therapeutic benefit of rosiglitazone outweighs the demonstrated cardiovascular risk," one FDA reviewer concluded according to the Times report.
In the Diabetes Care study, Singh's team collected data on more than 78,000 patients taking either of the drugs. These patients were included in previously published studies and in case reports.
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Not only did the drugs double the risk of heart failure, but the increased risk was seen with both high and low doses, the team found.
Heart failure developed in some patients taking lower doses than are commonly prescribed. The average time for heart failure to develop was 24 weeks after starting the drugs, the researchers found.
Heart failure wasn't confined to older patients. Twenty-five percent of the patients who developed heart failure were under 60. In addition, both men and women developed heart failure while taking the drugs, Singh noted.
Singh's group suspect that Avandia and Actos may boost heart failure risk by encouraging fluid retention.
Current guidelines allow the use of these drugs in patients with early-stage heart failure. "Based on our information, that may have to change," Singh said.
Singh noted that there are alternative drugs available. "Doctors should be aware of the risk," he said. "Patients who are on these drugs and start developing symptoms of heart failure should see their doctor immediately, and patients not on these drugs should look at alternatives."
One expert believes that patients taking Avandia and Actos face not only an increased risk of heart failure, but Avandia users also face a 43 percent increased risk of heart attack.
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