Posts Tagged 'Avandia withdrawn'

Diabetes drug Avandia to be pulled from retail shelves

The diabetes drug Avandia will be pulled from retail pharmacy shelves in November because it poses such a big heart attack risk, the federal government announced Tuesday. When the new program goes into effect on Nov. 18, only certified doctors will be allowed to prescribe the drug, and only to patients who’ve been informed of the risks and who will fill their prescriptions by mail order through specific pharmacies.

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Avandia Stays on the Market, But For How Long?

After two days of contentious discussion, a federal advisory committee voted on Wednesday to keep the troubled diabetes drug Avandia (rosiglitazone) on the market, but with added restrictions for its use. Experts had expected the 33-member panel to recommend removing the drug altogether, based on evidence that Avandia, prescribed to control blood sugar in patients with Type 2 diabetes, increases risk of heart attack. That is a particularly worrisome side effect in this population, considering that diabetes itself raises the risk of heart disease.

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FDA Mulling End to Avandia-Actos Trial on Safety Worries

The FDA is considering cutting short a trial comparing the safety of two diabetes drugs — GlaxoSmithKline’s Avandia and Takeda’s Actos, the WSJ reports. Given that Avandia has been linked since 2007 to an increased risk of heart attacks, some scientists have said it’s not ethical to put study participants at risk. If the trial is stopped, the FDA will also consider asking Glaxo to stop selling the drug.

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Research Ties Diabetes Drug to Heart Woes

Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market. The reports say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009. “Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.

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