News Tagged ‘rosiglitazone’

FDA to remove Avandia from retail pharmacies

fda logo 100x100The diabetes drug Avandia will no longer be sold at retail pharmacies beginning in November because of the serious health risks it poses to patients. The Food and Drug Administration (FDA) voted to severely restrict use of Avandia and related drugs last fall after studies showed that users with type 2 diabetes who took the drug were at a 40 percent increased risk of heart attack. Beginning in November, patients will only be able to get the drug by mail order from certified pharmacies participating in a special agency-supported program.

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FDA approves new warnings on Avandia packaging

images2 100x100New warnings for the type 2 diabetes drug rosiglitazone, better known by the brand name Avandia, has been approved by the Food and Drug Administration (FDA). The warnings, including a black box warning, will be immediately added to the safety labeling and packaging for Avandia (rosiglitazone maleate), as well as other drugs with the same active ingredient, including Avandament (rosiglitazone maleate/metformin hydrochloride), and Avandaryl (rosiglitazone maleate/glimepride).

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GSK pays out more money to settle lawsuits against deadly diabetes drug

() has agreed to pay more than $250 million to resolve about 5,500 claims that its type 2 diabetes drug Avandia (rosiglitazone) caused and strokes in patients who used the drug. The payout will help avoid the first trial over claims the pharmaceutical giant allowed the drug to be marketed despite reports that the drug was potentially deadly.

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FDA puts tight restrictions on Avandia due to heart attack, stroke risk

images2 100x100The Food and Drug Administration (FDA) voted today not to remove the Type 2 diabetes drug Avandia from the market, despite studies that indicate the medication puts users at an elevated risk for cardiovascular events, such as heart attack and stroke. But the agency did put tight restrictions on prescriptions of the drug. Meanwhile, European drug regulators announced today they will suspend the drug’s sales throughout Europe.

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FDA panel to decide fate of diabetes drug Avandia

The fate of the diabetes drug Avandia will likely be decided soon by an expert panel that has spent the past two days reviewing evidence that linked the drug to serious cardiovascular events and whether its developer and manufacturer, (), influenced the results of a study asserting the safety of Avandia.

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FDA announces it will review studies linking Avandia to heart attacks

fda logo 100x100It’s a long time coming. This week the Food and Drug Administration (FDA) announced it is reviewing the primary data from a large, long-term clinical study, known as RECORD, on possible cardiovascular risks associated with the diabetes drug Avandia (rosiglitazone). The agency said it is also reviewing on an ongoing basis a number of other published observational studies on the cardiovascular safety of the drug. The FDA’s announcement comes on the heels of news that two U.S. senators are asking why the () drug is still on the market when an FDA oversight board in 2008 urged the agency to pull the drug because it was causing 500 additional a month. That request by the oversight board was based on the findings from the RECORD study.

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Doctors and critics doubt the accuracy of Avandia study

Results of a clinical study announced in New Orleans recently appeared to exonerate Avandia from long-held suspicions that the drug causes adverse cardiovascular events in patients undergoing treatment for diabetes 2. Many doctors and other critics, however, say that the study is flawed and remain unconvinced of the findings. Financial analysts believe the results will likely give ’s one-time blockbuster drug a sales boost.

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