Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The 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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New 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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GlaxoSmithKline (GSK) has agreed to pay more than $250 million to resolve about 5,500 claims that its type 2 diabetes drug Avandia (rosiglitazone) caused heart attacks and strokes in patients who used the drug. The payout will help GSK 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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