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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An experimental new diabetes drug, lixisenatide, combined with Lantus, helped patients better control the level of sugar in their blood, according to results from a phase three clinical trial sponsored by Sanofi-Aventis SA. Lantus is the No. 1 best selling insulin in the world in both sales and units.

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The 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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A U.K. advisory committee has voted to remove the diabetes drug Avandia from the U.K. market over concerns that it can aggravate heart problems in some users. European regulators will begin reviewing the drug’s safety profile this week and are expected to make a decision on the fate of the medication by September 23. The drug remains on the market in the U.S. despite concerns raised at a recent Food and Drug Administration (FDA) advisory panel meeting, in which it was discussed whether to remove the drug from the American market because of increased cardiovascular risks. The board ultimately voted to keep the drug in some form.

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After two days of deliberation, a Food and Drug Administration (FDA) advisory panel voted Wednesday to keep the diabetes drug Avandia on the market despite studies that suggest the medication puts people at greater risk of heart attacks and strokes. The decision was hardly decisive. Among five possible recommendations, the option to withdraw Avandia from the market received the most votes, however a majority voted to keep it on the market in some form. Thus the drug will still be available.

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While an expert panel in the U.S. reviews evidence to decide whether to pull the popular diabetes drug Avandia off the market due to an increased risk of cardiovascular events, BusinessWeek reports that the drug’s maker, GlaxoSmithKline (GSK), has agreed to pay about $460 million to settle lawsuits alleging the company hid evidence that Avandia increased the risk of heart attacks and strokes. GSK faces more than 13,000 lawsuits and has agreed to settle about 10,000 of them. Avandia was to face its first trial in federal court in October. BusinessWeek reports that the FDA review helped prompt the company’s decision to settle the suits.

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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, GlaxoSmithKline (GSK), influenced the results of a study asserting the safety of Avandia.

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It’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 GlaxoSmithKline (GSK) 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 heart attacks a month. That request by the oversight board was based on the findings from the RECORD study.

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