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

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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Two U.S. senators are asking the Food and Drug Administration (FDA) why the diabetes drug Avandia is still on the market after an agency oversight board in 2008 urged the agency to remove the GlaxoSmithKline (GSK) drug from the market because it was causing 500 additional heart attacks a month. Senators Max Baucus and Charles Crassley said the major drug company even knew about the dangers of Avandia but initiated a cover up to keep the drug available to consumers.

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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 GlaxoSmithKline’s one-time blockbuster drug a sales boost.

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Consumer watchdog group Public Citizen released a petition on Thursday calling for an immediate ban on GlaxoSmithKline’s diabetes drug Avandia. In a petition addressed to Commissioner Dr. Von Eschenbach of the U.S. Food and Drug Administration, Public Citizen urged the ban based on trial data revealing the drug’s “multiple, serious risks.”

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A UK newspaper reported yesterday that drug giant GlaxoSmithKline (GSK) – the second largest pharmaceutical company in the world – will cut 150 or more scientists and support staff positions.

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Researchers believe that the diabetes drug Avandia may cause bone loss and long-term use may speed up osteoporosis. The thinning of the bones is dangerous and could lead to fatal fractures. The study published in the December 2nd issue of Nature Medicine suggests that usage of rosiglitazone in the treatment of type II diabetes may cause osteoporosis.

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GlaxoSmithKline’s Avandia is once again making the headlines after it was revealed that the peer reviewer looking at the now-notorious meta-analysis on the diabetes drug’s safety profile leaked a confidential copy of the article to the firm before it was published in the New England Journal of Medicine

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Older patients who took Avandia had a higher risk of heart attacks, congestive heart failure and death than those on other diabetes pills, according to a study of nearly 160,000 Canadians.

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Montgomery, AL: Joyce A. says she did not know that Avandia could cause so many health problems, at least she did not know until her doctor took her off Avandia and put her on another drug. Unfortunately, this happened after she was hospitalized two times with severe chest pains. Although she has started to recover since being taken off Avandia, she says she still experiences some pain.

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Mark D. is fighting for justice on behalf of his brother, Grant, whose health has gone downhill since he was prescribed Avandia.

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