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

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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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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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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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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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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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 out Wednesday.

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GlaxoSmithKline, the manufacturer of Avandia, has already admitted that Avandia does contribute to bone fractures in women. However, the latest research goes further in understanding the issue, just what is happening to those brittle bones, and what it is that’s making them brittle in the first place.

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Avandia, a drug used in the treatment of type 2 diabetes, has been at the center of controversy since being linked to an increased risk of heart attack last May. An update to the black box warning-today’s strongest drug warning-is now being added to the Avandia label.

The U.S. Food and Drug Administration (FDA) advised that GlaxoSmithKline, Avandia’s maker, agreed to add the new warning to the existing black box warning. But, despite the revision, the FDA will not withdraw Avandia from the market, claiming that evidence for increased heart attack is inconclusive and does not appear to be higher in Avandia than other type 2 diabetes treatments. In the meantime, the FDA asked GlaxoSmithKline to conduct a long-term study comparing Avandia with other type 2 diabetes drugs. The trial will likely commence in a year; however, full results will not be available until 2014. Patient advocates and FDA critics consider the black box warning a weak response to Avandia’s safety issues and have requested Avandia be pulled from the market.

Avandia breaks down the body’s resistance to insulin but has long been known to cause fluid retention, a major risk factor for congestive heart failure. Evidence does not indicate Avandia and other oral anti-diabetes drugs-thiazolidinediones-prevent cardiovascular risk as a result of reducing blood sugar.

The American Diabetes Association and the European Association for the Study of Diabetes released a revised consensus statement stating that emerging information suggests additional hazards associated with thiazolidedione and rosiglitazone (Avandia) and may result in increased risk of myocardial infarctions. In October, the US Department of Veterans Affairs (VA) announced it was dropping Avandia from its prescription drug formulary stating their review concluded that, in some, Avandia did not afford the same margin of safety as other diabetes medications. The VA accounted for nearly 10-percent of Avandia’s US sales.

In November, Health Canada sent a letter to Canadian health professionals advising Avandia could no longer be prescribed as monotherapy for type 2 diabetes or in combination with sulfonylurea. In May, research based on 42 Avandia studies confirmed a 43-percent increased risk of heart attack among patients taking the drug. In August, Avandia’s warning label was changed to warn that Avandia and others in its class might worsen heart failure.

A Congressional Committee Report found that company executives made a concerted effort to intimidate a diabetes expert into keeping quiet about Avandia’s safety problems, alleging that Glaxo Chief Executive Jean-Pierre Garnier and former research chief Tachi Yamada were involved. An internal government memo dated July 16, 2002 analyzed 47 early FDA reports of patients who went into heart failure and required hospitalization while taking Avandia. The report contained warnings from Federal investigators that Avandia might cause heart failure.

Over six million Americans have used the drug to treat adult-onset, or type 2, diabetes and the concern about Avandia is nothing new. The association between Avandia and increased heart failure risk has been known since 1999 when the drug was first approved.

Avandia was Glaxo’s second most popular drug in 2006, with sales of $3.3 billion. Sales have plummeted since publication of evidence linking Avandia with increased risk of heart attack and failure.

November 29th, 2007 by Staff with NewsInferno.com

Risks associated with Avandia have led the American Diabetes Association to call on doctors to use more caution when prescribing oral medications to treat people with type two diabetes.

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