Avandia Severely Restricted by FDA

Citing heart risks from <"http://www.yourlawyer.com/topics/overview/avandia">Avandia, the US Food & Drug Administration (FDA) has decided to place severe restrictions on the controversial diabetes drug. According to The New York Times, patients in the US will only have access to Avandia if they and their doctors attest that they have tried every other diabetes medicine and that patients have been made aware of Avandia’s cardiac side effects.

At the same time, European regulators went even further, suspending sales of Avandia all together.

Over the summer, an FDA advisory panel voted 20-12 to recommend that Avandia be allowed to stay on the market. However, 10 panel members voted that its sales should be restricted and that warnings on its label regarding heart risks be strengthened.

Avandia, manufactured by GlaxoSmithKline, is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus. Its active ingredient is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl. The newly-imposed restrictions will also apply to those drugs.

Since November 2007, Avandia’s label has included a black box warning – the FDA’s strongest safety alert – detailing its association with myocardial ischemia. The black box was added after the Cleveland Clinic published a meta- analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack. Since the addition of the black box, evidence linking Avandia to an increased risk of heart attacks has continued to accumulate.

“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” FDA Commissioner Margaret A. Hamburg, M.D. said in a statement announcing the new Avandia restrictions. “We are seeking to strike the right balance to support clinical care.”

Also today, the FDA ordered Glaxo to convene an independent group of scientists to review key aspects of the company’s clinical trial known as RECORD, which studied the cardiovascular safety of Avandia compared to standard diabetes drugs. RECORD, which was released in 2009, did not find increased heart risks, as other Avandia studies have. It was touted by Glaxo as evidence of the drug’s safety.

However, documents posted on the FDA Web site in advance of this summer’s Avandia advisory panel meeting characterized RECORD as “inadequately designed and conducted to provide any reassurance about the CV (cardiovascular safety) of rosiglitazone.” The memo further stated that the RECORD results “confirm and extend the recognized concerns regarding heart failure” and possibly suggest an increased risk for heart attacks. The FDA review of RECORD found at least a dozen instances in which patients taking Avandia suffered serious heart problems that were not counted in the trial’s tally of adverse events, mistakes that further obscured Avandia’s heart risks.

Finally, the FDA has halted a Glaxo-funded clinical trial known as TIDE and rescinded all of the regulatory deadlines for completion of the trial. The TIDE trial compares Avandia to Actos and to standard diabetes drugs.

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