FDA Advisory Panel Takes Up Avandia Tomorrow

A panel of medical experts is scheduled to meet tomorrow to discuss if the U.S. Food and Drug Administration (FDA) should or should not pull the controversial diabetes medication, <"http://www.yourlawyer.com/topics/overview/avandia">Avandia, from the U.S. market, writes The Wall Street Journal. The panel will be comprised of experts external to the FDA.

Recently, we wrote that, based on a 756-page briefing posted on its Website, Avandia has continued to raise safety concerns with staff there. Recent FDA analyses criticized the drug, noted the Journal.

Avandia, known generically as rosiglitazone, has been the subject of safety concerns for several years. In November 2007, a black box warning—the FDA’s strongest safety warning—detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling. The black box was added after the Cleveland Clinic published a meta-analysis of 42 clinical trials that revealed that patients taking Avandia experienced a 43-percent increased risk of having a heart attack.

Now, the drug is at the center of a dispute that could change how the agency responds to drug safety, specifically concerning medications and devices that have been approved and are on the market, noted the Journal.

Type 2 diabetes affects some 23 million Americans, said the Journal and the panel meeting is considered significant. “This is a defining moment” for [FDA Commissioner] Peggy Hamburg and [Deputy Commissioner] Josh Sharfstein, said former FDA Commissioner David Kessler in an interview, quoted the Journal. “Who at the FDA will decide what happens to Avandia?” Kessler asked, noting that whoever makes the decision will also be the group managing how the FDA handles drug safety, approvals, and withdrawals going forward, wrote the Journal. When asked about who would decide Avandia’s fate, Dr. Sharfstein said, “The FDA is going to make a decision on behalf of the public,” reported the Journal.

The FDA advisory panel will also look at a study conducted by Dr. David Graham of the FDA’s Center for Drug Evaluation and Research that found that patients in the U.S. Medicare system who took Avandia may have suffered as many as 48,000 heart attacks, strokes, and other problems between 1999 and 2009. Graham’s study involved 227,500 patients, making it the largest to date, and found that patients who took Avandia were 27 percent likelier to suffer a stroke, 25 percent likelier to develop heart failure, and 14 percent likelier to die versus those who took another drug called Actos.

According to a prior Journal article, the FDA advisory panel will be asked to vote on several actions the FDA could take regarding Avandia, including allowing Avandia to stay on the market or adding restrictions on its use, such as only allowing certain doctors to prescribe the medication. The meeting will take place over two days; the vote will occur Wednesday. The FDA is not required to follow the advise of such panels, but usually does so.

Actos, made by Takeda, has been found in some studies to be equally effective in lowering glucose levels as Avandia without the same cardiac risk, said the Journal. Meanwhile, according to some experts, proving Avandia causes cardiovascular problems could be challenging given that diabetes can lead to such issues, noted the Journal.

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