Au Revoir, Avandia? FDA Reviewers Urge Agency to Pull Drug

"I haven't prescribed Avandia for some time now, and I am not surprised that the recommendation is to pull it off from the market," said Dr. Albert Levy, assistant professor of medicine at the Mount Sinai School of Medicine in New York. "Any medicine with such a bad reputation is a potential life-threatening risk for the patient and a possible malpractice risk for the doctor."

Doctors, Diabetes Experts Split over Pulling Avandia

"I cut back on Avandia use when it was first linked to heart failure. This makes my willingness to use it even less," said Dr. Randy Wexler, assistant professor of Clinical Family Medicine at Ohio State University Medical Center in Columbus. "As a wise old doctor once told me, 'Don't be the first to use a new drug, and don't be the last.'"

"I doubt anyone is using this anyway," said Dr. Thomas Schwenk, chair of the department of Family Medicine at the University of Michigan Medical School. "[I] suspect many physicians -- including me -- thought it was already gone."

A few doctors, however, said the drug should remain as an option.

"I think it is safe enough to stay on the market, as long as the warnings are clear, which they are," said Dr. John Sutherland, program director emeritus of the Northeast Iowa Medical Education Foundation and Family Medicine Residency in Waterloo, Iowa.

And some diabetes experts noted that it has yet to be conclusively proven how, exactly, Avandia might bring about heart disease.

"We have known for some time that Avandia as well as Actos ... cause fluid retention, and that this can cause congestive heart failure in susceptible patients, when neither drug should be used," said Dr. Christopher Saudek, professor of Endocrinology and Metabolism at Johns Hopkins University School of Medicine in Baltimore. "The real question is whether Avandia causes more heart attacks, and the data there, in my mind, are inconclusive at best."

A Regulatory Failure?

The case itself could have implications beyond the doctor's office. Following the 2007 analysis, the FDA added a boxed warning to Avandia to address the heart risks. It also asked GSK to perform a cardiovascular safety trial to compare Avandia to other diabetes treatments such as Actos -- a trial that is still ongoing.

Around the same time, Baucus and Grassley began investigating how the FDA has handled rosiglitazone and whether GSK knew about the risk of heart attacks and heart failure that its drug posed.

Since 2007, the lawmakers have reviewed hundreds of thousands of pages of internal GSK documents and have spoken with GSK employees and anonymous whistle blowers, they said in a press release announcing the findings of their two-year investigation.

According to a letter Baucus and Grassley sent to FDA Commissioner Dr. Margaret Hamburg, their review uncovered a "alarming" analysis from a 2008 analysis conducted by two FDA safety reviewers who examined all available studies comparing rosiglitazone to pioglitazone.

Senators Take Aim at Drug Trial, Federal Regulators

Baucus and Grassley wrote in the letter that the reviewers concluded, "There is no evidence that rosiglitazone confers any unique health benefits over pioglitazone while there is strong evidence that rosiglitazone confers an increased risk of [heart attacks] and heart failure compared to pioglitazone."

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