Multaq Faces FDA Scrutiny As Safety Concerns Mount

The U.S. Food & Drug Administration (FDA) said yesterday that it is continuing to review the safety of <"">Multaq, as more and more specialists report they are no longer prescribing the drug. Multaq has been linked to a number of serious side effects, including liver failure and worsening heart problems.

As we’ve reported previously, Multaq was approved to treat temporary atrial fibrillation. It was touted as a safer alternative to amiodarone, a generic medicine associated with serious liver and lung risks. Approximately 400,000 patients worldwide have been treated with Multaq since it came on the market in 2009.

According to a report in The Wall Street Journal, Multaq was associated with a higher death rate even before it was approved in 2009. It already carries a boxed warning saying that the drug more than doubled the risk of death for the sickest heart-failure patients in one study. Before it was cleared by the FDA, reviewers “questioned the results of a second trial suggesting that the drug could ward off hospitalization, saying the standards for hospitalization can vary.” The reviewers also concluded Multaq “presents a problem that the label alone may not be able to cover,” the Journal said. Still, an FDA advisory panel backed the drug, finding it could help some patients. However, according to a transcript of the advisory panel meeting reviewed by the Journal, the members worried whether it was possible to distinguish patients who died from others who might benefit from Multaq.

Since then, concerns about the safety of Multaq have only grown. In January, the FDA announced that the U.S. label for Multaq had been updated, following reports of liver damage, including severe liver failure, associated with the drug. Then in July, the FDA announced that it was reviewing information from a clinical trial that was halted after moderately sick patients with permanent atrial fibrillation treated with Multaq experienced double the rate of death and stroke.

There are also questions about Multaq’s effectiveness. Last year, for example, cardiologists from the Cedars-Sinai Medical Center said last year that generic alternatives work better than Multaq and that the drug should be considered only when other alternatives don’t work.

Now, according to The Wall Street Journal, some doctors said that, because of published studies and their own clinical experience with the drug, they no longer recommend Multaq. These doctors include Sanjay Kaul, a cardiologist at Cedars-Sinai Medical Center in Los Angeles who was one of the FDA advisory panel that recommended the agency approve Multaq in 2009. “It seems like it’s not even safe in intermediate-risk patients,” Kaul told the Journal.

A cardiologist from Louisville, Kentucky, told the Journal that many doctors have similar concerns about Multaq. “I’m surprised that the drug has persisted,” John Mandrola ” I don’t know any of my colleagues who would start a patient out on Multaq. It just doesn’t work.”

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