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Atrial fibrillation trial halted; Multaq linked to other heart problems

July 07, 2011|By Marissa Cevallos, HealthKey / For the Booster Shots blog
  • Sanofi announced Thursday it is halting a drug trial of Multaq in patients with permanent atrial fibrillation because of heart-related side effects. The drug is still approved for patients with the less serious, non-permanent, atrial fibrillation.
Sanofi announced Thursday it is halting a drug trial of Multaq in patients… (P. Salutos / Custom Medical…)

A trial of the drug Multaq, used to treat abnormal heart rhythm, has been halted over concerns of other heart-related side effects, drug maker Sanofi announced Thursday.

Multaq, also known as dronedarone, is approved for patients with the non-permanent kind of atrial fibrillation, the less serious form of the heart condition in which irregular rhythms prevent blood from flowing normally in the body. The trial, known as the PALLAS study, was testing Multaq’s usefulness in patients with permanent atrial fibrillation (more than 6 months of the abnormal rhythms).

The company didn’t elaborate much on the “significant increase in cardiovascular events” that prompted it to ask patients in the study to stop taking the drug. But it had this to say in its news release:

“The benefit-risk of Multaq remains unchanged in its approved indication in non-permanent [atrial fibrillation]. Patients currently taking Multaq should not stop their therapy and should consult their treating physician should they have any questions.”

Cardiologist and blogger Dr. Westby Fisher from NorthShore University HealthSystem in Evanston, Ill., had this to say on his blog Dr. Wes:

“I suspect many doctors will now think long and hard before leaping to dronedarone as their ‘first line’ therapy despite the current recommendations of our ‘guidelines.’ More likely, this drug will be used when there are no other options (and there are those cases).”

This isn’t the first time the drug’s unintended effects have been in the headlines. In January, the FDA alerted consumers that some patients taking Multaq developed severe liver problems after only a few months on the drug, including two cases of acute liver failure that required a transplant. Sanofi said in Thursday’s news release that liver side effects didn’t play into the decision to halt the trial.

And last year, cardiologists from the Cedars-Sinai Medical Center said that generic alternatives work better than Multaq and that the drug should be considered only when other alternatives don’t work.

The Mayo Clinic outlines the treatments for permanent atrial fibrillation, including resetting the heart’s rhythm via electrical shock and a handful of drugs, including Multaq, to ward off future episodes.

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