A clinical trial for <"http://www.yourlawyer.com/topics/overview/multaq-dronedarone-liver-damage-failure-lawsuit-lawyer-attorney">Multaq (dronedarone) has ended early after a significant number of heart-related side effects were seen in the study. The trial, known as the PALLAS study, was testing Multaqâ€™s as a treatment for permanent atrial fibrillation.
The drug is already approved to treat temporary atrial fibrillation, or abnormal heart rhythm. Multaq was designed to be a safer alternative to amiodarone, a generic medicine with serious liver and lung risks that is only approved for life-threatening irregular beating in the heartâ€™s lower chambers. Approximately 400,000 patients worldwide have been treated with Multaq since it came on the market in 2009.
According to a statement issued by Sanofi yesterday, the PALLAS study was stopped after an independent safety monitor saw a “significant increase in cardiovascular events” in the group of patients taking Multaq. The company said it was notifying regulatory authorities in all countries were Multaq was approved.
According to the Sanofi statement, 70% of the 3,149 patients enrolled had permanent atrial fibrillation for over two years. This contrasts with the ATHENA study (used to approved Multaq), in which no patients enrolled had permanent atrial fibrillation. Patients in the PALLAS study were older than that inn the ATHENA trial.
This is the second time this year Multaq has made news because of safety concerns. 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. According to an FDA alert issued at the time, two cases of severe liver failure requiring transplantation had been reported among Multaq patients. The FDA suggested that health care providers consider having patients undergo periodic liver enzyme tests, especially in the first six months of treatment with Multaq.
The liver injury concerns also prompted regulators in Europe to launch safety reviews of Multaq. Late last month, France’s top medical regulator deemed Multaq “inadequate.” According to a report from FiercePharma, that could result in the drug being removed from the state reimbursement formulary.
In its statement announcing the halt of the PALLAS study, Sanofi said liver side effects didnâ€™t play into the decision to end the trial early.
There have also been questions about the drug’s effectiveness. According to the Los Angeles Times, 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 donâ€™t work.