FDA to Review Multaq After Sanofi Halts Clinical Trial

The FDA has decided to review the atrial fibrillation medication Multaq after the makers of the medication stopped a clinical trial when some of the patients developed cardiovascular problems.

The FDA’s intention in the review is to find out how the drug will affect patients that are currently taking the medication as a treatment for its approved purposes. And the FDA is not the only agency interested in reviewing the drug — the European Medicines Agency also announced that it will be reviewing Multaq. Both agencies are hoping to find out just how safe Multaq is now that the clinical trial (centered on patients that have permanent atrial fibrillation problems) has been stopped. The cardiovascular problems that some of the patients suffered have the agencies concerned for patient safety when taking Multaq.

Right now, Multaq is currently approved to treat patients that have non-permanent atrial fibrillation. The condition causes patients to suffer from an irregular heartbeat. Multaq has been sold in Europe since July 2009 and it started being sold in the U.S. early last year. The drug has already been linked to liver failure in some patients and the most recent clinical trial has shown that the drug can also cause cardiovascular problems.

A warning has been placed on the FDA’s website about Multaq which reads “At this time, patients taking Multaq should talk to their healthcare professional about whether they should continue to take Multaq for non-permanent atrial fibrillation. Patients should not stop taking Multaq without talking to a healthcare professional. Healthcare professionals should not prescribe Multaq to patients with permanent atrial fibrillation.”

The website also lists the study that was sponsored by Sanofi Aventis that started all of this: The Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS)

If you or a loved one has suffered from liver or cardiovascular problems after taking Multaq, contact attorney Greg Jones today for a free consultation. I am experienced at fighting drug-related lawsuits and may be able to help you recover money for your injuries.

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