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New FDA Warning for Multaq

July 22nd, 2011

Multaq (generic name: dronedarone) is a drug used to treat patients who have a common type of abnormal heart rhythm called atrial fibrillation, or atrial flutter.

In January, the U.S. Food and Drug Administration (FDA) warned that some people taking Multaq developed severe liver injury, including two cases of acute liver failure that lead to liver transplant. That was pretty bad, but today’s information is worse.

On July 21, 2011, the FDA notified healthcare professionals that a clinical trial evaluating Multaq was stopped when an early evaluation of the data found a that patients taking the drug had a  two-fold increase in death, as well as two-fold increases in stroke and hospitalization for heart failure.

According to the manufacturer’s website: MULTAQ is a prescription medicine used to lower the chance you would need to go into the hospital for heart problems. Sadly, the drug seems to cause more problems than it solves. Liver failure…stroke…heart failure…death. This is not a mild warning, it is a call to action.

The FDA has this advice:

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.

In addition, patients taking Multaq should watch for signs of liver problems and contact their physician immediately if they experience anorexia (lack of appetite or desire to eat), nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching.

The FDA, Health Canada, and the European Union will all be conducting reviews of the drug and the latest data from the clinical trial. No doubt, this will not be the last we hear about the problems of Multaq.

If you believe that you have suffered injury or severe side effects from taking Multaq and would like to explore your legal options, the lawyers of HensonFuerst are available 24 hours a day, 7 days a week. You can reach us by phone (1-800-4-LAWMED) or by the contact form on our website (www.lawmed.com).

If you have questions, HensonFuerst has answers.