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April 21, 2011

Here is an important new warning about the heart drug Multaq (generic name: dronedarone), which is linked to severe liver injury.

We have just classified this medication as a DO NOT USE medication.

Do not discontinue use of any medication without talking to your doctor first.

On January 14, 2011, the Food and Drug Administration (FDA) issued a safety announcement to health professionals and consumers about cases of rare, but severe liver injury in patients taking the anti-arrhythmic drug Multaq. The agency cited the cases of two patients who experienced liver failure and required liver transplants.

Then, on March 10, 2011, the maker of Multaq, Sanofi-aventis and Health Canada sent Canadian health professionals and patients much more comprehensive letters reporting that, in the 16 months from the launch of Multaq in July 2009 through November 2010, Sanofi-aventis had received 155 cases of liver injury (87 of these serious) including hepatic failure.

Read the full letter for patients and letter for doctors.

What You Should Do

Sanofi-aventis provided the following guidance for consumers:

Patients need to discuss this new safety information with their healthcare professionals.

Patients should immediately report to their doctors any symptoms that suggest possible liver injury, such as "loss of appetite, nausea, vomiting, unusual tiredness, right upper stomach area pain or discomfort, yellowing of the skin or the whites of the eyes (jaundice), unusual darkening of the urine, or itching."

Patients should discuss with their healthcare professionals the need for periodic liver function tests.

We have had previous concerns about other safety problems with Multaq. We opposed its initial approval. We are now classifying Multaq as a DO NOT USE drug. You should discuss with your health care providers what alternative medication or procedure would be best for you.

Do not discontinue use of any medication without talking to your doctor first.

Although the drug is not recommended for patients with severe heart failure, a black box warning on the label of the drug states that:

"In a placebo-controlled study in patients with severe heart failure requiring recent hospitalization or referral to a specialized heart failure clinic for worsening symptoms, patients given dronedarone [Multaq] had a greater than two-fold increase in mortality. Such patients should not be given dronedarone."

Report any adverse effects to the FDA Medwatch program.