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Multaq Subject To New Restrictions

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Heart drug, Multaq, is subject to new restrictions, according to federal health officials. New safety warnings are being mandated following a study by drug maker, Sanofi, that linked Multaq (dronedarone) to serious cardiac events as well as a review of clinical trial data by the U.S. Food & Drug Administration (FDA) that revealed a link between Multaq and increased heart attack, stroke, and death in some patients.

Multaq is approved to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted.

The new boxed warning stresses study results that revealed that Multaq doubled risks for cardiac complications in patients with permanent AF, said The Associated Press (AP). Permanent AF is a condition in which the heart’s chambers pump out of rhythm. The new label also emphasizes that Multaq is only approved for short-term AF and AFL, a related condition, said the AP.

The FDA announced that it completed a safety review of Multaq that revealed an increased risk of serious cardiovascular events, including death, when used by patients in permanent AF; the FDA’s review was based on data from the PALLAS and ATHENA clinical trials. The revised Sanofi label, which was written collaboratively by the FDA and Sanofi and has been revised with the following changes and recommendations:

• Healthcare professionals should not prescribe Multaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients.
• Healthcare professionals should monitor heart (cardiac) rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in AF, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted.
• Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF (known as paroxysmal or persistent AF).
• Patients prescribed Multaq should receive appropriate antithrombotic therapy.

The FDA initiated its Multaq safety review in January, updating the drug’s label to include “liver injury, including acute liver failure requiring transplant, has been reported in patients treated with Multaq.” In July, the FDA expanding this warning to include heart side effects, following PALLAS study results that revealed that patients taking Multaq for permanent AF were at a two-fold risk of death and increased risks for heart attack and stroke.. PALLAS was ceased over the summer after Multaq patients experienced higher-than-anticipated adverse cardiac events.

Yesterday’s FDA Drug Safety Communication indicated that 25 Multaq patients died during PALLAS, as opposed to 13 in the placebo group. Of those, 14 Multaq patients experienced sudden death or death from arrhythmia, versus 4 in the placebo group. In the Multaq group, 23 patients suffered stroke and 43 were hospitalized with heart failure, versus 10 and 24, respectively, from the placebo group. The FDA also reviewed ATHENA data, which was used to grant Multaq’s approval for temporary AF. The Safety Communication indicated that Multaq patients did not suffer increased cardiovascular death, stroke, or heart failure risks and, because of this, the FDA maintains that Multaq provides a benefit for patients with non-permanent AF.

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