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July 22, 2011

F.D.A. Issues Alerts on the Heart Drug Multaq

Quoted from http://www.nytimes.com/2011/07/22/business/fda-issues-alerts-on-the-heart-drug-multaq.html

F.D.A. Issues Alerts on the Heart Drug Multaq

By DUFF WILSON

Published: July 21, 2011

American and European regulators issued safety alerts on Thursday about Multaq, a drug approved two years ago to treat abnormal heart rhythms.

The Food and Drug Administration said a study of the drug in patients with a long-term form of the disease, known as atrial fibrillation, showed twice as many deaths as those who did not take the drug.

The alerts provided the first details of a 3,000-patient trial halted by Sanofi-Aventis two weeks ago. The company had cited “a significant increase in cardiovascular events.”

Multaq was approved for short-term arrhythmia lasting less than six months. Since then, the F.D.A. said, 241,000 Americans have received prescriptions.

[Article continues at original source]

Posted at 11:18 AM in Multaq |

Tags: cardiovascular deaths, drug injury, FDA warning, heart failure, Multaq, Sanofi, side effects, strokes

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