FDA Issues Alerts on the Heart Drug Multaq

FDA Issues Alerts on the Heart Drug Multaq

July 22nd, 2011 // 12:53 pm @ jmpickett

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.

Best Selling Webinar 2010 – Sept. 29, 2 PM – How to Write FDA-Compliant Quality Agreements
Speaker: Alan Minsk

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.

The agency said “a critical question” remained: whether the halted study would also foretell problems with those patients who took Multaq for the approved uses. Those patients should talk to their physicians, the F.D.A. said.

The European Medicines Agency said that it would provide further guidance in September.

Sanofi, in a statement, said “the benefit-risk profile remains positive” for the approved use.

Dr. Robert A. Harrington, a Duke University professor, said that the study was “concerning” but that he would await final data. He was chairman of the panel that voted for approval.

Dr. Sidney M. Wolfe, a member of the panel who opposed Multaq, said, “The drug is really too dangerous.”

Regulators and Sanofi-Aventis emphasized that physicians should never prescribe Multaq to patients with longer-term fibrillation.

Multaq is one of Sanofi’s most important new drugs, with sales of $246 million last year.