WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration said Thursday it is reviewing clinical data involving the Sanofi-Aventis SA (SNY) heart-rhythm drug Multaq.
The company stopped a study of the product earlier this month that involved patients with permanent atrial fibrillation after it showed a two-fold increase risk of death as well as stroke and hospitalization for heart failure. The product is approved for a different group of patients in the U.S. than those in the stopped study.
The FDA said the 2009 approval of Multaq was based on a different clinical study that showed a decreased number of deaths compared to patient on a placebo medication.
In the U.S., Multaq is approved to help maintain normal heart rhythms in patients with a history of nonpermanent types of atrial fibrillation or atrial flutter, which are heart-rhythm disorders. The drug is approved to be used in patients whose hearts have returned to a normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heartbeat.
The FDA said a "critical question is whether and how the unfavorable results" of the study that was stopped earlier this month apply to patients with other types of atrial fibrillation for which the drug is approved. Earlier Thursday the European Medicines Agency also said it was reviewing the risks and benefits of Multaq.
FDA said patients shouldn't stop taking the drug without talking to their doctors. The agency said the study results are preliminary and that it would wait until final study results are available before taking any regulatory action.
The agency said about 241,000 U.S. patients have received Multaq prescriptions since July 2009.
Thursday, July 21, 2011
FDA Reviewing Sanofi-Aventis Heart Drug Multaq - FoxBusiness.com
via foxbusiness.com
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment