Cardiologist Urges Patients Using Multaq: Contact Physicians

COURT HOUSE — As a result of a Food and Drug Administration warning issued July 22 about the atrial fibrillation drug Multaq, cardiologist Dr. Suketu Nanavati has contacted at least 20 of his patients to stop taking the medicine and has placed them on other medication.
Nanavati urged others to contact their cardiologists or physicians regarding continued use of the drug.
Patients should not, on their own, stop taking the drug, he said, and has urged them to not to delay contacting their doctors.
The FDA announced that a clinical trial of Multaq was stopped because the drug doubled the risks of death, stroke and heart failure in cardiac patients.
The drug was approved for the treatment of paroxysmal atrial fibrillation, persistent atrial fibrillation or atrial flutter.
The federal agency is now trying to determine how the clinical test indications can be applied to those taking the drug.
Multaq was placed on the market in 2009 after a clinical trial, ATHENA, indicated that it decreased cardiovascular deaths by 30 percent and hospitalizations by 25 percent in those with non-permanent atrial fibrillation and atrial flutter.
The FDA is urging physicians not to prescribe Multaq to those suffering from permanent atrial fibrillation.
It is also attempting to determine whether the PALLAS (Permanent Atrial fibrillation Study) trial results are applicable to those taking Multaq for paroxysmal atrial fibrillation, persistent atrial fibrillation or atrial flutter
The PALLAS trial used Dronedarone on top of standard therapy. Over a wide range of patients, it compared the use of Multaq, 400 mg was taken twice daily with a placebo in a test of over 10,000 patients suffering permanent atrial fibrillation. The test started in 2010.
Multaq was developed by Sanofi–Aventis.
Multaq is an anti-arrhythmic drug that affects heartbeat rhythms.
Also, two patients in Germany who were on Multaq, developed liver damage and needed liver transplant. One of Nanavati’s patients had liver damage but the abnormality was reversed after stopping the drug.
According to the published reports, Jean-Pierre Lehner, Sanofi chief medical officer, stated the firm was alerting all regulatory agencies about the test results.
“Nobody should panic,” said Nanavati. “Make a call to your cardiologist or doctor who will evaluate your situation.”
Contact Campbell at (609) 886-8600 Ext 28 or at: al.c@cmcherald.com