FDA adds new heart warning to Sanofi's Multaq

December 19, 2011 By MATTHEW PERRONE , AP Health Writer

Federal health officials have added new safety warnings to the heart rhythm drug Multaq after company studies linked the pill to higher rates of heart attack, stroke and death in a subset of patients.

The new label, posted online Monday, highlights a study in which Multaq doubled the risk of heart-related complications in with permanent atrial fibrillation, a condition in which the heart's chambers pump out of sync. The revised label stresses that Multaq is only approved for the short-term form of the condition and a related ailment known as atrial flutter. Despite such language, doctors routinely prescribe drugs for conditions not listed on the labeling approved by the .

The label, written in cooperation with drugmaker Sanofi, instructs doctors to check patients' heart rhythm at least once every three months. If patients appear to have the permanent form of atrial fibrillation, Multaq should be discontinued. The FDA said Monday Multaq remains a beneficial drug when used appropriately.

The warning label is the latest setback for a drug that Sanofi once touted as a potential blockbuster. When first approved in 2009, Multaq was the first new drug in a decade for atrial flutter and atrial fibrillation - related in which the organ's upper chambers beat rapidly and ineffectively. Both conditions can cause stroke and death, in some cases. Multaq has been subject to a series of safety concerns, both before and after its approval in the U.S.

EU health officials have already restricted Multaq's use based on the same safety information. In September the European Medicines Agency said that the drug should only be used after other treatments for atrial fibrillation have been tried.

In the Sanofi study of more 3,200 patients there were 25 deaths in the Multaq group compared with 13 in the . All the patients in the study were older than 65 and had permanent atrial fibrillation.

Atrial fibrillation is the most common heart rhythm disorder and a frequent contributor to stroke. The French drugmaker estimates there are 2.5 million atrial fibrillation patients in the U.S., and another 4.5 million in the EU. In patients with paroxysmal, or temporary, atrial fibrillation, irregular heartbeats usually last less than 24 hours. Over time the incidents can become more frequent, developing into permanent atrial fibrillation, in which normal heart rhythm can no longer be achieved.

About 278,000 people in the U.S. have received prescriptions for Multaq as of October, according to the FDA. Sanofi reported about $224 million in sales for the drug in 2010, with most prescriptions written in the U.S.

Since last year the FDA has approved two other drugs for atrial fibrillation: Johnson & Johnson's Xarelto and Boehringer Ingelheim's Pradaxa. Both drugs are marketed as alternatives to the hard-to-use warfarin, a 60-year old drug that doctors often prescribe for atrial fibrillation. Too much warfarin can cause dangerous internal bleeding, and too little can result in strokes.

The FDA originally rejected the French drugmaker's request to approve Multaq in 2006. That was after a widely publicized study showed patients in the group taking Multaq were twice as likely to die as patients in the comparison group.

But Sanofi said the study involved patients with severe heart failure, a condition where the heart no longer pumps enough blood. Many patients in the study did not even have the irregular heart rhythm Multaq was designed to treat.

So Sanofi did another study that included 4,600 patients with but without severe heart failure. This time results were positive: Multaq helped reduce hospitalization and death from heart-related problems by 24 percent, a claim that appears on the drug's label.

already carries a black box warning, the most serious type of warning. It says that the can cause severe complications, including death, in people with recent severe heart failure and should not be used by them. Common side effects of the twice-a-day tablets include fatigue, loss of strength, diarrhea, nausea and vomiting.

Explore further: FDA cites higher death risk in Sanofi drug study


Related Stories

FDA cites higher death risk in Sanofi drug study

July 22, 2011
(AP) -- Federal health regulators are warning doctors that a heart drug from Sanofi was associated with fatal heart problems in a recently halted company study.

BUSM: Severe sepsis, new-onset AF associated with increased risk of hospital stroke, death

November 13, 2011
A recent study led by researchers at Boston University School of Medicine (BUSM) shows an increased risk of stroke and mortality among patients diagnosed with severe sepsis and new-onset atrial fibrillation (AF) during hospitalization.

Recommended for you

Opioid addiction treatment behind bars reduced post-incarceration overdose deaths in RI

February 14, 2018
A treatment program for opioid addiction launched by the Rhode Island Department of Corrections was associated with a significant drop in post-incarceration drug overdose deaths and contributed to an overall drop in overdose ...

Heroin vaccine blocks lethal overdose

February 14, 2018
Scientists at The Scripps Research Institute (TSRI) have achieved a major milestone toward designing a safe and effective vaccine to both treat heroin addiction and block lethal overdose of the drug. Their research, published ...

Study shows NIH spent >$100 billion on basic science for new medicines

February 12, 2018
Federally funded research contributed to the science underlying all new medicines approved by the FDA over the past six years, according to a new study by Bentley University.

Opioid use increases risk of serious infections

February 12, 2018
Opioid users have a significantly increased risk of infections severe enough to require treatment at the hospital, such as pneumonia and meningitis, as compared to people who don't use opioids.

Placebo pills prescribed honestly help cancer survivors manage symptoms

February 9, 2018
Long after cancer treatment ends, many continue to deal with one particular symptom that refuses to go away: fatigue. In a new study, researchers at the University of Alabama at Birmingham and Harvard Medical School have ...

Multinational companies continue to produce unregulated antibiotics in India

February 5, 2018
Millions of unapproved antibiotics are being sold in India, according to a new study by researchers at Queen Mary University of London and Newcastle University.


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.