This is a scary situation. You have a heart problem that could kill you, but one of the options they give you actually increases that possibility. What was the FDA thinking?.
Regulators with the Food and Drug Administration have warned that Multaq, a cardiac drug Sanofi
, has been linked with fatal heart problems in a clinical trial the company recently ended.
In the study involving 3,000 patients, 32 who were taking Multaq died from cardiac-related problems compared with 14 who were taking a placebo. In all, nearly twice as many people suffered heart attacks, strokes and death than those in the placebo control group.
Multaq is prescribed to control atrial fibrillation, the most common type of irregular heartbeat which is found in about 2.2 million Americans. It is a condition in which the primary electrical impulse that causes the atria - the two upper chambers of the heart - to contract instead fires erratically, causing several other nodes, or electrical impulse points, to fire instead.
The resulting erratic firing causes the atria to become inefficient, and heart rates can climb to about 150. The condition can lead to heart attacks or, more commonly, stroke, because blood does not flow through them as quickly, causing clots.
The Sanofi study involved patients who were 65 years old or older and who were afflicted with atrial fibrillation, or A-fib. The FDA approved Multaq for use in such patients in 2009 for a short-term type of the arrhythmia, as well as an associated condition known as atrial flutter.
As of June, some 241,000 patients nationwide had been prescribed twice-a-day Multaq. And while the FDA hasn't ordered the drug to be taken off the market, the agency is advising patients who are on it to talk to their doctor about the findings.
Despite the FDA warning, Sanofi says it believes the drug is still safe for use.
"It is important that Multaq only be used in patients with non-permanent atrial fibrillation or atrial flutter, as per the current U.S. label," a company spokesman told The Associated Press in an email.
The European Medicines Agency, which is similar in makeup and operation to the U.S. FDA, is also looking at the safety of Multaq, though that agency has yet to issue any warnings.
Recent studies have questioned the FDA's process for approving new drugs.
One study, published in the Journal of American Medical Association (JAMA) found that only about half of the drugs
put on the market over the past decade had proper data in place for the FDA, yet the agency approved them anyway, while others - like aripiprazole, used to treat bipolar disorder - were approved after only limited clinical trials.