Multaq Is Risky, Says FDA; Causes Cardiovascular problems or even Death

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Photo Courtesy: healthandsafetywatch.com

The FDA issued a request to healthcare professionals to include a warning or deny prescription of Multaq to patients who suffer from Permanent Atrial Fibrillation and they cannot or do not choose to convert into normal sinus rhythm (permanent AF).

Multaq (Dronadarone) is said to double the rate of cardiovascular death, cause heart failure and probably also cause stroke.

Following a termination of a recent series of PALLAS and ATHENA trials because of a high number of cardiovascular incidences in the group treated exclusively with Multaq as compared to another group for which placebo was administered, the FDA issued the warning based on this data.

Interestingly, Multaq was an approved prescription and was considered as an alternative to amiodarone. It was primarily used for the treatment of atrial fibrillation in treatments that help patients maintain a normal rhythm or use electric shock treatments to restore the heart to a normal rhythm.

In a much detailed, explicit statement, the FDA also stated that all healthcare professionals, surgeons, and doctors dealing with cardiac or cardiovascular treatments should first check for the heart rate or the cardiac rhythm using an electrocardiogram (ECG), one every three months. Multaq should not given or stopped if patients are found to be in Atrial Flutter (AF).

According to the Medilexicon website, Multaq is “a benzofuran derivative with anti-arrhythmic properties””. Futher, “Multaq is specifically indicated to reduce the risk of cardiovasulcar hospitalization in patients with Atrial Flutter (AF)”. Multaq is available as a 400mg tablet and is primarily meant for oral administration. The recommended intake is an initial dose of 400mg, twice a day along with meals.

There are also many side effects associated with Multaq. Some of the common ones are diarrhea, nausea, asthenic conditions, abdominal pain and skin infections.

The warning from the FDA now comes in a box highlighting the results of the study, according to a recent release from the Washington Post . This warning comes in co-operation with Sanofi – the drug maker for whom this is indeed a set back since Multaq was seen as a blockbuster achievement for Sanofi. As of today, 278,000 U.S residents have received prescriptions for Multaq, amounting to $224 million in sales within the U.S, according to the FDA.

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