Sanofi-Aventis, the pharmaceutical giant may face numerous lawsuits as its cardiac arrhythmia drug Multaq is being linked to liver damages. Researches also indicate that Multaq, which contains dronedarone as main active ingredient, causes liver injuries and heart-related side effects.

Facts About Multaq

Multaq is a drug for treatment of cardiac arrhythmia. It is manufactured by Sanofi-Aventis, the Paris based pharmaceutical giant. The U.S. Food and Drug Administration approved Multaq tablets to help maintain normal heart rhythms in patients, who have a history heart rhythm disorders such as atrial fibrillation or atrial flutter. It contains Dronedarone as main active ingredient. Clinical trials have shown that Multaq reduced cardiovascular hospitalization or death by 24 percent. It has shown positive result especially in patients having history of atrial fibrillation. Heart rhythm disorders such as atrial fibrillation and atrial flutter could prevent pumping of blood out of the heart.

It has been linked with liver damages since its production started. FDA had asked for a boxed warning asking patients to not use this drug in severe heart failure patients. Later FDA also asked the manufacturers to add additional warning to reflect the increased health risks, including death, for some patients with irregular heart rhythms. FDA had asked patients who have permanent atrial fibrillation (AF), a type of abnormal heart rhythm to not use this drug.

The U.S. Food and Drug Administration (FDA) approved the drug Multaq in July 2009 for treatment of cardiac arrhythmia. It comes in 400 mg oral tablets.

Multaq Side Effects, Which Could Lead To Lawsuits

FDA has received reports of liver damage due to use of Multaq, since the circulation of this drug started. Some reports indicated that some patients needed liver transplant too. FDA asked to add additional warning on Multaq labels to inform health care professionals and consumers about risks associated with this drug. FDA also issued a Drug Safety Communication on January 14, 2011, to warn that Multaq had caused several cases of hepatocellular liver injury and hepatic failure.

Use of Multaq could yield many side effects such as malaise, fatigue, itching, yellow eyes or skin, jaundice, nausea or vomiting, fever, dark urine, abdominal pain, light-colored stools, loss of appetite, which could be a sign of liver damage or liver failure.

Another drug for treatment of atrial fibrillation, Cordarone had earlier showed serious side effects, and this led to development of Multaq. But Multaq is also said to cause severe side effects such as liver damages and liver failure. It is also said to increase the risk of cardiovascular events, including death, in permanent atrial fibrillation (AF) patients.

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use has also restricted use of Dronedarone, the main active ingredient of Multaq. It restricted the use of Dronedarone to patients only after other treatment options have been considered.

All these favor the fact that Multaq or dronedarone could cause liver damages or liver failure. This could lead to many lawsuits, which will get a boost as FDA also supports the fact that Multaq could cause harm to liver in patients using this medicine.