Heart rhythm drug Multaq may cause liver injury

Heart rhythm drug Multaq may cause liver injury
Tuesday, March 15, 2011 - 17:00 in Health & Medicine
The maker of a drug Multaq used to treat an abnormal heart rhythm issued a warning about the potential for liver injury in patients taking the medication.
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Heart rhythm drug Multaq may cause liver injury
March 15
The maker of a drug used to treat an abnormal heart rhythm issued a warning Tuesday about the potential for liver injury in patients taking the medication.
Sanofi-Aventis Canada Inc., working in collaboration with Health Canada, said there have been reports of liver dysfunction in some patients treated with Multaq, which is taken to control the heart-rhythm condition atrial fibrillation.

Patients taking Multaq should immediately report to their doctors any symptoms suggestive of liver injury, including loss of appetite, nausea, vomiting, unusual fatigue, right upper stomach area pain or discomfort, yellowing of the skin or whites of the eyes (jaundice), unusual darkening of the urine, or itching.

Patients should consider obtaining periodic liver function tests, the company advised.
Cases of serious liver injury or other serious or unexpected side-effects in patients taking Multaq (dronedarone hydrochloride) should be reported to Health Canada via its website or by calling 1-866-234-2345.
http://www.cbc.ca/news/health/story/2011/03/15/multaq-liver-injury.html


FDA warns of possible liver damage of heart drug Multaq
By admin, on January 18th, 2011
The US FDA on Jan. 14 issued a safety announcement about reports of rare but severe liver injury in patients taking Sanofi-Aventis’ Multaq (dronedarone), including two patients who had acute liver failure that required transplantation.

Multaq is used for the treatment of abnormal heart rhythm in patients who have those symptoms for the past 6 months, according to the FDA.
The announcement warned physicians and patients to be alert for signs and symptoms of liver injury or toxicity, including anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching.

Physicians are encouraged to consider ordering periodic hepatic serum enzymes, particularly during the initial 6 months of treatment with Multaq.

Since Multaq got it approval in 2009, it has been prescribed at least a million times. Bottles of the drug already carry a warning that says that it can have severe complications. The label’s adverse reactions and warnings and precautions sections are being updated to include information about the potential risk of liver injury.

Sanofi had later on sent a letter to the US and while talking to the press, company spokesman Jean-Marc Podvin had assured that patients’ safety was the priority for Sanofi.