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Health Canada Reviews Heart Safety of Drug Used for Abnormal Heart Rhythm

From Canadian Press DataFile (July 21, 2011)

TORONTO _ Health Canada is reviewing the safety of the prescription drug Multaq, which is used to reduce the risk of hospitalization for people with an abnormal heart rate.

It notes that the drug company Sanofi has stopped a clinical trial because of a higher number of severe heart-related problems in people taking the drug, compared to those not taking it.

The trial had been exploring the use of Multaq in patients over 65 with permanent atrial fibrillation, in addition to other forms of heart disease.

In Canada, Multaq is authorized only for patients with various forms of intermittent atrial fibrillation.

Health Canada says it's evaluating information on Multaq and the potential for an increased risk of problems such as heart attack and stroke.

It says it will take regulatory action as needed when the review is complete.

"This could include updating the labelling information with new safety information," the agency said in a statement Thursday.

"Health Canada will keep health professionals and the public informed of new safety recommendations coming out of the review as appropriate."

Sanofi and Health Canada put out a warning in March on Multaq and the risk of liver injury.

At the time, they advised patients using Multaq to report any symptoms possibly suggesting liver injury to their doctor.

These include loss of appetite, nausea, vomiting, unusual tiredness, pain or discomfort in the right upper stomach area, jaundice, unusual darkening of the urine or itching.

Health Canada says patients with concerns about Multaq should talk to their doctor and report any adverse reactions to the agency's Canada Vigilance Program.


Posted: July 2011