PARIS (Reuters) - French drugmaker Sanofi-Aventis expects European medical authorities to request it to alert doctors about possible safety risks related to its Multaq heart drug, following a similar move in the United States.
The U.S. health regulator said on Friday it had received several reports of liver damage in patients taking Multaq. It was “continuing to review reports of possible adverse events and drug interactions” with Multaq.
A Sanofi-Aventis spokesman said on Tuesday the company was working closely with all healthcare authorities and reiterated that no causal link had been formally established between liver damage and the medicine, which treats irregular heartbeat.
“We expect in the coming days the recommendation from the EMA (European Medicines Agency) to give information to patients and healthcare professionals in Europe as it has been done in the United States,” the spokesman said.
Sanofi confirmed on Friday two patients suffered liver failure after taking the drug, which became available in the U.S. in July 2009 and in Europe early last year.
La Tribune newspaper said the Committee for Medicinal Products for Human Use, part of the EMA, would ask Sanofi to write to healthcare professionals in Europe about Multaq’s use.
“We are also going to recommend a change in the wording of the instructions on the product,” La Tribune quoted the EMA as saying.
At the EMA no one was immediately available to comment.
Multaq is among Sanofi’s most important new products as it loses out on sales due to generic challenges on several key drugs. Analysts expect sales of Multaq, whose generic name is dronedarone, to reach $1.35 billion by 2014, consensus forecasts from Thomson Reuters Pharma show.