Quoted from http://www.reuters.com/article/idUSTRE70H7NJ20110118
Sanofi expects EU to ask for patient alert on Multaq
By James Regan
PARIS | Tue Jan 18, 2011 5:35pm EST
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.