Quoted from http://www.reuters.com/article/2011/09/22/sanofi-idUSL5E7KM21Y20110922
EU agency calls for restrictions on Sanofi's Multaq
Thu Sep 22, 2011 12:58pm EDT
By Caroline Jacobs
PARIS, Sept 22 (Reuters) - Risks of liver, cardiovascular or lung issues stemming from Sanofi's Multaq irregular heart beat drug mean its use should be restricted, Europe's drug regulator said on Thursday following a safety review.
The decision could raise further pressure on Sanofi to speed up the replenishment of a drug pipeline which has been drastically diminished after a top-to-bottom review.
Following a monthly meeting, the regulator's Committee on Medicinal Products for Human Use (CHMP) in London recommended the drug should only be prescribed "after alternative treatment options have been considered".
Patients taking Multaq, once touted as a blockbuster, are recommended to have their treatment evaluated by their doctor at their next scheduled appointment, the panel of the European Medicine's Agency said in a statement.
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