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CHMP recommends further restricting Protelos

February 22, 2014 1:46 AM UTC

EMA's CHMP recommended further restricting the use of Protelos strontium ranelate from Servier (Neuilly-sur-Seine, France) to patients who cannot be treated with other drugs approved for osteoporosis. Last month, EMA's Pharmacovigilance Risk Assessment Committee said Protelos' benefit/risk profile was no longer favorable and recommended suspending use of the drug altogether. However, CHMP said that for osteoporosis patients who have no alternative treatment, "regular screening and monitoring to exclude cardiovascular disease will sufficiently reduce" the drug's risk. CHMP said a final decision from the European Commission is expected in "due course" (see BioCentury Extra, Jan. 10). ...