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EMA's PRAC recommends suspending Protelos

January 11, 2014 2:37 AM UTC

EMA's Pharmacovigilance Risk Assessment Committee recommended suspending the use of Protelos strontium ranelate from Servier (Neuilly-sur-Seine, France) after concluding the osteoporosis drug's benefit/risk profile was no longer favorable. PRAC said Protelos had a "modest" effect on osteoporosis and noted that for every 1,000 patient-years there were four more cases each of serious heart problems and blood clots or blockages of blood vessels with the drug vs. placebo. PRAC also said the product is associated with a number of other risks, including serious skin reactions, disturbances in consciousness, seizures, liver inflammation and reduced number of blood cells. ...