Protelos recommended for suspension in EU due to blood clotting problems-Servier
European regulators have recommended suspending Protelos (strontium ranelate) from Servier because of the risk of serious heart problems and blood clots. The European Medicines Agency had already restricted the use of Protelos - also known as Osseor - in April 2013 but its pharmacovigilance committee said the drug should no longer be used to treat Osteoporosis at all.
The decision follows an analysis which found that for every 1,000 patient-years there were four more cases of serious heart problems, including heart attacks, and four more cases of blood clots among patients taking the drug than those on placebo.
The recommendation will now be sent to the agency's Committee for Medicinal Products for Human Use, which is expected to issue a final opinion at its January 20-23 meeting.
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