4/15/2013 8:12:21 AM
EMA advisors have called for a restriction on the use of Servier's osteoporosis drug Protelos/Osseor (strontium ranelate) after linking it to serious potential side effects. The move comes after their analysis of clinical trial data showed an increased risk of heart problems, including heart attack. The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) said the key data came from studies involving around 7,500 patients and showed an increased risk of a heart attack in postmenopausal women taking Protelos/Osseor compared with those taking placebo. Although there was no increase in deaths, the PRAC said, “the data were of concern given other serious risks” identified in a previous EMA review last year.
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