Afssaps refers Protelos to EMA for re-evaluation as a treatment for Post Menopausal Osteoporosis

The French regulatory agency Afssaps has decided not to suspend Protelos (strontium ranelate),the Post Menopausal Osteoporosis drug from Servier Labs. Afssaps has referred the drug to EMA and asked for a re-evaluation. There are safety concerns due to cases of venous thrombo-embolism in patients over 80 years of age (who have additional risk factors) and cases of DRESS (dry rash with eosinophilic systemic syndrome).Afssaps recommends that patients be prescribed with Protelos if they are under 80 years of age and cannot take bisphosphonates and have a high risk of fractures. Protelos has shown efficacy in clinical trials in reducing spine and hip fractures.