Local Risk Management Plan for Strontium Ranelate (Protos®, Servier)

Servier would like to inform healthcare professionals about the risk management plan (RMP) for strontium ranelate (Protos®) that has been developed to mitigate the risks of serious hypersensitivity skin reactions seen locally. Protos® is indicated for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures. Doctors are advised to monitor patients closely for early signs and symptoms of serious skin reactions and provide patients with a copy of the Patient Medication Guide (PMG). Doctors are also encouraged to enrol their patients in the Patient Care Program (PCP) with the main objective of supporting patients in the close monitoring of serious skin reactions during the early stage of the treatment. For further details about the PMG, PCP and other aspects of the RMP, please refer to the letter.