The European Medicines Agency (EMA) has initiated a review of the strontium ranelate containing osteoporosis preparations Protelos® and Osseor®, to determine whether the cases of venous thromboembolism and drug rash with eosinophilia and systemic symptoms have an impact on their benefit-risk profile and conditions of use. Strontium ranelate is licensed in the UK (as Protelos®) for the treatment of osteoporosis in postmenopausal women to reduce the risk of vertebral and hip fractures.

The EMA press release notes that venous thromboembolism (VTE) and drug rash with eosinophilia and systemic symptoms (DRESS) are known risks of strontium ranelate. The risk of VTE was identified in clinical trials and the risk of DRESS through spontaneous reporting soon after the granting of the initial marketing authorisation, and warnings are included in the product information. The risks are addressed in the risk-management plan and have been kept under close review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).

The EMA review follows publication of a French study analysing the adverse effects associated with strontium ranelate. Please refer to the link below for further information.