Dear Health Care Professionals letter on new contraindications and revised warnings for medicinal products containing the active substance strontium ranelate (Osseor/Protelos)
Servier Pharma d.o.o. company which is the marketing authorisation holder for finished medicinal products Osseor 2 g granules for oral suspension and Protelos 2 g granules for oral suspension, has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care professionals on new contraiondications and revised warnings for medicinal products containing the active substance strontium ranelate.
In March 2012, the European Medicines Agency (EMA) completed a review of benefits and risks of medicines with the active substance strontium ranelate that are used to treat osteoporoses. The review was initiated with the aim to reassess the risk of venous tromboembolism (VTE) and severe allergic skin reactions that had been known known for strontium ranelate and included in the Summary of Product Characteristics and Patient Information Leaflet. EMA concluded that the benefits outweigh the risks of strontium ranelate, but concluded that new contraindications should be included and warnings revised, in order to better manage the risks associated with its use.