EMEA adds warnings in the prescribing information of Strontium Ranelate (Protelos)
2007-11-20
On November 16, 2007, the European Medicine Agency (EMEA), the European's equivalent to the Saudi Food and Drug Authority (SFDA), agrees on the inclusion of warnings concerning the risk of severe hypersensitivity reactions in the prescribing and patient information for strontium ranelate, as an urgent measure .
Strontium ranelate (Protelos) is used for treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.