EMEA Recommends Changes In The Product Information For Protelos/Osseor Due To The Risk Of Severe Hypersensitivity Reactions

The European Medicines Agency (EMEA) agrees on the inclusion of warnings concerning the risk of severe hypersensitivity reactions in the prescribing and patient information for Protelos/Osseor, as an urgent measure. These products, which contain strontium ranelate, were approved in the European Union in September 2004 for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures. [click link for full article]

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Filed under: Dermatology on November 18th, 2007