Risk of severe hypersensitivity reactions from strontium ranelate-containing medicine The European Medicines Agency (EMEA) has recommended immediate inclusion of strong warnings concerning the risk of severe hypersensitivity reactions in the summery of product characteristics and patient information leaflet patient for Protelos® and Osseor®, which contain strontium ranelate. The products were approved in the EU in September 2004 for the treatment of postmenopausal osteoporosis.
Up to now, there have been 16 cases of the so-called DRESS syndrome (Drug Rash with Eosinophilia Systemic Symptoms), which is a severe allergic reaction with rashes, fever and symptoms from internal organs, among patients treated with Protelos®/Osseor®. Hereof, two deaths have been reported to the EMEA following a total of 570,000 patient years of exposure. DRESS is a rare but serious condition, which has been described with some other drugs such as anticonvulsants, allopurinol, minocycline, abacavir and sulfasalazine. The reported serious reactions started between 3 and 6 weeks of the initiation of the treatment, with rash accompanied by fever, swollen glands and damage to liver and kidney.
Having assessed the available data, the EMEA's Committee for Medicinal Products for Human Use (CHMP) recommended that the product information be updated in a rapid procedure to include warnings on severe hypersensitivity syndromes, including DRESS, Stevens Johnson-Syndrome and musculoskeletal pain.
Patients are advised to stop treatment with Protelos® or Osseor® when a rash occurs and to seek medical advice.
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