EMA Recommends Restrictions on Protelos

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Recommendation to restrict the use of Protelos/Osseor (strontium ranelate)

CHMP confirms recommendation from the PRAC

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended a restriction in the use of the osteoporosis medicine Protelos/Osseor, following an assessment of data showing an increased risk of serious heart problems. The CHMP recommended that Protelos/Osseor should only be used to treat severe osteoporosis in postmenopausal women at high risk of fracture and severe osteoporosis in men at increased risk of fracture. Additional measures, including restrictions in patients with heart or circulatory problems, were also recommended to minimise the heart risks of these medicines.

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