A panel for the European Medicines Agency recommended that a strontium ranelate, a treatment for osteoporosis, be restricted because of possible increased risk of cardiac problems.
The EMA’s Pharmacovigilance Risk Assessment Committee evaluated data on Protelos and Osseor, identical drugs that were approved in 2004 as a treatment for postmenopausal women with osteoporosis to reduce the risk for bone fractures. Clinical studies that included more than 7,500 patients have shown an increased risk of MI in postmenopausal women who were taking Protelos and Osseor compared with a placebo. A previous review also found risks of blood clots.
The committee recommended that prescribing information should be revised while an evaluation is being done. It suggested that the drug only be used in cases of severe osteoporosis in postmenopausal women and men who are at increased risk of bone fractures. Patients with ischemic heart disease (MI or angina) or a history of ischemic heart disease; peripheral artery disease; cerebrovascular disease; or uncontrolled hypertension should not take Protelos and Osseor.
The recommendations were sent to the Committee for Medicinal Products for Human Use, which will provide a final opinion at a meeting April 22-25.