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Use of strontium ranelate should be suspended because of heart risk

Strontium ranelate (Protelos) should no longer be used to treat osteoporosis, according to new recommendations from the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC).

In April 2013, the PRAC advised restricting the use of strontium ranelate to patients with severe osteoporosis who have a high risk of fracture. It also recommended that the medicine should not be used by patients with uncontrolled hypertension or current or past history of ischaemic heart disease, peripheral arterial disease or cerebrovascular disease, because new data revealed an associated risk of heart problems. This restriction was backed by the EMA’s Committee for Medicinal Products for Human Use (CHMP) later that month.

The latest review found that for every 1,000 patient-years there were four more cases of serious heart problems (including heart attacks) and four more cases of blood clots or blockage of blood vessels with strontium ranelate compared with placebo.

In addition, strontium ranelate is associated with other risks, including serious skin reactions, disturbances in consciousness, seizures, liver inflammation and a reduced number of blood cells.

The PRAC concluded that the balance of benefits and risks for strontium ranelate is no longer favourable and recommended that its use should be suspended until new data show a favourable balance in a defined patient group.

These latest recommendations will now be sent to the CHMP, which is expected to issue the agency’s final decision at its next meeting later this month (January 2014).

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11132692

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