The osteoporosis drug strontium ranelate (Protelos) should only be given to patients who have no history of heart problems and have no alternative treatment, the MHRA has warned (February 21).
The European Medicines Agency (EMA) had concluded that the benefits of the drug continued to outweigh the risks but there should be restrictions on its use, following an "in-depth" review of the drug's cardiovascular risks, the MHRA said on Friday.
Strontium ranelate should only be given to osteoporosis patients who have no history of heart problems and have no alternative treatment, says the MHRA
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The EMA's Pharmacovigilance Risk Assessment Committee recommended in January that the drug should be suspended after finding that for every 1,000 patient-years of treatment with strontium ranelate there were four additional serious heart problems and four more cases of thromboses, whereas the drug had only a ‘modest' benefit in terms of fracture prevention.
But the EMA had concluded that drughad a "beneficial effect" in preventing fractures and there was no evidence of an increased risk of cardiovascular problems in patients who did not have a history of heart or circulatory problems, it said on Friday.
Patients with a history of heart and circulatory problems, such as stroke and heart attack, should not take the drug and those who did should be monitored every six to 12 months and taken off the drug immediately if heart or blood pressure problems occur, it said.
The EMA would be updating the patient leaflet for the drug to reflect the risks, the MHRA said. Sarah Branch, deputy director of the MHRA's Vigilance and Risk Management of Medicines Division, said patients who were currently taking Protelos for severe osteoporosis should continue to take their medicine and contact their doctor if they had any questions.
● The EMA has also recommended restrictions on the use of methysergide, because of fears it could lead to organ and tissue damage.
The migraine reliever was linked to fibrosis, a condition in which scar tissue accumulated in body organs, potentially damaging them, in a review by the agency's Committee for Medicinal Products for Human Use (CHMP), the EMA announced on Friday (February 21).
As a result, the drug, which had shown to be clinically effective, was now only reserved where first-line medication has failed for severe, long-lasting migraines and cluster headaches, the EMA said. Treatment should only be started and supervised by a specialist migraine doctor, who should screen patients for fibrosis every six months, it said.
The CHMP's recommendations will be sent to the European Commission, who will then issue a final, legally-binding decision.