MHRA updates advice for osteoporosis drug use
Healthcare professionals treating severe osteoporosis in women who have gone through the menopause and men with a high risk of fracture are to be given updated advice on the use of Protelos.
The Medicines and Healthcare products Regulatory Agency (MHRA) will be advising that the drug should only be prescribed to patients who do not have a history of heart problems and cannot take an alternative.
The advice comes in the wake of a review conducted by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and Pharmacovigilance Risk Assessment Committee (PRAC).
It was carried out after studies suggested Protelos increased the risk of heart problems.
The review concluded that there was no evidence that it raised the risk of heart problems in patients who did not already have a history.
It said the drug could still be used for patients who are unable to take other medicines for their conditions.
But the review said doctors should closely monitor patients taking Protelos and stop using it if any heart problems occurred.
The deputy director of the MHRA’s Vigilance and Risk Management of Medicines Division, Dr Sarah Branch, said the EMA had carried out the review as patient safety was the priority.
She added: “Their conclusion is that the benefits of this medicine continue to outweigh the risks but that there should be restrictions on its use.
“Patients who are currently taking Protelos for severe osteoporosis should continue to take their medicine and should contact their doctor if they have any questions. Doctors should review their patients currently on Protelos as necessary.”
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