Following a European review, the Medicines and Healthcare products Regulatory Agency (MHRA) will be issuing updated advice to healthcare professionals that Protelos, used to treat severe osteoporosis in post-menopausal women and men with a high risk of fracture, should only be prescribed to patients who do not have a history of heart problems and if the patient is unable to take other medicines for this condition.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and Pharmacovigilance Risk Assessment Committee (PRAC) carried out a review into Protelos because of study data which suggested an increased risk of heart problems.

The review concluded that there was no evidence of an increased risk of cardiovascular problems in patients who did not have a history of heart or circulatory problems and that Protelos could still be used in patients who do not have an alternative treatment. However, the CHMP recommended that patients taking Protelos should be monitored regularly by their doctor and treatment should be stopped if heart problems occur.

The EMA will be updating the patient information leaflet for Protelos to reflect the prescribing guidelines and small risk of heart problems and blood clots.

Dr Sarah Branch, Deputy Director of the MHRA’s Vigilance and Risk Management of Medicines Division, said:

“The safety of patients is a priority which is why the EMA have reviewed the available data in depth. 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.


Posted on the UK MHRA website on 21 February 2014