Information to healthcare professionals

Healthcare professionals in the EU Member States will receive a letter informing them of the updated recommendations on the use of Protelos/Osseor. The letter will advise them of the following:

Protelos/Osseor should only be used for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture and severe osteoporosis in men at increased risk of fracture.

Protelos/Osseor is contraindicated in patients with a current or past history of ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease, or in patients with uncontrolled hypertension.

Treatment with Protelos/Osseor should only be started by a physician experienced in the treatment of osteoporosis.

The physician should base their decision to prescribe Protelos/Osseor on an assessment of the individual patient’s risks. The patient’s risk of developing cardiovascular disease should be evaluated before and at regular intervals during treatment

Treatment should be stopped if the patient develops ischaemic heart disease, peripheral arterial disease or cerebrovascular disease or if hypertension becomes uncontrolled.Information to healthcare professionals.