European Medicines Agency recommends further restrictions for use of Osseor and Protelos
The European Medicines Agency (EMA) has concluded its review of Protelos/Osseor and has recommended further restricting the use of the medicine to patients who cannot be treated with other medicines approved for osteoporosis. These medicines should only be used in patients who cannot take other medicines for osteoporosis treatment. In addition, doctors should continue to regularly monitor the patients every 6 to 12 months and the Protelos/Osseor should be stopped if the patient develops ischaemic heart disease, peripheral arterial disease or cerebrovascular disease, or if hypertension is uncontrolled or angina. According to the aforementioned, patients with heart problems or peripheral arterial disease in disease history should not use this medicines.
In arriving at its conclusions, the CHMP noted that study data showed a beneficial effect in preventing fractures, including in patients at high risk of fracture. In addition, available data do not indicate an increased cardiovascular risk in patients not having hear or circulation problem in their medical history. According to the CHMP the cardiovascular risk in patients taking Protelos/Osseor may be minimised by limiting the use of these medicines only to patients not having heart or circulation problems in their medical history and cannot take other medicines for osteoporosis. However, additional risk minimisation measures should be introduced, including education materials for prescribers to ensure that only patients in whom the use of these medicines is justified. The marketing authorisation holder should carry out additional studies to prove the effectiveness of these risk minimisation measures.
This final recommendation of the EMA’s Committee for Human Medicinal Products (CHMP) follows the initial recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) on suspension of these medicines due to their increased cardiovascular risk. The PRAC actively participated in this CHMP’s recommendation and it was concluded that these medicines should remain available for preventing fractures in patients under high risk, who did not have heart or circulation problems in their medical history.
Information to patients
Protelos/Osseor should only be prescribed for preventing fractures in post-menopausal women and men with severe osteoporosis who have a high risk of fracture and cannot be treated with other medicines approved for osteoporosis. Before starting treatment, your doctor will assess your risk of heart disease and high blood pressure and continue to check your risk at regular intervals during treatment. You should not take Protelos/Osseor if you have or have had heart or circulatory problems such as stroke, heart attack, or obstruction of the blood flow in the arteries. Your treatment with Protelos/Osseor will be stopped if you develop heart or circulatory problems during treatment. If you have further questions, speak to your doctor or pharmacist.
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 to treat severe osteoporosis in postmenopausal women and men at high risk of fracture, for whot treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance. Protelos/Osseor must not be used in patients with established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease, or those with uncontrolled hypertension. Doctors should continue to 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 starting treatment and on a regular basis thereafter, generally every 6 to 12 months. Protelos/Osseor should be stopped if the patient develops ischaemic heart disease, peripheral arterial disease or cerebrovascular disease, or if hypertension is uncontrolled. Doctors should review their patients currently on Protelos/Osseor as necessary.