The European Medicines Agency recommends that PROTELOS®/OSSEOR® remain available with further restrictions

21/02/2014

Suresnes, 21 February 2014 - Servier would like to inform healthcare professionals that the European Medicines Agency (EMA) has concluded its review of Protelos®/Osseor® benefits and risks and has recommended maintaining the European Marketing Authorization with further restrictions of the indication1 and monitoring recommendations.

The Committee for Medicinal Products for Human Use (CHMP), which has worked in close collaboration with the Pharmacovigilance Risk Assessment Committee (PRAC), has considered the current contra-indications2 sufficient to minimise the cardiovascular risk. In addition, the CHMP has noted that available data do not show any evidence of an increased risk in patients who did not have a history of heart or circulatory problems.

In practice, cardiovascular risk monitoring of patients will be increased and information for healthcare professionals and patients will be strengthened.

The beneficial effect of Protelos®/Osseor® in preventing fractures, including in patients at high risk of fracture, is confirmed.

Under these conditions, the EMA considers that the benefit-risk ratio is positive and that Protelos®/Osseor® represents a necessary alternative in the treatment of osteoporosis.

Servier is informing all health agencies in countries where Protelos®/Osseor® is registered of these changes and is conducting further research to demonstrate the effectiveness of the new measures.

Servier will send detailed information to healthcare professionals informing them of the updated recommendations for use in the coming days and will also provide educational materials for prescribers and patients.

1 Protelos®/Osseor® is now indicated in the treatment of severe osteoporosis in postmenopausal women and adult men at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance. In postmenopausal women, Protelos®/Osseor® reduces the risk of vertebral and hip fractures.

2 Protelos®/Osseor® is contraindicated in patients with established, current or past history of venous thromboembolic event, ischemic heart disease, peripheral arterial disease, cerebrovascular disease, and/or in case of uncontrolled hypertension or temporary or permanent immobilisation.