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Published on 10 October 2011

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Afssaps asks EMA for Protelos® risk assessment

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Afssaps has asked the European Medicines Agency (EMA) to perform a new benefit/risk analysis of strontium ranelate (Protelos®).

Pending the outcome of this reassessment, Afssaps has sent a warning to health professionals that they should restrict the use of this drug in patients with intolerance to bisphosphonates or at high risk of fractures.

Protelos® has been marketed in France since January 2006 and is indicated in the treatment of osteoporosis in postmenopausal women.

Approximately 220,000 in France are treated with the drug, but major adverse effects have been identified, including the risk of thromboembolisms and allergic reactions, particularly in those over 80-years-old.

These concerns were highlighted first in 2007 by the national system of pharmacovigilance.

Patient information leaflets have since been modified to inform patients they must discontinue treatment immediately and permanently if they develop a rash.

Pharmacovigilance data show the persistence of serious adverse effects, which may be life-threatening and occur particularly in patients presenting risk factors and over 80-years-old.

Afssaps



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