The European Medicines Agency recommends the suspension of Protelos. In France, the ANSM invites users to consult and practitioners not to initiate treatment.
This is another big blow for Protelos, a medicine used in the treatment of osteoporosis to reduce the risk of bone fractures. Indeed, during its monthly meeting held on January 6 and 9, 2014, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency recommended the suspension of the authorization. marketing of strontium ranelate, in other words, Protelos.
Risks of thromboembolic accidents
The French Medicines Safety Agency (ANSM) recalls that this product is authorized in all countries of the European Union, and that it was marketed in France in January 2006. But since 2007, this molecule, marketed by Laboratoires Servier, is subject to enhanced surveillance in France, in particular because of the risk of venous thromboembolic events and severe allergic skin reactions (DRESS).
France then initiated in 2011 a reassessment of the benefit / risk ratio of the product. The European health authorities had considered that it was favorable subject to new contraindications. A letter to prescribers had been sent by the ANSM reporting this European decision in April 2012.
Contraindicated in heart patients
But in April 2013, a new twist! During a routine European assessment of the benefit / risk ratio of this medicinal product, an increased risk of myocardial infarction in addition to the risks already identified was demonstrated.
The indication for strontium ranelate has since been restricted to the treatment of severe osteoporosis and contraindicated to patients at cardiovascular risk, with reinforcement of the safety information present in the summary of product characteristics (SPC) (contraindications and precautions for use).
And the Council of State refused the request for reassessment of the reimbursement rate of the product from the manufacturing laboratory. The Protelos therefore remained at the reimbursement rate of 30%, against 65% before January 2012.
ANSM asks doctors to stop initiating treatments
However, in order to accurately assess the impact of these restrictions on the population targeted by strontium ranelate, a new European arbitration was recently initiated. The available data have shown that the indication restrictions and the new contraindications do indeed reduce the cardiovascular risk, but that the population that could benefit from this treatment is difficult to identify.
According to Europe, “the population most able to benefit from osteoporosis treatment is also those at cardiovascular risk. It is difficult to establish whether the risk minimization measures put in place are applicable in clinical practice for chronic treatment. But when in doubt, the PRAC preferred to recommend the suspension of this product.
Subsequently, this PRAC recommendation will be sent to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency which will then issue its opinion during its monthly session at the end of January, then to the European Commission which will have 2 months to adopt a final decision.
Pending the final decision, the ANSM recalls its recommendations for the use of Protelos. According to her, “health professionals must take the results of the European assessment into account as of now in their daily practice and no longer initiate treatment with strontium ranelate. “Finally,” patients who are currently taking this treatment are invited to consult their doctor without urgency, “she concludes.
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