14.01.2014
To the attention of healthcare professionals
On 10 January 2013, the European Medicines Agency (EMA) issued a press release on the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend the use of strontium ranelate-containing medicines Protelos and Osseor.
The PRAC conducted a review of the benefits of these medicinal products, as well as a review of their known risks (myocardial infarction, venous thromboembolism, severe cutaneous reactions) and concluded that the benefit-risk balance for these products is no longer positive, recommending that the use of Protelos/Osseor be suspended until new data attesting a positive benefit-risk balance for a limited group of patients is available.
While in April 2013 the PRAC recommended the restriction in the use of strontium ranelate, following a routine assessment of its benefit-risk balance, in January 2014, following an in-depth review of its safety profile, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee recommended the suspension of its use in the treatment of osteoporosis.
At this stage, until new data becomes available confirming usefulness of this product for a certain population segment is available and until issuance of a European Commission Decision based on the final opinion of EMA’s Committee for Medicinal Products for Human Use (CHMP) to be formulated after its meeting of 20-23 January 2014, physicians are advised to take particular care when prescribing these medicinal products.