Indicated in postmenopausal women to reduce the risk of fractures, Protelos is subject to a new prescription restriction.
The European Medicines Agency (Ema) announced on Tuesday new restrictions on the use of Protelos, indicated for the treatment of osteoporosis in postmenopausal women or in men to reduce the risk of vertebral and hip fractures . “New data indicate an increased risk of myocardial infarction,” says Ema.
Marketed in France in 2006 by Servier laboratories, Protelos has been the subject since 2007 of enhanced surveillance, particularly because of the risk of venous thromboembolic events and severe allergic skin reactions. This is why at the initiative of France, the drug was reassessed in 2011 at European level. However, the Committee for Medicinal Products for Human Use of the European Medicines Agency concluded in March 2012 that Protelos still remained positive for the risk. Result, even if the indication of the product did not change, new contraindications were brought.
In a letter addressed to doctors in April 2012, Servier laboratories specified that Protelos was “now contraindicated in patients presenting, an episode or having a history of thromboembolic venous events (EVT), including deep vein thrombosis and pulmonary embolism “. But also victims temporary or permanent immobilization due, for example, to post-surgical convalescence or prolonged bed rest.
But, while things could have ended there for the drug, recent data highlight an increased risk of myocardial infarction without impact on mortality in patients taking Protelos, justifying a review of the drug at European level. .
And while awaiting the results, the National Medicines Safety Agency recommended in April 2013 “to reserve Protelos for patients with severe osteoporosis and not to use it in patients with a cardiovascular risk factor” .
Ema has just further restricted the conditions for prescribing the drug. “Protelos is now contraindicated in patients with or with a history of ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease as well as in patients with uncontrolled hypertension,” the statement said.
For the European Agency, “this treatment should therefore be initiated only by a doctor experienced in the diagnosis and treatment of osteoporosis and that the decision to prescribe Protelos must be based on an individual assessment of all the risks. for each patient ”. Protelos is now indicated for the treatment of severe osteoporosis in postmenopausal women and in men at high risk of fracture.
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