New prescribing advice for Protelos

27 April 2012

A review into the safety of strontium ranelate (Protelos) with regard to venous thromboembolism (VTE) and serious skin reactions has been completed by the EMA.

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The agency has recommended that the postmenopausal osteoporosis treatment not be prescribed to patients with VTE or a history of VTE, or to patients who are temporarily or permanently immobilised. Since the risk of VTE is also increased in the elderly, prescribers should re-evaluate the need for continued treatment with strontium ranelate in patients over 80 years of age.

Patients must stop treatment immediately if a severe allergic reaction occurs, such as skin rash, and treatment should not be reinitiated.

Patients should be made aware of the timings and symptoms of potential serious skin reactions to strontium ranelate, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug rash with eosinophilia and systemic symptoms (DRESS). The risk of SJS and TEN is highest within the first few weeks of treatment; DRESS occurs most commonly after around 3–6 weeks of treatment.

View Protelos drug record

Further information: Servier Laboratories Ltd