Medicines and Healthcare products Regulatory Agency (MHRA) has recently published a Drug Safety Update article with advice for healthcare professionals on Prolia (denosumab 60mg).
Denosumab 60mg (Prolia) is authorised for use only in adults (aged 18 years and older) for treatment of osteoporosis and other bone loss conditions.Drug Safety Update article. Please continue to report suspected adverse drug reactions to the Yellow Card scheme. Healthcare professionals, patients, and caregivers are asked to submit reports using the Yellow Card scheme electronically using:Serious and life-threatening hypercalcaemia has been reported with denosumab 60mg (Prolia) in children and adolescents in clinical trials for osteogenesis imperfecta and during off-label use. The MHRA advises denosumab 60mg (Prolia) should not be used in children and adolescents younger than 18 years. For more information, please see the