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Prolia (denosumab 60mg) safety update

Hypercalcaemia in under-18s

May 20th 2022

Tagged: MHRA alert

By MHRA

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.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 Drug Safety Update articlePlease 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: