Drug Safety Update May 2022: advice on denosumab

MHRA Drug Safety Update

May 2022

Denosumab 60mg (Prolia): should not be used in patients under 18 years due to the risk of serious hypercalcaemia

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. Denosumab 60mg (Prolia) is authorised for use in adults with osteoporosis and other bone loss conditions – it should not be used in children and adolescents younger than 18 years.

COVID-19 vaccines and medicines: updates for May 2022

Recent information relating to COVID-19 vaccines and medicines that has been published since the April 2022 issue of Drug Safety Update, up to 13 May 2022.

Letters and medicine recalls sent to healthcare professionals in April 2022

A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices. Includes a recent recall of Accupro (quinapril hydrochloride) and advice on Xagrid (anagrelide hydrochloride).

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Drug Safety Update is a monthly newsletter from the Medicines and Healthcare products Regulatory Agency (MHRA) and its independent advisor the Commission on Human Medicines.

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