The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for May 2022 (PDF).
This issue advises clinicians that denosumab 60mg (Prolia®) should not be used in patients under 18 years due to the risk of serious hypercalcaemia. Cases of serious and life-threatening hypercalcaemia has been reported with denosumab 60mg in children and adolescents in clinical trials for osteogenesis imperfecta and during off-label use. Patients already on this treatment who are younger than 18 years, and their parents or caregivers, are encouraged talk to their specialist about what this means for them.
This issue contains the latest COVID-19 vaccine and medicine information including notification that the 15-minute observation period following vaccination with COVID-19 Vaccine Pfizer/BioNTech or Moderna has been removed for individuals aged 12 years and over who have no history of a severe allergic reaction.
Lastly in this issue is a summary of letters to healthcare professionals in April. These generally related to supply issues and recalls.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.