- Prescribing Advice for GPs - https://www.prescriber.org.uk -

Drug Safety Update - October 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2021 (PDF).

This issue advises clinicians of a new restriction on the paediatric indication for chloral hydrate and cloral betaine. The treatments should only be used for the short-term treatment (maximum 2 weeks) of severe insomnia only when the child or adolescent has a suspected or definite neurodevelopmental disorder and when the insomnia is interfering with normal daily life. It is also recommended that these treatments are only used when other therapies (behavioural and pharmacological) have failed.

This issue also raises awareness of the sixth annual #MedSafetyWeek social media campaign. This year the focus is on he importance of reporting suspected adverse reactions to vaccines. Readers are encouraged to share MHRA materials on social media, as well as discussing with colleagues and patients how report adverse reactions to vaccines.

This issue also advises readers of the latest COVID-19 vaccine safety information including regulatory updates on the COVID-19 booster vaccine programme, updates to the Summary of Product Characteristics and Patient Information Leaflet for Janssen Vaccine and extension of the shelf life of the Pfizer/BioNTech Vaccine to 9 months

Lastly in this issue is a summary of letters to healthcare professionals in September.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.