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

Drug Safety Update - April 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for April 2022 (PDF).

This issue advises that a recent study has indicated that pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. Data from 2,700 pregnancies with pregabalin exposure in the first trimester was compared with exposure to no antiepileptic drugs or lamotrigine or duloxetine. Full details of the study have been published. Patients are advised to continue to use effective contraception during treatment and avoid use in pregnancy unless clearly necessary.

This issue contains the latest COVID-19 vaccine and medicine information including reassuring real-world data for for Spikevax COVID-19 vaccine and Comirnaty COVID-19 vaccine when used during pregnancy and breastfeeding. This section also notifies readers of the approval of Valneva COVID-19 vaccine and Evusheld (tixagevimab/cilgavimab) for COVID-19 prevention.

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