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

Drug Safety Update - February 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2024 (PDF).

This issue notifies clinicians that codeine linctus has now been reclassified as a prescription-only medicine (POM), following a public consultation. A recent review identified greater levels of recreational use than the intended use as a cough suppressant. As a risk minimisation measure to protect the health of patients this product will no longer be supplied without a prescription.

This issue also advises clinicians that pseudoephedrine has been very rarely associated with posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These conditions present with a sudden severe headache or thunderclap headache, sudden onset of nausea and vomiting, confusion, seizures and/or visual disturbances. Urgent medical attention should be sought if these symptoms occur and patients presenting with these symptoms should be asked about their medication history.

Lastly in this issue is a summary of letters to healthcare professionals in January. These generally related to supply issues and recalls but also include letters sent to appropriate healthcare professionals about revised educational materials for valproate-containing medicines, the dose-dependent increased risk of atrial fibrillation in patients using omega-3-acid ethyl ester medicines as reported in the drug safety update last month and a change to the pump priming advice prior to first use of Tostran® (Testosterone, 2% gel) following a manufacturing change.

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