Regulatory Updates

The MHRA released a summary of letters and notifications regarding medicines and medical devices sent to healthcare professionals in October 2024.

The MHRA has released a summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.

The MHRA released a summary of letters and notifications sent to healthcare professionals about medicines and medical devices in December 2024.

Healthcare professionals warned of pulmonary aspiration risk in patients on GLP-1 or dual GIP/GLP-1 agonists undergoing general anaesthesia or deep sedation.

The Commission on Human Medicines says men already taking valproate no longer need a specialist review, while the requirement stays for patients under 55 starting the drug.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) released a summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.

The MHRA has withdrawn the licence indication for post‑operative pain from all prolonged‑release opioids, citing heightened risk of persistent use and opioid‑induced respiratory complications.

MHRA warns that fezolinetant can cause drug‑induced liver injury and advises liver function monitoring before and during treatment.

The MHRA reminds healthcare professionals and patients that overusing short‑acting β2‑agonists can trigger severe asthma attacks and increase mortality, even with maintenance therapy.

MHRA notes rare reports of anxiety, low mood, sleep disturbance, poor concentration and forgetfulness in CF patients using Kaftrio, urging clinicians to monitor patients.

The MHRA notes rare cases of intrahepatic cholestasis of pregnancy in patients using azathioprine and other thiopurines, highlighting a class‑wide risk.

The UK MHRA reports a slight rise in Guillain‑Barré syndrome cases after administration of Pfizer’s Abrysvo and GSK’s Arexvy RSV vaccines in adults aged 60 and older.