Class 4 Medicines Defect Notification: Special Concept Development UK Limited, Baclofen 10mg Tablets, EL(25)A/51

Guidance for manufacturers of cardiac implantable electronic devices and their leads. It outlines specific scenarios that should be considered when determining if an incident is reportable.

Officers from the MHRA’s Criminal Enforcement Unit (CEU) have raided two separate premises as part of an ongoing investigation into an organised criminal network involved in the manufacture and sale of unlicensed weight loss medicines. 

There is a small increase in the risk of Guillain-Barré syndrome following vaccination with Abrysvo (Pfizer respiratory syncytial virus (RSV) vaccine) and Arexvy (GSK RSV vaccine) in adults aged 60 years and older. Healthcare professionals should advise all recipients of Abrysvo and Arexvy that they should be alert to signs and symptoms of Guillain-Barré syndrome and, if they occur, to seek immediate medical attention as it requires urgent treatment in hospital.

As with any medicine, the MHRA will keep the safety and effectiveness of Nirogacestat hydrobromide under close review.

Opella Healthcare UK LTD has informed the MHRA that there is an error on the artwork for the outer carton of Dulcolax Adult 5mg GR Tablets (packsize 20 count). The dose instruction incorrectly states for use in 12 years and older. These general sale packs are intended for use only in adult patients (18 years and over).

As the cold weather sets in and coughs and colds become more common, the MHRA is reminding people that small, everyday choices can make a big difference to winter wellbeing.