List of Field Safety Notices from 23 to 27 June 2025.
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Field Safety Notices: 16-20 February 2026
List of Field Safety Notices: 16-20 February 2026
Improving Information Supplied with Gabapentinoids (Pregabalin/Gabapentin), Benzodiazepines and Z-Drugs
The MHRA has reviewed the warnings regarding addiction, dependence, withdrawal, and
tolerance for gabapentin, pregabalin, benzodiazepines, and z-drugs. The findings (detailed in the Public Assessment Report) were that it was necessary to strengthen these warnings in the product information and on packaging to better inform healthcare professionals and patients of these known risks.Isotretinoin: an expert review of suspected psychiatric and sexual side effects
The review of the safety of isotretinoin has concluded.
Aurum pre-filled syringes phased introduction of new 10ml CONNECT syringe barrel: Importance of selecting compatible needle-free connectors to minimise the risk of syringe blockage (DSI/2025/02)
Due to a phased introduction of the new 10ml CONNECT barrel design for the Aurum pre-filled syringes, the range of compatible needle free connectors (NFCs) differs between the established syringe barrel and the new syringe barrel. It is vital that healthcare professionals use compatible NFCs with Aurum pre-filled syringes to prevent delays to delivery of emergency medication.
Guidance: The Innovative Devices Access Pathway (IDAP)
The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.
Standard: Statement of Policy Intent: Early Access to Innovative Medical Devices
The MHRA’s initial plans on an Early Access service, which will be developed further throughout 2025.