The addiction, dependency and withdrawal warnings will be added to packaging and patient information leaflets for gabapentinoids, benzodiazepines and z-drugs.
Dr Alison Cave, MHRA chief safety officer, said: ‘Addiction and dependency can happen to anyone taking these medicines, even when used as directed. That's why we are strengthening warnings so patients and healthcare professionals can better understand the risks.
‘These medicines remain valuable treatments for many patients and it's important they have the information they need to be able to use them safely.'
The MHRA said it will continue to monitor the safety of gabapentinoids, benzodiazepines and z-drugs and will take further regulatory action if appropriate.
The changes to product information will be implemented by manufacturers over a transition period. Healthcare professionals and patients can find more information and resources in the Drug Safety Update.
The review followed the MHRA's previous work on opioid medications in 2019 and is part of a wider programme examining dependency-forming medicines in response to a Public Health England report from September 2019.
