Key Summary
- Stronger safety warnings to be added to gabapentinoids, benzodiazepines and Z-drugs
- Clearer guidance on safer use, tapering, and talking with healthcare professionals
- Extra cautions against mixing with opioids/alcohol and sharing medicines; changes rolling out soon
The warnings on the packaging and patient information leaflets for gabapentinoids, benzodiazepines, and z-drugs are being strengthened to inform patients and healthcare professionals of the risks of dependency, addiction, withdrawal, and tolerance.
The move follows a safety review by the Medicines and Healthcare products Regulatory Agency (MHRA) of these medicines.
They are commonly prescribed to treat a range of conditions including neuropathic pain, anxiety and insomnia.
These medicines will now carry the warning ‘May cause addiction, dependence, and withdrawal reactions’, and the patient information leaflets will include clearer definitions of dependence and addiction, improved guidance on how to safely taper and stop its usage.
It will also provide information to encourage conversations between patients and healthcare professionals during their treatment.
During the review, the Commission on Human Medicines (CHM) found it was necessary to strengthen warnings of the known risks associated with these medicines.
The CHM has also supported the development of new patient resources highlighting key safety messages, including warnings not to use these medicines with opioids or alcohol, and not sharing medication with others.
These changes will be implemented by manufacturers over a transition period.
MHRA chief safety officer Dr Alison Cave 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.
“If you have any questions regarding medication use or side effects, please speak to a healthcare professional. Do not stop taking your medicine without advice, as this could cause withdrawal symptoms.”
