The Medicines and Healthcare products Regulatory Agency has announced strengthened safety warnings for gabapentinoids, benzodiazepines and z-drugs, following a comprehensive review by the Commission on Human Medicines.
These medicines, commonly prescribed for neuropathic pain, anxiety and insomnia, will now carry clearer warnings about the risks of addiction, dependence, withdrawal and tolerance.
From now on, packaging for these medicines will include the warning: “May cause addiction, dependence, and withdrawal reactions.”
Patient information leaflets will also be updated to:
- Provide clear definitions of dependence and addiction.
- Offer improved guidance on safe tapering and stopping use.
- Encourage open conversations between patients and healthcare professionals during treatment.
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.
“If you have any questions about your 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.”
The CHM review concluded that stronger warnings were necessary to protect patients. Alongside packaging changes, new patient resources will highlight key safety messages, including:
- Do not use these medicines with opioids or alcohol.
- Do not share medication with others.
The CHM also recommended ongoing engagement with healthcare stakeholders to support professional training and the development of further resources.
The MHRA will continue to monitor the safety of gabapentinoids, benzodiazepines and z-drugs and take further regulatory action if needed.
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