Following a comprehensive safety review by the Medicines and Healthcare products Regulatory Agency (MHRA), warnings on the packaging and patient information leaflets for gabapentinoids, benzodiazepines, and z-drugs are being strengthened to better inform patients and healthcare professionals of the risks of dependency, addiction, withdrawal, and tolerance.
These medicines, which are commonly prescribed to treat a range of conditions including neuropathic pain, anxiety and insomnia, will now carry the warning ‘May cause addiction, dependence, and withdrawal reactions’. Patient information leaflets will include clearer definitions of dependence and addiction, improved guidance on how to safely taper and stop use, and information to encourage conversations between patients and healthcare professionals during their treatment.
As part of the review, the Commission on Human Medicines (CHM) found it was necessary to strengthen warnings of the known risks associated with these medicines. In addition to changes to packaging and product information, the CHM 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.
The CHM also recommended continued engagement with healthcare stakeholders to support professional training and the development of further resources.
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 MHRA will continue to monitor the safety of gabapentinoids, benzodiazepines and z-drugs and will take further regulatory action if this is 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.
This review follows 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.
Anyone who suspects that they are experiencing a side effect from these medicines is?advised to speak?to a healthcare professional and report it directly to the?MHRA Yellow Card scheme.
Notes to editors?
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The Medicines and Healthcare products Regulatory Agency (MHRA) is the regulator of medicines, medical devices, and blood components for transfusion in the UK. The MHRA is responsible for making sure these products meet acceptable standards for safety, quality, and efficacy.
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The MHRA is an executive agency of the Department of Health and Social Care.?????
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The Commission on Human Medicines (CHM) advises ministers on the safety,?efficacy,?and quality of medicinal products. It is independent and is not part of the government or the pharmaceutical industry.
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Full details of the review findings are available in the Drug Safety Update and Public Assessment Report.
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Suspected side effects or adverse drug reactions to any medicines should be reported to the MHRA Yellow Card scheme, either through the Yellow Card website or by searching the Google Play or Apple App stores for MHRA Yellow Card.??
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For media enquiries, please contact newscentre@mhra.gov.uk, or call on 020 3080 7651.