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\u00a0better\u00a0inform\u00a0patients and healthcare professionals of the\u00a0risks of dependency, addiction, withdrawal,\u00a0and tolerance.\u00a0\u00a0<\/p>\n
These\u00a0medicines, which\u00a0are\u00a0commonly prescribed to treat\u00a0a range of conditions including neuropathic pain, anxiety and insomnia, will now carry the warning \u2018May cause addiction, dependence, and withdrawal reactions\u2019. 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.\u00a0<\/p>\n
As part of the review, the\u00a0Commission on Human Medicines (CHM)\u00a0found\u00a0it was necessary to strengthen warnings\u00a0of the known risks\u00a0associated with these medicines.\u00a0In addition to changes to\u00a0packaging\u00a0and product information, the CHM supported the development of\u00a0new\u00a0patient resources\u00a0highlighting\u00a0key safety messages,\u00a0including warnings\u00a0not\u00a0to use\u00a0these medicines with opioids or alcohol, and not sharing medication with others.\u00a0\u00a0<\/p>\n
The CHM also\u00a0recommended\u00a0continued engagement with healthcare stakeholders to support professional training and the development of further resources.<\/p>\n
Dr Alison Cave, MHRA Chief Safety Officer, said:\u00a0<\/p>\n
\u201cAddiction and dependency can happen to anyone taking these medicines, even when used as directed.\u00a0That\u2019s\u00a0why we are strengthening warnings so patients and healthcare professionals can better understand the risks.\u00a0<\/p>\n
\u201cThese medicines remain valuable treatments for many patients and\u00a0it\u2019s important they have the\u00a0information they need to\u00a0be able to\u00a0use them safely.\u00a0<\/p>\n
\u201cIf you\u00a0have any questions\u00a0about your\u00a0medication\u00a0use or side effects, please speak to a healthcare professional. Do not stop taking your medicine without advice, as this could cause withdrawal symptoms.\u201d\u00a0<\/p>\n
The MHRA will continue to\u00a0monitor\u00a0the safety of\u00a0gabapentinoids, benzodiazepines and z-drugs and will take further regulatory action if this is\u00a0appropriate.\u00a0<\/p>\n
The changes to product information will be implemented by manufacturers over a transition period.\u00a0Healthcare professionals and patients can find more information\u00a0and resources\u00a0in the\u00a0Drug Safety Update<\/a>.<\/p>\n This review follows\u00a0the\u00a0MHRA\u2019s\u00a0previous\u00a0work on opioid medications in 2019<\/a>\u00a0and is part of a wider programme examining dependency-forming medicines in response to\u00a0a Public Health England report from September 2019.<\/a>\u00a0<\/p>\n Anyone who suspects that they are experiencing a side effect from\u00a0these medicines\u00a0is\u202fadvised to speak\u202fto a healthcare professional and report it directly to the\u202fMHRA Yellow Card scheme<\/a>.<\/p>\n Notes to editors\u202f\u00a0<\/p>\n The Medicines and Healthcare products Regulatory Agency (MHRA) is the regulator of medicines, medical devices,\u00a0and blood components for transfusion in the UK. The MHRA\u00a0is responsible for\u00a0making sure these products meet acceptable standards for safety,\u00a0quality,\u00a0and efficacy.\u00a0<\/p>\n The MHRA is an executive agency of the Department of Health and Social Care.\u202f\u202f\u202f\u202f\u202f\u00a0<\/p>\n The Commission on Human Medicines (CHM) advises ministers on the safety,\u202fefficacy,\u202fand quality of medicinal products.\u00a0It\u00a0is independent and is not part of the government or the pharmaceutical industry.\u00a0\u00a0<\/p>\n Full details of the review findings are available in the\u00a0Drug Safety Update<\/a>\u00a0and\u00a0Public Assessment Report<\/a>.<\/p>\n 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<\/a> or by searching the Google Play or Apple App stores for MHRA Yellow Card.\u202f\u202f\u00a0<\/p>\n