The Medicines and Healthcare products Regulatory Agency (MHRA) is “strengthening” dependency and addiction warnings for drugs commonly used to treat pain, anxiety and insomnia, it announced yesterday (January 8).
The regulator said following a “comprehensive safety review”, warnings 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”.
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The medicines will now carry the warning “may cause addiction, dependence and withdrawal reactions”, it added.
And patient information leaflets (PILs) 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”.
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The MHRA said that during the review, the Commission on Human Medicines (CHM) also “supported the development of new patient resources highlighting key safety messages”, such as “warnings not to use these medicines with opioids or alcohol, and not sharing medication with others”.
And it added that the CHM “recommended continued engagement with healthcare stakeholders to support professional training and the development of further resources”.
“Can happen to anyone”
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,” she added.
She said the drugs “remain valuable treatments for many patients and it’s important they have the information they need to be able to use them safely”.
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It comes after the MHRA announced in December that, following a “detailed review”, the wording in patient leaflets for antidepressant medicines will be “strengthened” to give “greater clarity on the risk of suicidal behaviour”.
The regulator said the review was launched “after concerns were raised by families and patients that current safety warnings” in the PILs for these drugs “did not clearly explain certain side effects”.
