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
-
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.
-
The MHRA is an executive agency of the Department of Health
and Social Care.
-
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.
-
Full details of the review findings are available in
the Drug Safety
Update and Public Assessment
Report.
-
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.
