People who take prescribed or over-the-counter medicines
containing opioids for non-cancer pain will now be given
stronger warnings about the risk of dependence and
addiction, the Medicines and Healthcare products Regulatory
Agency (MHRA) announced today.
Healthcare professionals have been asked by the MHRA to
discuss these warnings with any patient taking or planning
to take an opioid-containing medicine. These discussions
should also involve agreement of a treatment plan,
including how long treatment should last, to minimize the
risk of dependence.
Additional warnings are now to be added to the patient
information leaflet to reinforce those warnings, making it
clear that the medicine is an opioid, which can cause
addiction, and that there can be withdrawal symptoms if
people stop taking it suddenly. More information and
warnings are provided throughout the leaflet.
Minister for Innovation said:
Opioid addiction is a serious and life-threatening issue
and people need to be aware of these risks before they
take medicines with such a high rate of dependency.
It is vital that patients are given the right support and
guidance on the dangers of long term use and the
strengthening of these labels is a crucial step forwards
in protecting patients and saving lives.
The MHRA Director of Vigilance and Risk Management of
Medicines, Sarah Branch said:
Patient safety is our highest priority and that is why we
continually monitor the benefits and risks of opioid
medicines.
Last year, we announced that opioid-containing medicine
packaging must carry warnings. Now, we are strengthening
those warnings to ensure that opioid medicines are
supplied with consistent information on how to manage the
risk of addiction.
This is a further step forward in helping to promote the
safe use of these pain-relieving medicines.
Opioids have a serious risk of dependence and addiction,
especially with long-term use. Following concerns raised
about the prescribing rates of opioids in the UK, the
Opioid Expert Working Group (EWG) of the Commission on
Human Medicines (CHM) developed a set of recommendations to
improve information for prescribers and patients and to
protect public health. These recommendations were fully
supported by CHM and formed the basis of the MHRA’s new
warnings.
While the CHM continues to consider opioids as important
and effective medicines in the treatment of short-term pain
relief, they have advised against their long-term use in
the treatment of non-cancer pain, due to the risk of
dependence and addiction.
For more information on the risks of opioid addiction,
please read our patient
guidance.
Patients experiencing any suspected side effects from these
medicines can report these via our Yellow Card
scheme.
