An Expert Working Group (EWG) of the Commission on
Human Medicines (CHM), advising the Medicines and Healthcare
Products Regulatory Agency (MHRA), has
concluded a detailed review into how
the potential risks associated with 28 antidepressant
medicines are communicated to patients within the
Patient Information Leaflet (PIL).
The review was launched after concerns were
raised by families and patients that current safety
warnings in the PILs for these medicines did
not clearly explain certain side effects
– specifically suicidal behaviours, and
sexual dysfunction that may continue after the treatment is
stopped.
Over the past 18 months, the EWG has heard directly from
families, patients, and mental health support organisations. The
group considered the real-world experiences of those
affected, together with the scientific literature, to
understand how warnings could be made clearer and
more easily understood by patients.
Based on the group's recommendations, the CHM has
advised that the wording in the PILs provided with
antidepressant medications should be strengthened to provide
greater clarity on the risk of suicidal behaviour. The revised
text will be further developed through user testing to
ensure it is as clear and effective as
possible, and the MHRA is exploring a range of engagement
options to take this advice forward.
The CHM has also recommended updates to the PILs for certain
antidepressants to better reflect patient feedback and emerging
evidence on the potential for sexual dysfunction that
may continue after stopping treatment.
Several additional communication measures have been
agreed, including:
-
the introduction of a patient card to be given to
patients by their healthcare professional or included in
the medicine pack and available digitally to
further highlight the risk of suicidal
behaviour;
-
an ancillary leaflet to support discussions between patients
and healthcare professionals regarding the risk of
suicidal behaviour developed with wider healthcare
system partners
The MHRA is engaging with the National
Institute for Health and Care Excellence (NICE), the British
National Formulary (BNF), and the Royal Colleges of General
Practice and Psychiatrists to improve consistency of safety
messaging in a range
of additional communications.
The MHRA recognises that many families and patients are waiting
to see the final products that have been developed as a
result of the review. While regulatory
processes are ongoing there are limitations in the
level of detail the MHRA is able to communicate. As soon
as the regulatory position is finalised, the MHRA is
committed to communicating on the final products as
quickly as possible.
Patients should continue taking their medicines as prescribed and
not stop or change treatment without first speaking to a doctor
or mental health professional. Please also read the PIL
which contains important information about your
medicine. Anyone experiencing side effects should seek
medical advice and report suspected side effects via
the Yellow Card
scheme.
Notes to Editors:
-
Antidepressants, including selective serotonin reuptake
inhibitors (SSRIs), are widely used for the treatment of
depression and other mental health conditions. The MHRA
rigorously monitors the safety of these medicines,
including side effects and emerging evidence.
-
As well as having beneficial effects, antidepressants can
cause side effects in some people, and in some cases these
can be severe. Details of possible side effects are
provided in the Patient Information Leaflets (PILs)
accompanying these medicines.
-
All known side effects associated with individual
antidepressants are outlined in the Summary of Product
Characteristics (SmPC) for healthcare professionals and
reflected in lay language in the PILs
which can be found in the medicine packs.
-
If you're having suicidal thoughts, help is
available now. You can call NHS 111 (24 hours every day),
Samaritans on 116 123, or text “SHOUT” to 85258. Find more
information and support options on the NHS
website.
-
The Commission on Human
Medicines (CHM) is an independent statutory body,
whose members are appointed directly by ministers. Members
are not employees of the Agency and are appointed to advise
government (Health Ministers), through the licensing
authority (the Medicines and Healthcare products Regulatory
Agency (MHRA)).
-
The Antidepressant Risk
Minimisation Expert Working Group was set
up to advise the CHM on any
recommendations for additional risk minimisation
measures on the risk of suicidal behaviour associated with
all antidepressants and sexual dysfunction which
may continue on stopping
treatment.
