- What is
- Why did
the EMEA/CPMP review paroxetine?
- What were
these safety concerns?
evidence has CPMP reviewed?
- Is the
paroxetine review now finalised?
- What are
the recommendations of the CPMP/EMEA?
CPMP/EMEA banning the use of paroxetine in children and adolescents?
- What are
the withdrawal reactions occurring with paroxetine?
- What can
be done for withdrawal symptoms?
- My child
is already taking paroxetine. What should I do?
- What are
the concerns regarding paroxetine and suicidal thoughts or
- Is the
EMEA/CPMP also reviewing other SSRIs regarding safety?
- What is paroxetine?
Paroxetine is a selective Serotonin Re-uptake Inhibitor (an
SSRI) medicine. It affects the transmission of chemical messages in
the brain and nervous system. And is used to treat conditions such as
depression, obsessive compulsive disorder, panic disorder with
without agoraphobia, social anxiety disorder (social phobia),
generalised anxiety disorder and post-traumatic stress
- Why did the EMEA/CPMP review paroxetine?
The EMEA and CPMP have conducted a
review of the benefits and risks of paroxetine containing medicines
through a formal referral procedure. The referral was made by UK due
to safety concerns in relation to the use of these medicines. The
Community review started on 26 June 2003.
- What were these safety concerns?
Due to emerging data from clinical
trials there were concerns about an increased risk of suicidal
behaviour and hostility in children
and adolescents treated with
paroxetine. Concerns were also raised about the risk of withdrawal
reactions upon stopping paroxetine treatment in adults and children
and whether or not there was the possibility of an increased risk of
suicidal behaviour in the adult population.
- What evidence has CPMP reviewed?
In line with their legal obligations,
companies (Marketing Authorisation Holders) provided CPMP with all
scientific data relevant to the safety and efficacy of paroxetine
treatment including data from clinical trials, spontaneous adverse
reaction reports, epidemiological studies and published literature.
General background data on the medical conditions involved and
treatment options were also reviewed. The committee consulted
relevant experts including child psychiatrists.
CPMP to evaluate the benefits of treatment with paroxetine and to
balance these against the risks of side effects.
- Is the paroxetine review now finalised?
The EMEA’s scientific committee,
the CPMP, has given its formal Opinion and recommendations on 22 April
2004. In line with EU legislation the next step will be for the
European Commission to give its Decision.
- What are the recommendations of the
concluded that the benefit-risk remains positive for paroxetine
containing medicines in the treatment of adults but recommends changes
to the product information for paroxetine on a EU-wide basis. These
- A warning to reflect that paroxetine should not
be used in children and adolescents. In the EU paroxetine is not
use in this population. Data from clinical trials
raised concerns regarding suicidal behaviour and hostility. In
addition data from clinical trials have not adequately demonstrated
efficacy in these age groups.
- A warning to prescribers recommending close
monitoring of patients at high risk of suicidal behaviour. These
include patients with a known history of suicidal behaviour or
suicidal thoughts prior to starting treatment and possibly young
- Prescribers and patients should be warned
regarding the occurrence of withdrawal reactions upon stopping
Generally these are mild to moderate and
self-limiting, however in some patients they may be severe and/or
- Is CPMP/EMEA banning the use of paroxetine in children
not authorised to be used in these age groups. Should a child or
adolescent however be receiving paroxetine, the
treating doctor is
advised to exercise caution. Child psychiatrists can also consider the
use of alternative treatments such as cognitive behavioural therapy
for childhood depression.
- What are the withdrawal reactions occurring with
These symptoms may
occur upon stopping treatment with paroxetine. Typically they can
include dizziness, altered sensation (eg. numbness, “pins and
needles”, “electric shock sensations”), sleep problems including
intense dreams, , anxiety and headache.
Less common symptoms
include agitation, nausea, tremor (shaking of parts of the body, eg.
hands), confusion, sweating, diarrhoea, palpitations, emotional
instability, irritability or problems with vision (eyesight).
In some patients withdrawal symptoms may be severe in
nature or prolonged. Usually, however they are mild to moderate and
self-limiting and should resolve within 2 weeks of stopping
paroxetine. Patients treated with high doses, those treated for longer
duration and patients whose treatment is abruptly stopped may be at an
increased risk of withdrawal symptoms.
- What can be done for withdrawal symptoms?
When a doctor decides to stop
paroxetine the best approach is to gradually reduce the dose over
several weeks or months. The treating physician or psychiatrist is
best placed to determine how paroxetine is tapered and withdrawn
according to the needs of the individual patient. Paroxetine must
not be stopped suddenly, except on medical advice.
- My child is already taking paroxetine. What should I
If you are concerned or if
your child has experienced suicidal thoughts, it is vital that you
discuss this with your doctor who is familiar with your child’s
medical condition and the options for treatment. You should ensure
that your child does not suddenly stop taking paroxetine as withdrawal
symptoms can occur and may be severe in some patients. You should
contact your doctor, who is best placed to advise on further
management of your child.
- What are the concerns regarding paroxetine and suicidal
thoughts or behaviour?
Part of the CPMP/EMEA review of paroxetine concerned the
risk of suicidal thoughts and behaviour. This is a complex issue as
some conditions, that paroxetine is used to treat (e.g. depression)
are known to be associated with a risk of suicide. In addition, as
with other antidepressants, paroxetine may only start to work
effectively after some weeks of starting treatment. This means that
pre-disposed patients could be particularly vulnerable to suicidal
thoughts and behaviour in the early part of treatment.
Based on its review of available scientific data CPMP
recommends close monitoring of patients at high risk. These include
patients with a known history of suicidal behaviour or suicidal
thoughts prior to starting treatment and possibly young adults.
Should suicidal thoughts or behaviour arise during
paroxetine treatment, medical advice should be sought
- Is the EMEA/CPMP also reviewing other SSRIs regarding
At this time no
request by EU National Competent Authorities has been made for
CPMP/EMEA to review the SSRI class. Medicines in this class have
similarities in their pharmacological actions. There are also some
differences between them in term of how they are absorbed and handled
within the body.
The competent authorities are continuing to monitor the
safety of SSRIs in the same way as with other classes of medicines
authorised in the EU.
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