WRITTEN QUESTION E-1975/03 by Anna Karamanou (PSE) to the Commission. Are commonly available antidepressants bad for the health?.
Date: 2003-06-13
Institutions: European Parliament, Provisional data
Subjects: European Medicines Agency, consumer information, consumer protection, drug surveillance, health risk, pharmacology, public health

26.2.2004

EN

Official Journal of the European Union

C 51 E/171

Under the national CARDS programme, a project endowed with EUR 2 million has been set up to help the
FYROM Government review its legislation on asylum and launch a national action programme on matters
of asylum, migration and visas, together with a training programme. EUR 1 million has been earmarked in
2003 to continue the 2002 programme. The European Agency for Reconstruction is studying the ways of
continuing the programme and of defining the content in more detail.

The Commission consequently endorses the Declaration of 3 June 2003 by the Union Heads of Mission in
Skopje, who stressed that they had given most serious consideration to the steps taken by the Kosovar
Roma in Medzitlija to improve their situation and strongly encouraged them to accept the offer made by
the FYROM Government to leave the border area and return to Skopje.

Moreover, the Commission is also continuing to support the efforts of the international community to put
in place appropriate conditions for the voluntary return to Kosovo of the persons displaced in 1999,
including those of Roma origin.

(2004/C 51 E/191)

WRITTEN QUESTION E-1975/03

by Anna Karamanou (PSE) to the Commission

(13 June 2003)

Subject: Are commonly available antidepressants bad for the health?

Following many reports of suicide and serious withdrawal symptoms in general among users of commonly
available antidepressants including Prozac, the British Government ordered an inquiry by its Committee on
Safety of Medicines. It appears that serious withdrawal symptoms are in fact very frequent with users often
needing months to overcome their dependency and that in certain cases this leads to suicide.

What steps will the Commission take with a view to elucidating fully this extremely serious matter? Will it
launch large-scale investigations at European level so as to establish the degree of dependency possibly
resulting from the long-term use of antidepressants?

Answer given by Mr Liikanen on behalf of the Commission

(1 August 2003)

The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA)
informed the
Commission that new data from clinical trials of paroxetine (Seroxat) in children and adolescents were
received at the end of May 2003. These new data have been reviewed by an Expert Working Group on
SSRIs (selective inhibitor of serotonin reuptake) and the Committee on Safety of Medicines (CSM) of the
United Kingdom. The data do not demonstrate efficacy in depressive illness in this age group and show an
increase in the risk of episodes of self-harm and potentially suicidal behaviour in the Seroxat group
compared to placebo. Various analyses suggest that the risk of these events is between 1,5 and 3,2 times
greater with Seroxat compared to placebo.

On the basis of these data, CSM has advised that Seroxat should not be used in children and adolescents
under the age of 18 years to treat depressive illness. Seroxat is not licensed for use in this population
under 18 but it is used in this age group outside its licensed indications where prescribers make a
judgement on their own responsibility that it is the right treatment for a particular patient.

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Official Journal of the European Union

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26.2.2004

This advice was communicated to health professionals via the Public Health Link 10 June 2003 and was
placed on the MHRA website, along with information for patients. Revised patient information leaflets
containing the new advice are being sent to prescribers and pharmacists.

This new safety signal in the paediatric population raises concerns about the balance of risks and benefits
of paroxetine. The United Kingdom considers that in the interests of the Community, the balance of risk
and benefits of paroxetine should be reassessed.

to the Committee for Proprietary Medicinal Products (CPMP) of the European Medicines
A referral
Evaluation Agency (EMEA) based on Article 31 of Directive 2001/83 EEC (1) was initiated by the United
Kingdom on 12 June 2003. This was discussed at the June 2003 meeting of the CPMP and the procedure
has been started.

The issue of withdrawal reactions and suicidal behaviour for Prozac (fluoxetine) was reviewed at European
level by the Committee on Proprietary Medicinal Products (CPMP) of the EMEA. This Committee reached
the following conclusions in September 2002:

Based on the information available and the discussion within the Committee, the CPMP considered
that the benefit/risk ratio of Prozac is favourable for the use relating to major depressive episodes,
obsessive-compulsive disorder and as a complement of psychotherapy in the treatment of bulimia
nervosa.

In the Summary of Product Characteristics the following information must be included:

4.4 Special warnings and special precautions for use

Suicide: As improvement may not occur during the first few weeks of treatment, in common with all
antidepressants, patients should be closely monitored during this period. The possibility of suicide
attempt is inherent in depression and may persist until significant remission occurs. It is general
clinical experience with all therapies for depression that the risk of suicide may increase in the early
stage of recovery.

4.8 Undesirable effects

When stopping treatment, withdrawal symptoms have been reported in association with SSIRs
(selective inhibitor of serotonin reuptake) although the available evidence does not suggest this is due
to dependence. Common symptoms include dizziness, paraethesia, headache, anxiety and nausea, the
majority of which are mild and self-limiting.

Plasma fluoxetine and norfluoxetine concentrations decrease gradually at the conclusion of therapy,
which makes dosage tapering unnecessary in most patients.

4.2 Posology and method of administration

In agreement with the consensus statement of the WHO (World Health Organisation), antidepressant
medication should be continued for at least 6 months.

Children: The use of fluoxetine in children and adolescents (under the age of 18) is not recommended,
as safety and efficacy have not been established.

The information is available on the EMEA website. (www.emea.eu.int)

The Pharmacovigilance Working Group of the Scientific Committee of the EMEA is monitoring closely all
medicinal products of the class of selective inhibitor of serotonin reuptake (SSRI), including fluoxetine.
Previously, in 2000, CPMP agreed core safety warnings for SSRIs in relation to withdrawal symptoms.

(1) Directive 2001/83/EC of the Parliament and of the Council of 6 November 2001 on the Community code relating

to medicinal products for human use, OJ L 311, 28.11.2001.