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Committee on Safety of Medicines

"Welcome to the Committee on Safety of Medicines (CSM) web pages. These provide information
about the Committee's responsibilities for advising the UK Licensing Authority to ensure that
medicines meet the standards of quality, efficacy and safety the public and health professions
would expect."

Latest news
10 December 2003
Use of Selective Serotonin Reuptake Inhibitors (SSRIs) in children and adolescents with
major depressive disorder (MDD) - only fluoxetine (Prozac) shown to have a favourable
balance of risks and benefits for the treatment of MDD in the under 18s
On the basis of a review of the safety and efficacy of the SSRI class in the treatment of paediatric
major depressive disorder undertaken by the Expert Working Group of the Committee on Safety
of Medicines (CSM), the CSM has advised that the balance of risks and benefits for the treatment
of major depressive disorder (MDD) in under 18s is judged to be unfavourable for sertraline,
citalopram and escitalopram and unassessable for fluvoxamine. Only fluoxetine (Prozac) has
been shown in clinical trials to have a favourable balance of risks and benefits for the treatment of
MDD in the under 18s. The following documents are available:
Message sent to health professionals including a leaflet for patients
A question and answer document
Overview of regulatory status and CSM advice relating to major depressive disorder (MDD)
in children and adolescents including a summary of available safety and efficacy data

3 December 2003
Use of hormone replacement therapy in the prevention of osteoporosis: important new
information
Hormone replacement therapy (HRT) is no longer recommended as first choice of therapy for
prevention of osteoporosis.This follows a European-wide review of the balance of risks and
benefits of HRT in response to growing concerns about the safety of HRT in long-term use. The
following documents are available:
Message sent to health professionals.
Products affected by this new advice.
Information sheet for patients.
Press statement.
Latest safety update on HRT for patients.
1 December 2003
Change in dose of emergency contraceptive (Levonelle)
In response to new data from a World Health Organisation (WHO) study, the Committee on Safety

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Committee on Safety of Medicines Home Page

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http://www.antidepressantsfacts.com/2003-12-10-CSM-SSRIs-childre...

of Medicines has advised that the dose should change from two tablets taken 12 hours apart to a
single dose of two tablets taken together. The MHRA press statement is attached here.

Crown copyright 2003

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