Click to go to the MHRA website Back to MHRA website

CSM logo

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:


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:

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 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


MHRA home - MHRA home - CSM Home - Activities - Working Arrangements - Membership - Subcommittees - Yellow Card Scheme - CSM/MHRA Expert Advisory Panel - Summary Minutes - Declaration of Interests - Important Safety Messages - Current Problems in Pharmacovigilance - New Drugs Under Intensive Surveillance - HIV ADR Reporting Scheme - CSM Contacts