Selective Serotonin Reuptake Inhibitors (SSRI)

Current Problems in Pharmacovigilance: Volume 26

Selective serotonin reuptake inhibitors (SSRIs)

A review of the Yellow Card reports, published literature and current product information has identified adverse reactions which can be considered common to all SSRIs and these are listed.

Committee on Safety of Medicines (CSM)

Report of the CSM Expert Working Group on the safety of selective serotonin reuptake inhibitor antidepressants (2004)

A review of the evidence on aspects such as use in children, adolescents and young people, suicidal behaviour; withdrawal reactions and dosing.

Drug Safety Update Aug 2007

Antidepressants: suicidal behaviour

Young adults on antidepressant treatment should be monitored closely.

Drug Safety Update Apr 2008

Antidepressants: suicidal thoughts and behaviour - summary report

Summary of European and US Food and Drug Administration assessment of suicide risk.

Drug Safety Update Aug 2009

Monitoring the impact of regulatory action taken by the MHRA

Commissioned research programme:

The impact of regulatory action taken by the MHRA on SSRIs.

Drug Safety Update Mar 2010

Fluoxetine: possible small risk of congenital cardiac defects

Possible small increased risk of congenital cardiac defects in association with fluoxetine in early pregnancy, similar to that with paroxetine. There are insufficient data to draw conclusions on whether there is a similar risk for other SSRIs.

Drug Safety Update May 2010

SSRIs and SNRIs: risk of persistent pulmonary hypertension in the newborn

SSRIs in pregnancy, particularly in the later stages, may increase the risk of persistent pulmonary hypertension in the newborn.

Drug Safety Update May 2010

Antidepressants: risk of fractures

Small increased risk of fractures associated with TCAs and SSRIs

Drug Safety Update Nov 2010

Tamoxifen for breast cancer: drug interactions involving CYP2D6, genetic variants, and variability in clinical response

Concomitant use of medicines known to be potent CYP2D6 inhibitors should be avoided whenever possible in patients treated with tamoxifen. Such drugs include paroxetine, fluoxetine, bupropion, quinidine and cinacalcet.

Drug Safety Update Dec 2011

Citalopram and escitalopram: QT interval prolongation—new maximum daily dose restrictions (including in elderly patients), contraindications, and warnings

To reduce the risk of prolonging QT-interval, max. daily doses of citalopram and escitalopram restricted and lower max. doses apply to the elderly and patients with hepatic impairment.

Product-specific information and advice from the MHRA

Selective serotonin reuptake inhibitors and serotonin and noradrenaline reuptake inhibitors

Key areas of safety concerns with SSRI and SNRIs.