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Table 1 Summary of the history of SSRI warnings across countries and agencies

From: Antidepressant prescribing in Irish children: secular trends and international comparison in the context of a safety warning

Year, Month

Country

Agency

Action

2003, May

-

GlaxoSmithKline

Reported to FDA increased suicidal behaviour associated with paroxetine

2003, June

U.K.

MHRAa

Paroxetine contraindicated in <18 s

2003, September

U.K.

MHRA

Venflaxine contraindicated in <18 s

2003, October

U.S.

FDAb

Advice paper published stating preliminary data suggests increased suicidal behaviour associated with SSRIs

2003, December

U.K.

MHRA

Contraindicate all SSRIs in <18 s apart from Prozac (fluoxetine)

2003, December

Ireland

IMBc

Endorses MHRA warning for Ireland

2004, February

U.S.

FDA

Commissioned advisory committee

2004, October

U.S.

FDA

Issued black box warning relating to all anti-depressants <18 s

2005, August

Europe

EMEAd

Issued warning against SSRIs in <18 s

2005, November

Ireland

IMB

Reissued warning and updated label guidelines

2007, May

U.S.

FDA

Increased age of risk of SSRIs to 24 years

2008, September

Ireland

IMB

Warnings adapted up to age 25

  1. aMedicines & Health Regulatory Agency bFood & Drug Administration c Irish Medicines Board dEuropean Medicines Agency