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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