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

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

Year, Month	Country	Agency	Action
2003, May	-	GlaxoSmithKline	Reported to FDA increased suicidal behaviour associated with paroxetine
2003, June	U.K.	MHRA^a	Paroxetine contraindicated in <18 s
2003, September	U.K.	MHRA	Venflaxine contraindicated in <18 s
2003, October	U.S.	FDA^b	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	IMB^c	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	EMEA^d	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

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

ISSN: 1471-2431