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 |