EMEA completes review of SSRIs and recommends wider product warning
Selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors should not be used in children and adolescents except for their approved indications, the European Medicines Agency (EMEA) has concluded following its review of the antidepressants.
The review was initiated at the request of the European Commission in
December 2004 after safety warnings were issued about the potential risk
of suicidal behaviour in children and adolescents treated with these
products.
The recommendations, issued earlier this week, are generally in line
with those given by the Medicines and Healthcare products Regulatory
Agency in 2003 (PJ, 13 December 2003, p803), although do not single out
fluoxetine as the medicine most suitable for use among children and adolescents.
The EMEA concludes that a warning reflecting the increased risk of side
effects such as suicide attempt, suicidal thoughts and hostility in young
people should be included in the product information of citalopram, duloxetine,
escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine,
paroxetine, reboxetine, sertraline and venlafaxine.
The EMEA says that where a decision is made to use these products off-licence
for the treatment of depression or anxiety in children and adolescents,
the patient should be monitored carefully for the appearance of suicidal
behaviour, self-harm or hostility, particularly at the beginning of treatment.
The EMEA recommendations can be accessed at www.emea.eu.int
Xigris The EMEA has also recommended changes
in the way that drotrecogin alfa activated (Xigris) is used. It suggests
that the drug, used in patients with severe sepsis and multiple organ
failure, should only be used in high-risk patients, and mainly when
therapy can be started within 24 hours of the onset of organ failure.
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