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news.The EMEA has completed its review of two classes of antidepressants and concluded that they should not be used in children and adolescents except in their approved indications. An Agency committee has recommended that the drugs carry strong warnings about suicidality and hostility risks.
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The review of serotonin-selective reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) medicines looked at the potential risk of suicidal behavior in children and adolescents treated with these products.
The Agency’s scientific committee, the Committee for Medicinal Products for Human Use (CHMP), concluded at its 19-22 April 2005 meeting that suicide-related behavior (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behavior and anger) were more frequently observed in clinical trials among children and adolescents treated with these antidepressants compared to those treated with placebo.
The Agency’s committee is therefore recommending the inclusion of strong warnings across the whole of the European Union to doctors and parents about these risks. Doctors and parents will also be advised that these products should not be used in children and adolescents except in their approved indications.
The review looked at the medicines containing the following substances: atomoxatine, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacepran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine.
Based on the data reviewed, the CHMP concluded that a warning reflecting the increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility should be included in the product information of citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine containing medicinal products.
For atomoxetine (marketed by Eli Lilly as Strattera), although no signal of suicide related behavior was seen in studies, the Committee concluded that a warning reflecting the increased risk of side-effects such as hostility and emotional lability and a warning indicating the lack of efficacy in depression should be included in the product information.
Most of these products are approved for the treatment of depression and anxiety in adults in the European Union, but are not licensed Europe-wide for the treatment of these conditions in children or adolescents. Some of these products are, however, licensed for paediatric use for the treatment of obsessive-compulsive disorder and one of them (atomoxetine) for the treatment of ADHD.