On 18th May 04, the Health Sciences Authority (HSA) highlighted the emerging concerns raised internationally on the increased risk of suicidal ideation in patients under 18 years of age who are taking selective serotonin reuptake inhibitors (SSRIs) and related antidepressants for major depressive disorder (MDD).
Following the recommendations of its advisory committees, the US Food and Drug Administration (FDA) announced on 15th Oct 04 that it would require manufacturers of all antidepressants to strengthen the label warnings to warn prescribers of an increased risk of suicidality (suicidal thinking and behaviour) in children and adolescents. In consultation with HSA's Pharmacovigilance Advisory Committee and experts in the field of psychiatry, HSA has reviewed this development in the US and would like to provide the following update.
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Findings of the US FDA's review
The risk of suicidality for the antidepressants was identified in a combined analysis of short-term (up to 4 months) placebo-controlled trials of nine antidepressants, which included the SSRIs, in children and adolescents with MDD. The US FDA reviewed a total of 24 trials involving 4,400 patients. The analysis showed a greater risk of suicidality during the first few months of treatment in those receiving antidepressants. The average risk of such events was 4% for patients on antidepressants compared to 2% for those on placebo. No suicides occurred in these trials.
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Conclusion on risk/benefit of antidepressants
There is an increased risk of suicidal ideation and behaviour in children and adolescents who are prescribed SSRIs and related antidepressants for MDD. This increased risk generally outweighs the possible benefits. Since the available data cannot exclude increased risk of these effects when any single medication in these groups is consumed by patients under 18 years of age, HSA has adopted US FDA's stand to apply this increased risk to all antidepressants.
In the case of adult patients with MDD, the risk/benefit ratio of the use of antidepressants, in general, remains favourable. Although there is some evidence that there may be an increased risk of suicide ideation in patients taking SSRIs, the overall proven efficacy of antidepressants in adult patients outweighs the possible risks.
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Advisory
It is also important to note that children and adolescents who are currently treated for MDD with antidepressants should not have their medications discontinued abruptly as there may be withdrawal symptoms associated with abrupt discontinuation.
HSA will be following up with the relevant pharmaceutical companies to determine appropriate changes to the labeling or packaging of affected products.
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