ADVERSE EVENTS ASSOCIATED WITH THE USE OF SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRI'S) ANTIDEPRESSANT MEDICATIONS AMONG CHILDREN- A REVIEW OF THE FDA ADVERSE EVENT REPORTING SYSTEM (AERS)
Author(s)
Chen HUniversity of Houston, Houston, TX, USA
OBJECTIVES: To examine the adverse events in children treated with SSRIs reported through the FDA’s Adverse Event Reporting System in response to the increased risks of suicide among children being treated with antidepressants. METHODS: A retrospective pharmacovigilance analysis was conducted using the January 2004 to September 2006 FDA Adverse Event Reporting System (AERS) data. The adverse drug event cases (ADEs) associated with SSRI antidepressants were identified based on the role of the medication in the incidence of the ADEs as the Primary and Secondary suspect. Children were defined as patients below 18 years. RESULTS: Out of 68,936 ADE cases involving SSRI antidepressants, the SSRIs were identified as the primary suspect in 27,075 cases and as the secondary suspect in 6,713 cases. Of those cases, there were merely 1,780 (5.26%) cases involving children. The number of cases reported to the FDA per quarter was 161.81 on an average for the 11 quarters data. Paroxetine accounted for the majority of the reported ADE, 778 (43.70%) cases involving children followed by Sertraline 315 (17.69%) and Escitalopram 273 (15.33%). Despite the low reporting rate, adverse events associated with SSRI antidepressants can have serious consequences. Suicide attempt was reported in 579 cases (16.88%) followed by psychotic disorders in 420 cases (12.24%). More than one third (608, 38.23%) of those cases led to hospitalization. CONCLUSIONS: Despite that the adverse events reported for SSRI antidepressants being taken by children were low; the consequences of those adverse events can be very serious. Suicide attempt was the most commonly reported adverse event. Paroxetine was the most common SSRI to be reported for adverse events and the main outcome was hospitalization.
Conference/Value in Health Info
2009-10, ISPOR Europe 2009, Paris, France
Value in Health, Vol. 12, No. 7 (October 2009)
Code
PIH2
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Pediatrics