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Selective Serotonin Reuptake Inhibitors And Suicide In Pediatrics : An Analysis Of US-FDA Adverse Event Reporting System (FAERS)
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| Author:
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, NADA ALA ELDDEN ALAZZEH
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| Abstract:
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Introduction: SSRIs are used for the management of mental disorders in pediatrics. Recent data showed a possible increased risk of suicidal behavior and activation syndrome (AS) among pediatrics treated with SSRIs. Furthermore, off-label use of SSRIs is highly prevalent and can expose patients to several ADEs including the risk of suicidal behavior and AS.
Aims: To explore the risk of suicidal behavior and AS associated with the use of SSRIs in pediatrics and to examine the association between off-label use of SSRIs in pediatrics and adverse events
Method: A total of 11 647 ICSRs in pediatric reporting on SSRIs as primary suspected drug were between 2010 and 2016 were extracted from FAERS. Both indications and reported adverse events were classified according to the ICD10. Age was classified according to the ICH. Off-label was defined as indicated in SPC. Several associations were compared using chi-square test. A P-value less than 0.05 is considered statistically significant.
Results: A total of 1249 primary cases were included in the final analysis. Overall, 78.7% were off-label. The association between off-label drug use and several covariates were statistically significant (p-values >0.005). Overall, 17.2% and 5.7%of the included reports were reported as suicidal behavior and AS respectively. The association between the reported adverse events and different covariates were statistically significant (p-values >0.000).
Conclusion: There was a strong association between suicidal behavior, AS, and Off-label drug use with different covariates. And these adverse events were more likely to be implicated in serious adverse events.
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| Keyword:
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SSRIs; Pediatrics; Suicidal behavior; Activation syndrome; Off-label; FAERS.
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.03.138
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| Download:
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