Withdrawal Syndrome Following Discontinuation of 28 Antidepressants: Pharmacovigilance Analysis of 31,688 Reports from the WHO Spontaneous Reporting Database

Chiara Gastaldon (), Georgios Schoretsanitis, Elena Arzenton, Emanuel Raschi, Davide Papola, Giovanni Ostuzzi, Ugo Moretti, Erich Seifritz, John M. Kane, Gianluca Trifirò and Corrado Barbui
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Chiara Gastaldon: University of Verona
Georgios Schoretsanitis: Northwell Health
Elena Arzenton: University of Verona
Emanuel Raschi: University of Bologna
Davide Papola: University of Verona
Giovanni Ostuzzi: University of Verona
Ugo Moretti: University of Verona
Erich Seifritz: University of Zurich
John M. Kane: Northwell Health
Gianluca Trifirò: University of Verona
Corrado Barbui: University of Verona

Drug Safety, 2022, vol. 45, issue 12, No 9, 1539-1549

Abstract: Abstract Introduction Evidence is lacking on withdrawal syndrome related to individual antidepressants and relevant risk factors for severe reactions. Objective To ascertain whether antidepressants are associated with an increased reporting of withdrawal syndrome as compared with other medications, and to investigate risk factors for severe reactions. Methods This is a case/non-case pharmacovigilance study, based on the VigiBase®, the WHO global database of individual case safety reports of suspected adverse drug reactions. We performed a disproportionality analysis of reports of antidepressant-related withdrawal syndrome (calculating reporting odds ratio [ROR] and Bayesian information component [IC]). We compared antidepressants to all other drugs, to buprenorphine (positive control), and to each other within each class of antidepressants (selective serotonin reuptake inhibitors [SSRIs], tricyclics and other antidepressants). Antidepressants with significant disproportionate reporting were ranked in terms of clinical priority. Serious versus non-serious reactions were compared. Results There were 31,688 reports of antidepressant-related withdrawal syndrome were found. A disproportionate reporting was detected for 23 antidepressants. The estimated ROR for antidepressants altogether, compared to all other drugs, was 14.26 (95% CI 14.08–14.45), 17.01 for other antidepressants (95% CI 16.73–17.29), 13.65 for SSRIs (95% CI 13.41–13.90) and 2.8 for tricyclics (95% CI 2.59–3.02). Based on clinical priority ranking, the strongest disproportionate reporting was found for paroxetine, duloxetine, venlafaxine and desvenlafaxine, being comparable to buprenorphine. Withdrawal syndrome was reported as severe more often in males, adolescents, persons in polypharmacy, and with a longer antidepressant treatment duration (p

Date: 2022
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DOI: 10.1007/s40264-022-01246-4

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