title: Paroxetine: safety and tolerability issues.
abstract: Paroxetine is a selective serotonin re-uptake inhibitor (SSRI) available in immediate release and controlled release (CR) formulations. Paroxetine is the most potent inhibitor of serotonin re-uptake among the now available SSRIs. Paroxetine has been approved for the treatment of major depressive disorder (MDD), obsessive-compulsive disorder, panic disorder (PD), generalised anxiety disorder, post traumatic stress disorder (PTSD), and social anxiety disorder (SAD) in adults, whereas paroxetine CR is approved for the treatment of MDD, SAD, PD and premenstrual dysphoric disorder in adults. The overall efficacy of paroxetine seems to be comparable to other SSRIs in the treatment of approved indications, although paroxetine treatment induces more sedation, constipation, sexual dysfunction, discontinuation syndrome and weight gain than other SSRIs. Recent data suggest that paroxetine treatment leads to increased rates of congenital malformations, although this evidence is not conclusive. Paroxetine and paroxetine CR are not indicated for use in the paediatric population and are categorised as Pregnancy Class D. In conclusion, whether the tolerability profile of paroxetine differs substantially from other new antidepressants (including other SSRIs) needs to be determined in adequately powered well-designed randomised controlled comparative clinical trials.
authors.affiliation: Duke University Medical Center, Department of Psychiatry and Behavioural Sciences, 2218 Elder Street, Durham 27705, USA.
authors.forename: David M
authors.initials: DM
authors.lastname: Marks
authors.forename: Min-Hyeon
authors.initials: MH
authors.lastname: Park
authors.forename: Byung-Joo
authors.initials: BJ
authors.lastname: Ham
authors.forename: Changsu
authors.initials: C
authors.lastname: Han
authors.forename: Ashwin A
authors.initials: AA
authors.lastname: Patkar
authors.forename: Prakash S
authors.initials: PS
authors.lastname: Masand
authors.forename: Chi-Un
authors.initials: CU
authors.lastname: Pae
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D002648:Child; D002986:Clinical Trials as Topic; D003692:Delayed-Action Preparations; D004347:Drug Interactions; D005260:Female; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy*; D017374:Paroxetine / Q000008:administration & dosage / Q000009:adverse effects*; D011247:Pregnancy; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D003692:Delayed-Action Preparations; D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors