Paroxetine

Safety and tolerability issues

David M. Marks, Min Hyeon Park, Byung-Joo Ham, Changsu Han, Ashwin A. Patkar, Prakash S. Masand, Chi Un Pae

Research output: Contribution to journalArticle

36 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)783-794
Number of pages12
JournalExpert Opinion on Drug Safety
Volume7
Issue number6
DOIs
Publication statusPublished - 2008 Nov 1

Fingerprint

Paroxetine
Safety
Panic Disorder
Major Depressive Disorder
Serotonin Uptake Inhibitors
Therapeutics
Obsessive-Compulsive Disorder
Constipation
Post-Traumatic Stress Disorders
Anxiety Disorders
Antidepressive Agents
Weight Gain
Randomized Controlled Trials
Pediatrics
Pregnancy

Keywords

  • Newer antidepressants
  • Paroxetine
  • Paroxetine safety
  • Selective serotonin re-uptake inhibitor
  • Tolerability

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Marks, D. M., Park, M. H., Ham, B-J., Han, C., Patkar, A. A., Masand, P. S., & Pae, C. U. (2008). Paroxetine: Safety and tolerability issues. Expert Opinion on Drug Safety, 7(6), 783-794. https://doi.org/10.1517/14740330802423168

Paroxetine : Safety and tolerability issues. / Marks, David M.; Park, Min Hyeon; Ham, Byung-Joo; Han, Changsu; Patkar, Ashwin A.; Masand, Prakash S.; Pae, Chi Un.

In: Expert Opinion on Drug Safety, Vol. 7, No. 6, 01.11.2008, p. 783-794.

Research output: Contribution to journalArticle

Marks, DM, Park, MH, Ham, B-J, Han, C, Patkar, AA, Masand, PS & Pae, CU 2008, 'Paroxetine: Safety and tolerability issues', Expert Opinion on Drug Safety, vol. 7, no. 6, pp. 783-794. https://doi.org/10.1517/14740330802423168
Marks, David M. ; Park, Min Hyeon ; Ham, Byung-Joo ; Han, Changsu ; Patkar, Ashwin A. ; Masand, Prakash S. ; Pae, Chi Un. / Paroxetine : Safety and tolerability issues. In: Expert Opinion on Drug Safety. 2008 ; Vol. 7, No. 6. pp. 783-794.
@article{7dae3b53c91b4215bc6357026d5e31a0,
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.",
keywords = "Newer antidepressants, Paroxetine, Paroxetine safety, Selective serotonin re-uptake inhibitor, Tolerability",
author = "Marks, {David M.} and Park, {Min Hyeon} and Byung-Joo Ham and Changsu Han and Patkar, {Ashwin A.} and Masand, {Prakash S.} and Pae, {Chi Un}",
year = "2008",
month = "11",
day = "1",
doi = "10.1517/14740330802423168",
language = "English",
volume = "7",
pages = "783--794",
journal = "Expert Opinion on Drug Safety",
issn = "1474-0338",
publisher = "Informa Healthcare",
number = "6",

}

TY - JOUR

T1 - Paroxetine

T2 - Safety and tolerability issues

AU - Marks, David M.

AU - Park, Min Hyeon

AU - Ham, Byung-Joo

AU - Han, Changsu

AU - Patkar, Ashwin A.

AU - Masand, Prakash S.

AU - Pae, Chi Un

PY - 2008/11/1

Y1 - 2008/11/1

N2 - 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.

AB - 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.

KW - Newer antidepressants

KW - Paroxetine

KW - Paroxetine safety

KW - Selective serotonin re-uptake inhibitor

KW - Tolerability

UR - http://www.scopus.com/inward/record.url?scp=57049138975&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=57049138975&partnerID=8YFLogxK

U2 - 10.1517/14740330802423168

DO - 10.1517/14740330802423168

M3 - Article

VL - 7

SP - 783

EP - 794

JO - Expert Opinion on Drug Safety

JF - Expert Opinion on Drug Safety

SN - 1474-0338

IS - 6

ER -