paroxetine

Last reviewed 01/2018

Paroxetine is a selective 5HT uptake blocker, with sleep slightly improved by administration in the morning.

Licensed indications in the UK:

  • depressive illnes
  • obsessive-compulsive disorder
  • panic disorder
  • social phobia
  • post-traumatic stress disorde
  • generalised anxiety disorder

The usual initial dosage is 20 mg mane; the dose-response curve plateaus at 20 mg although doses may be given up to 50 mg in the treatment of depressive illness, panic disorder and social phobia (a maximum dose of 60 mg per day is licensed in the UK for the treatment of obsessive compulsive disorder).

Use of paroxetine in patients under 18 years of age:

Paroxetine is now contraindicated in patients with major depressive disorders under 18 years of age (1)

A recently completed programme of clinical trials in children and adolescents under 18 years og age failed to demonstrate efficacy in Major Depressive disorder and there was a doubling of the rate of reporting of adverse events in the paroxetine group compared to placebo, including: reduced appetite, tremor, sweating, hostility, hyperkinesia, agitation, emotional lability (including crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide)

Withdrawal Symptoms Associated with Paroxetine:

There has been recent controversy concerning the risk of withdrawal symptoms associated with paroxetine. A table of yellow card reports for suspected adverse drug reactions (ADRs) is presented below (data from Medicines Control Agency):

SSRI Total ADRs Drug withdrawal ADRs Year first licensed
paroxetine 8522 1325 1990
fluoxetine 7852 92 1988
sertraline 2348 81 1990
citalopram 1566 56
1995

In the UK, a meeting involving medicines experts, including members of the Government's Committee on Safety of Medicines, are to meet shortly regarding recent controversies concerning paroxetine.

The summary of product characteristics should be consulted before prescribing this drug.

Reference:

  1. letter from GlaxoSmithKline Re: Seroxat (paroxetine hydrochloride) - contraindication in children under 18 for the treatment of major depressive disorder (SRX/MLP/03/08454/1 - June 2003)
  2. BNF 4.3.3