P R AC T I C E H E A LT H AND DRUG ALERTS

Paroxetine (Paxil, Seroxat): increased risk of suicide

in pediatric patients
Reason for posting: Mood and anxiety tion recently reviewed additional safety paroxetine-associated pediatric adverse
disorders are often managed with se- and efficacy data for the use of paroxe- events reported to Health Canada be-
lective serotonin reuptake inhibitors tine in pediatric populations (www.fda tween 1993 and Apr. 30, 2003, were be-
(SSRIs) such as paroxetine because of .gov/bbs/topics/ANSWERS/2003/ANS cause of suicidal ideation.
their presumed efficacy and positive 01230.html). The pooled results of 3
safety profile.1–4 However, recent pla- unpublished trials involving pediatric What to do: Paroxetine is contraindi-
cebo-controlled trials have revealed patients with major depressive disorder cated for patients under the age of 18.
concerns about paroxetine’s efficacy failed to show paroxetine to be more ef- Although patients with mood disorders
and safety in the pediatric population. ficacious than placebo.5 In addition, the often require careful supervision be-
These concerns led the drug’s manu- pooled results showed that suicidal cause of an inherent risk of suicide,
facturer, GlaxoSmithKline, to issue thoughts, suicide attempts and episodes any pediatric patient currently taking
“Dear Health Care Professional” let- of self-harm were more frequent among paroxetine should be screened for suici-
ters in several countries, including the the paroxetine users (5.3% of 378 chil- dal thoughts, suicide attempts or
United States, the United Kingdom dren) than among those in the placebo episodes of self-harm. Serious consider-
and Canada.5 group (2.8% of 285 children).5 In a sep- ation should be given to changing ther-
arate placebo-controlled trial involving apies in all pediatric patients except
The drug: Paroxetine is the ninth most children with social anxiety disorder, those who have nearly completed suc-
commonly prescribed drug in Canada, 2.4% of the 165 children given paroxe- cessful courses. The drug should not be
with over 3 million prescriptions filled in tine had suicide-related adverse events discontinued abruptly (this can lead to
2002 (www.imshealthcanada.com/htmen as compared with none of 157 children serious SSRI withdrawal symptoms);7
/1_0_5.htm). It is a potent 5-HT recep- given a placebo.5 The safety of the drug rather, a gradual tapering of the dose is
tor inhibitor and is partly metabolized in the contexts of social anxiety disorder recommended. The relative safety of
by cytochrome P450 (2D6).6 It is indi- and obsessive–compulsive disorder in other antidepressants and SSRIs in pe-
cated for the treatment of depression, children and adolescents is currently be- diatric populations is unclear. The cur-
obsessive–compulsive disorder, panic ing investigated further. rent warnings do not apply to adult
disorder, social phobia, generalized anxi- No completed suicides have been re- users of paroxetine.
ety disorder and post-traumatic stress ported in GlaxoSmithKline’s pediatric
disorder in adults6 and is often used off- clinical trial program for children tak- Eric Wooltorton
label in pediatric populations.5 ing paroxetine, nor have any been re- CMAJ
The US Food and Drug Administra- ported in Canada. About 1% of the
References
1. Remick RA. Diagnosis and management of de-
pression in primary care: a clinical update and
review [review]. CMAJ 2002;167(11):1253-60.
Canadian Adverse Reaction Newsletter 2. Hazell P. Depression in children and adolescents
Bulletin canadien des effets indésirables 3.
[review]. Am Fam Physician 2003;67(3):577-9.
Son SE, Kirchner JT. Depression in children and
To receive the Newsletter and health product Advisories by email, adolescents. Am Fam Physician 2000;62(10):2297-
308, 2311-2.
join Health Canada’s Health_Prod_Info mailing list. 4. Ryan ND. Medication treatment for depression in
Go to www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/adr.html and click on "subscribe." children and adolescents. CNS Spectr 2003;8:283-7.
5. Important drug warning: Until further information
Inscrivez-vous à la liste Info_Prod_Santé de Santé Canada pour recevoir par is available, Paxil® (paroxetine hydrochloride)
courriel le Bulletin et les Avis au sujet des produits de santé. Rendez-vous à l’adresse should not be used in children and adolescents un-
www.hc-sc.gc.ca/hpb-dgps/therapeut/htmlfrn/adr.html et cliquez sur « abonnement ». der 18 years of age [Dear Health Care Professional
Letter]. Mississauga (ON): GlaxoSmithKline Inc.;
Report adverse reactions toll free to Health Canada July 2003. Available: www.hc-sc.gc.ca/hpfb-
dgpsa/tpd-dpt/paxil_e.html (accessed 2003 Aug 5).
Signaler sans frais des effets indésirables à Santé Canada 6. Paxil [product monograph]. In: Compendium of
Tel./Tél. : 866 234-2345 • Fax/Téléc. : 866 678-6789 pharmaceuticals and specialties. Ottawa: Canadian
Pharmacists Association; 2003. p. 1255-60.
Email/Courriel: cadrmp@hc-sc.gc.ca 7. Green B. Focus on paroxetine. Curr Med Res
Opin 2003;19(1):13-21.

446 JAMC • 2 SEPT. 2003; 169 (5)

© 2003 Canadian Medical Association or its licensors