Important Safety Information
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and
behavior (suicidality) in children, adolescents, and young adults in short-term
studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone
considering the use of Zoloft or any other antidepressant in a child, adolescent,
or young adult must balance this risk with the clinical need. Short-term studies
did not show an increase in the risk of suicidality with antidepressants compared
to placebo in adults beyond age 24; there was a reduction in risk with antidepressants
compared to placebo in adults aged 65 and older. Depression and certain other psychiatric
disorders are themselves associated with increases in the risk of suicide. Patients
of all ages who are started on antidepressant therapy should be monitored appropriately
and observed closely for clinical worsening, suicidality, or unusual changes in
behavior. Families and caregivers should be advised of the need for close observation
and communication with the prescriber. Zoloft is not approved for use in pediatric
patients except for patients with obsessive compulsive disorder (OCD). |
ZOLOFT is contraindicated until at least 14 days have passed since discontinuing
a monoamine oxidase inhibitor (MAOI) and an MAOI is contraindicated for at least
14 days after discontinuation of ZOLOFT. Concomitant use in patients taking pimozide
is contraindicated.
Zoloft is approved to treat Major Depressive Disorder (MDD), Pre-Menstrual Dysphoric
Disorder (PMDD), Post Traumatic Stress Disorder (PTSD), Obessive Compulsive Disorder
(OCD), Panic Disorder and Social Anxiety Disorder. In children and adolescents (aged
6-17 years) ZOLOFT is only approved to treat OCD.
In adults, the most common side effects of ZOLOFT in depression and other premarketing
controlled trials for OCD, panic disorder, PTSD, PMDD, and social anxiety disorder
vs placebo include nausea (25% vs 11%), insomnia (21% vs 11%), diarrhea (20% vs
10%), dry mouth (14% vs 8%), ejaculation failure (primarily ejaculatory delay) (14%
vs 1%), somnolence (13% vs 7%), fatigue (12% vs 7%), tremor (8% vs 2%), dyspepsia
(8% vs 4%), libido decreased (6% vs 2%), increased sweating (7% vs 2%), anorexia
(6% vs 2%), and agitation (5% vs 3%).
ZOLOFT has been evaluated for safety in children and adolescents with MDD or OCD
for up to 1 year.* The overall profile of adverse events in pediatric patients was
generally similar to that seen in adult studies. In pediatric patients ZOLOFT is
only indicated for OCD.
The risks, if any, that may be associated with the use of ZOLOFT beyond 1 year in
children and adolescents have not been systematically assessed. Although there is
no affirmative finding suggesting effects on the growth, development, and maturation
of children and adolescents, the potential of ZOLOFT to have adverse effects with
chronic use is not known.
The use of ZOLOFT in patients with liver disease must be approached with caution.
If ZOLOFT is administered to patients with liver disease, a lower or less frequent
dose should be used.
*In approximately 600 pediatric patients (aged 6 to 17
years).