The antidepressant paroxetine (PAXIL) was approved for use in 1993. Th
us far, this selective serotonin reuptake inhibitor (SSRI) has shown a
high threshold for the development of toxic manifestations in adult o
verdoses. However, the toxic threshold doses and profile of toxic mani
festations for pediatric exposures has not been well-established. All
pediatric paroxetine exposures reported at a certified regional poison
information center over a 24-mo period were reviewed. The parameters
evaluated included age, amount, co-ingestants, symptoms, treatment and
outcome. Thirty-five pediatric paroxetine exposures were documented.
Ages ranged from 10.5 mo to 17 y. Paroxetine alone accounted for 28 ca
ses and 7 were with concommitant medications. Of the paroxetine-alone
ingestants, 16 cases were in children less than or equal to 5 y (mean
age 2.4 y) with ingestant amounts ranging from 10-120 mg. All patients
remained asymptomatic with or without gastrointestinal decontaminatio
n. The remainder of sole ingestant cases included 12 patients greater
than or equal to 12 y (mean age 17.2 y) who ingested 100-800 mg (mean
292 mg). Most remained asymptomatic. There were 7 patients in the co-i
ngestant group greater than or equal to 13 y. Only 2 remained asymptom
atic, but the symptoms reported were also consistent with the co-inges
tants taken. Paroxetine is less sedating and has fewer cardiovascular
effects than the tricyclic antidepressants, even in the pediatric popu
lation. The high therapeutic index is consistent with other SSRI's. In
contrast to more toxic antidepressants in the pediatric group, paroxe
tine overdose patients are less likely to develop toxic manifestations
. Ingestions of 120 mg or less in children less than or equal to 5 y l
ed to favorable outcomes following gastrointestinal decontamination an
d minimal supportive care. However, continued evaluation of paroxetine
is essential to determine more specific toxic thresholds.