Fluoxetine exposures: are they safe for children?

Although it is generally believed that unintentional ingestions of fluoxetine by children are relatively safe, there are no large published studies supporting this concept. The goal of this retrospective study is to determine the signs and symptoms of these children. Inclusion criteria included fluoxetine exposures from six certified regional poison centers: <6 years old, known amount, single substance, 20 mg or more ingested, and follow up done to determine outcome. One hundred twenty cases met all inclusion criteria. Average age was 25 months ± 12 months. Median amount ingested was 20 mg. Mild signs and symptoms were noted in 3.3%, and no major signs or symptoms were reported. In 48 cases, a milligram per kilogram dose was calculated, and the median dose ingested was 2.26 mg/kg. In 92% of the cases, the amount ingested was 60 mg or below. These children will have no adverse effects or only minimal effects and require no emergency treatment or gastric decontamination.