Pattern of orlistat exposures in children aged 5 years or less.

On February 7, 2007, orlistat became the first weight-loss drug approved by the United States Food and Drug Administration for over-the-counter sales. However, information on exposures among young children is limited. The objective of this study was to describe the pattern of orlistat exposures among young children reported to poison control centers. The pattern of all exposures to orlistat alone among patients < or = 5 years old reported to six poison control centers during 1999-2005 was identified with respect to various factors. There were 107 cases. The average age was 21.4 months. There were 55 males, 51 females, and 1 unknown. The dose was identified for 76 cases. The mean dose was 155 mg. Patients were managed on site in 88% of the cases, were already at a health care facility in 8%, and were referred to a health care facility in 5%. Of the 45 patients with a known medical outcome, the outcome was no effect for 91% and minor effect for 9% of the patients. Of the 92 cases reported during 2000-2005, the listed adverse clinical effects were diarrhea (n = 4) and vomiting (n = 1), and the listed treatments were decontamination by dilution (n = 62), food (n = 8), activated charcoal (n = 5), other emetic (n = 2), cathartic (n = 1), and ipecac (n = 1). Orlistat exposures among young children involving small doses encountered by poison control centers can usually be managed on site through decontamination, and have favorable outcomes with few adverse clinical effects, mainly gastrointestinal in nature.