[Serious psychological side effect in children taking high doses of deptropine]

Since 1986 the Netherlands Centre for Monitoring of Adverse Reactions to Drugs has received 16 reports concerning psychic effects attributed to the use of deptropine citrate (Brontine) in children ranging from one to ten years of age. Within 1 to 3 days after starting treatment with a daily dose of 0.6-3 mg, hallucinations appeared in 7 children, aggressive behaviour and/or agitation in 6 children, ataxia in 2 children, and anxiety in 1 child. In none of these cases could another cause be found. In one patient symptoms persisted during the whole 15-month period of treatment. All patients recovered rapidly after discontinuation of deptropine citrate. As it probably concerns a dose-dependent effect and because most patients had been prescribed a daily dose of 0.06 mg/kg body weight, it is strongly advised to exceed the recommended daily dose of 0.03 mg/kg body weight as little as possible.