The Spanish Agency for Medicines and Health Products (AEMPS) has reported on the existence of serious cases of accidental overdose with risperidone in pediatric population due to errors in the interpretation of syringes or pipettes that accompany the medication. Risperidone is an atypical antipsychotic generally indicated for the treatment of schizophrenia, bipolar disorder and autistic disorder. In children and adolescents, it is indicated in the symptomatic treatment in the short term (up to 6 weeks) of behavioral problems such as aggressiveness, autolesions or sudden humor changes. The risperidone is used in children in the symptomatic treatment of aggressiveness in this population, between 5 and 16 years, the oral solution is frequently used, but the erroneous interpretation of the decimals and the variability between the different dosers, has caused cases of administration of ten times the scheduled pediatric dose, which ranges between 0.25 and 1.5 ml. According to the European Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), which has reviewed the notifications of medication errors and accidental overdose with risperidone, most of the cases notified (74%) were serious, and those affected have an average age of 8.8 years. Lee also Celeste López The AEMPS recalls the need to seek immediate medical attention if an overdose occurs, whose symptoms of including drowsiness, sedation, tachycardia, hypotension, extrapyramidal symptoms (involuntary movements such as tremors or spasms, or postural disorders), extension of the QT interval (rapid increase in heart rate) and seizures. In order to avoid errors in the interpretation of the dosing, the AEMPS recommends to caregivers and patients to follow the instructions for use indicated in the prospect: “Pay attention to measure a small dose. For example, in solutions of 1mg/ml, to administer 0.25 mg it is necessary Syringe or pipette with water after each use and let it dry in the air. warns.
