FDA Warns: Weight Loss Risk in Young Children on ADHD Medications

Based on recent FDA findings the use of extended-release stimulants for ADHD management in children below 6 years old has been causing weight loss & other adverse events which has made the FDA concerned about the benefit the medication has to offer over the serious side effects it can have on the patients. Although extended-release stimulants are not approved for children younger than 6 years, health care professionals can prescribe them “off label” to treat ADHD.

Hence, FDA has been obligating pharma companies to add a limitation of use in product label highlighting the potential adverse events associated with the use of these products in children younger than 6 years old. In the meanwhile, the FDA has brought to attention & warning the public that if they find their children with excessive weight loss to stop medication & reach out for a healthcare professional. Where they can adjust dosage or switch on to another medication that can be immediate release. Since immediate-release stimulants have a shorter duration in the body, their dosage timing and frequency can be adjusted to help minimize effects on appetite and sleep. Additionally, behavioral therapy is a valuable treatment option for managing ADHD.

All medicines can cause side effects, and individual responses vary based on health status, genetics, and other medications. This makes it difficult to predict who might experience issues like weight loss. Patients and healthcare professionals are encouraged to report any side effects, including those related to extended-release stimulants, to the FDA MedWatch program.

Learn more: FDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHD | FDA