(Reuters) -The U.S. Food and Drug Administration said on Monday that it is revising the labeling of all extended-release stimulants to treat attention-deficit/hyperactivity disorder (ADHD) to warn about the risk of weight loss and other side effects in patients younger than six years.
The FDA said that it is requiring a “limitation of use” section in the prescribing information of all extended-release stimulants to include a statement on higher rates of adverse reactions in children younger than six years.
Extended-release stimulants are prescription drugs primarily used to treat ADHD as an initial therapy and come in a variety of dosage forms, including tablets, capsules and liquid suspensions.
Although extended-release stimulants are not approved for children younger than 6 years, health care professionals can prescribe them “off label” to treat ADHD.
(Reporting by Sneha S K in Bengaluru; Editing by Alan Barona)
