The FDA now requires updated labeling for all extended-release stimulant medications used to treat attention deficit hyperactivity disorder, warning of increased risk of weight loss and other side effects in children younger than 6.
Though extended release tablets such as amphetamine and methylphenidate formulations are not FDA approved for patients younger than 6, they are sometimes prescribed off label, according to a June 30 agency news release.
Recent FDA analyses of clinical trial data showed that young patients had higher levels of the drugs in their system and a higher incidence of adverse effects in comparison to older children receiving the same dose.
To address this, the agency said it will require drug manufacturers to add or update a limitation-of-use section to make transparent the increased risk in children younger than 6.
