FDA requires updates to clarify labeling of prescription stimulants used to treat ADHD and other conditions

[May 11, 2023] FDA is requiring sponsors of amphetamine and methylphenidate products, a class of stimulant medications used to treat attention deficit/hyperactivity disorder (ADHD) and other disorders, to update and standardize their prescribing information to clearly inform patients, caregivers and health care professionals of risks associated with their medications.

The required updates will address misuse and abuse (also called nonmedical use), addiction, and overdose information. Nonmedical use can include using someone else’s medication or taking your own medication differently than prescribed. The agency is also requiring consistent language that patients should never share their prescription stimulants with anyone.

“FDA is requiring these updates in the prescribing information to give patients, caregivers, and health care professionals more clarity on how to responsibly and safely use stimulant medications for ADHD and other conditions,” said Tiffany Farchione, M.D., FDA’s director of the Division of Psychiatry in CDER’s Office of New Drugs. “This action is part of our ongoing efforts to minimize nonmedical use, addiction, overdose and the sharing of medications.”

FDA is also requiring more consistent information for health care professionals to assess and monitor each patient’s risks for misuse, abuse and addiction before prescribing and while patients are taking these medications. This information will help educate patients and caregivers about serious risks, including proper storage and disposal of their unused medication.

Prescription stimulants can be an important option for treating disorders for which these medicines are indicated. They are used to treat ADHD, binge-eating disorder and uncontrollable episodes of deep sleep called narcolepsy. These medicines can benefit patients when used appropriately. However, even when prescribed to treat a specific condition, their use can lead to misuse or abuse.

All required safety labeling changes are listed in the Drug Safety Communication.