FDA Wants Updated Labeling on Some Stimulants

FDA says it is requiring sponsors of amphetamine and methylphenidate products used to treat attention deficit/hyperactivity disorder and other disorders to update and standardize their prescribing information to clearly inform patients, caregivers, and healthcare professionals of the risks associated with the medications. An online notice says 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 also is requiring consistent language that patients should never share their prescription stimulants with anyone.”

The agency is also requiring more consistent information for healthcare professionals to assess and monitor each patient’s risks for misuse, abuse, and addiction before prescribing and while patients are taking the medications.