FDA calls for clarity of Rx labeling for stimulants used for ADHA and other conditions

The US Food and Drug Administration (FDA) yesterday announced it 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 non-medical use), addiction, and overdose information. Non-medical 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.

The 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.