FDA Updates Warnings on All Stimulants for ADHD, Other Conditions

The FDA is updating warnings for stimulants prescribed for attention-deficit/hyperactivity disorder (ADHD) and other conditions, citing concerns about nonmedical use of the drugs.

In a drug safety communication on Thursday, the agency said the boxed warning for the entire class of central nervous system stimulants would get standardized language to more clearly state the dangers — including the risk for misuse, abuse, addiction, overdose, and death — given that most of the current warnings are out of date. This class of drugs includes amphetamines such as Adderall and methylphenidate such as Ritalin and Concerta.

For example, the current warning of a “Potential for abuse and dependence” will be revised to “Warning: Abuse, misuse, and addiction,” and the new labeling will warn of overdose and death in the event of misuse, especially with higher doses, snorting, or injection.

“Most individuals who misuse prescription stimulants get their drugs from other family members or peers,” the FDA wrote. “Further, individuals who are prescribed stimulants are often faced with requests to share their medication.”

In fact, a review of medical literature from 2006 to 2020 by the agency found that 56% to 80% of nonmedical stimulant use involved drugs provided free to friends or family, while nonmedical use from someone’s own prescription accounted for about 10% to 20% of the misuse. Drug dealers, strangers, and the internet accounted for only small percentages.

But even while the number of stimulant prescriptions has increased over the past two decades, nonmedical use has remained relatively stable, the agency noted. The highest past-year prevalence of nonmedical use was seen among adolescents and young adults diagnosed with ADHD (14% to 32%) and individuals ages 18 to 25 overall (4.1% to 7.5%).

New language in the labeling will instruct healthcare providers to assess patients’ risk for abuse before prescribing a stimulant for ADHD or other conditions, to “frequently monitor for signs and symptoms of abuse, misuse, and addiction,” following a prescription, and to educate patients and their families about storing drugs safely and on not sharing the medications.

Updated and new language will also include details about physical symptoms of abuse and withdrawal from stimulants, clinical effects of overdose, overdose management, and diversion prevention.

And though the agency reported that deaths involving stimulants continue to rise, and often involve multiple substances, deaths involving “illicit stimulants or opioids” still outnumber deaths involving prescription stimulants.