The FDA is updating its warnings for prescription stimulants used to treat ADHD and other conditions in an attempt to improve the safety of these widely prescribed medications.1
The updated boxed warnings will include information about the risks of abuse, misuse, addiction, and overdose, as well as language advising physicians to monitor patients closely for these risks. The updated warnings will be required on all medications in this class of stimulants.1 Commonly prescribed drugs in this class include amphetamine/dextroamphetamine (Adderall), methylphenidate (Concerta), dextroamphetamine (Dexedrine), and methylphenidate (Ritalin).
These medications, which can be beneficial if used appropriately, are indicated for the management of ADHD as well as eating disorders and narcolepsy. However, in recent years, there has been increased concern over the abuse and misuse of stimulants.
Nonmedical Use of Stimulants
The FDA’s move was based, in part, on a review of the medical literature published from January 2006 to May 2020 on nonmedical use of prescription stimulants. The reviewers found that 56% to 80% of prescription stimulants taken for nonmedical reasons were provided by family members and friends, usually for free. Only about 10% to 20% of people who used these drugs nonmedically used their own prescriptions. Drug dealers and strangers were even less common sources of stimulants used for nonmedical purposes. The internet accounted for 1% of drugs procured for nonmedical use.
While prescribing of these medicines has increased over the years – almost doubling in the past decade – the review found that nonmedical use remained relatively stable during that time. Nonetheless, the data were concerning. Nonmedical use was highest in young adults (ages 18 to 25), college students, and adolescents and young adults diagnosed with ADHD. Among the latter group, past-year prevalence of nonmedical use ranged from 14% to 32%.
Risk of Substance Use Disorder
The data also showed that people using prescription stimulants for nonmedical reasons are at higher risk than others of developing a substance use disorder (SUD). Those who use prescription stimulants nonmedically are also likely to use alcohol, marijuana, cocaine, and opioids, according to the review. The worst adverse events were the result of taking these drugs through a non-oral route.
The new labeling will advise clinicians who prescribe these medications to carefully assess the patient for risk of abuse and misuse. Patients should be counseled not to share their medicines with anyone else. Physicians are encouraged to educate both patients and families about the risks of these drugs as well as about how to properly store and dispose of any unused medicine. Prescribers and pharmacists should pay close attention to renewal requests beyond the prescribed dosage.
