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Pharmacist handing prescription to patient

FDA updating prescription stimulant warnings to address misuse, abuse

May 12, 2023

Health officials are updating warnings on prescription stimulants to provide information on the risks of misusing or sharing the medications.

Prescription stimulants are used to treat attention-deficit/hyperactivity disorder (ADHD) as well as binge-eating disorder and narcolepsy. However, nonmedical use like taking more than prescribed or taking someone else’s prescription can be dangerous.

“Misuse and abuse of prescription stimulants can result in overdose and death, and this risk is increased with higher doses or unapproved methods of taking the medicine such as snorting or injecting,” the Food and Drug Administration (FDA) said in a new drug safety communication.

In addition to updating the warnings on the medications, the FDA is adding more guidance to the prescribing information and medication guides. The FDA recommends health care professionals assess patients’ risk of misuse, abuse and addiction and monitor them for signs of nonmedical use. Clinicians also should counsel patients on proper use, safe storage and disposal, signs of an overdose and the importance of not sharing the medications.

Patients should take their medications as prescribed, store them where they can’t be accessed by children, dispose of unused prescriptions immediately and never share them, according to the FDA. They also should speak to a health care provider if they are struggling with misuse or abuse and seek emergency medical care if they experience overdose symptoms like tremors, seizures, aggressive behavior, overactive reflexes, fast breathing, fast or irregular pulse rate, confusion, stomach cramps, heart attack or stroke.

Despite increases in stimulant prescriptions, nonmedical use has been relatively stable over the past two decades. Still, health officials are concerned. An estimated 4%-8% of young adults and 4% of college students misuse or abuse stimulants, according to research cited by the FDA. Nonmedical use rates are about 14%-32% for adolescents and young adults with ADHD. Family and friends are the most common source of prescription stimulants for nonmedical use.

A recent study from the University of Michigan supported by the National Institute on Drug Abuse found that across 3,284 U.S. secondary schools, prevalence of nonmedical use of prescription stimulants ranged from 0% to 25% of students. Schools with the highest percentages tended to have higher numbers of stimulant prescriptions, highly educated parents, high proportions of White students and medium levels of binge drinking. They tended to be located in suburban areas and regions other than the Northeast.

“The key takeaway here is not that we need to lessen prescribing of stimulants for students who need them, but that we need better ways to store, monitor, and screen for stimulant access and use among youth to prevent misuse,” study author Sean Esteban McCabe, Ph.D., said in a press release. “There’s variation in stimulant misuse across different schools, so it’s important to assess schools and implement personalized interventions that work best for each school. It’s also critical to treat and educate teens on prescription stimulants as the medications they are intended to be and limit their availability as drugs of misuse.”

Some manufacturers of ADHD medicine Adderall and generic amphetamine mixed salts tablets have been reporting shortages of the drugs since last fall, citing increased demand or shortages of the active ingredient. Estimated availability for medications from each manufacturer is available on the FDA website. An AAP expert also has provided information on other treatment options while the shortage continues. Clinicians should report drug shortage or supply issues to the FDA.



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