FDA Requiring Updated Warning Labels for ADHD Medication
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The U.S. Food and Drug Administration is updating warnings for prescription stimulants used to treat attention-deficit/hyperactivity disorder, or ADHD, and other conditions. According to the federal agency, more cautions about the potential for misuse and abuse of the medication, as well as the risks of addiction, are needed.
New boxed warnings will be added to an entire class of central nervous system stimulants because most of the current warnings are out of date. These prescription medications will see new standardized language addressing the risk of abuse, overdose, addiction, misuse and death.
The current warning reads, “potential for abuse and dependence.” The new warning will read “Warning: Abuse, misuse, and addiction.” New labels will also remind health care professionals to monitor patients for obvious signs of abuse or addiction.
These warnings will be found on amphetamines commonly prescribed for ADHD treatment, including:
- Adderall
- Concerta
- Dexedrine
- Focalin
- Metadate
- Ritalin
- Vyvanse
New labels will also warn users about overdose and death if the drug is being misused by snorting it, injecting it or taking too much at one time.
The Citizens Commission on Human Rights, a nonprofit watchdog group, calls the FDA’s warning label update long overdue. It claims the agency still hasn’t done enough to address the potential risks of stimulant drugs.
Side Effects of Abuse and Misuse
The medications receiving new warning labels work by stimulating the body’s central nervous system. These drugs increase chemicals in the brain, such as dopamine and norepinephrine, to treat symptoms of ADHD.
Serious and sudden health effects can develop if the stimulants are misused or abused. Some of the side effects of abusing ADHD medications include:
- Anxiety
- Depression
- High body temperatures
- Irregular heartbeat
- Paranoia
- Psychosis
- Seizures
The effects are amplified if taken in large doses, according to the Substance Abuse and Mental Health Services Administration. Research also shows a correlation between those who misuse ADHD medications and multiple substance use disorders.
Researchers say about one out of every nine high school seniors will be prescribed stimulants to treat the condition during their lifetime. A teen prescription stimulant study published in April 2023 in the Journal of the American Medical Association found that schools with higher rates of students who are prescribed ADHD drugs are more likely to have nonmedical misuse or abuse the drugs.
Increasing Use Leads to ADHD Medication Shortage
More than 9.5 million people nationwide are prescribed ADHD medication, many of them children and teenagers. ADHD diagnoses have been rising at a fast rate over the last 20 years, which means more people are being prescribed medication to treat the disorder.
A nationwide shortage of the ADHD medication Adderall began across the U.S. in late 2022 during the COVID-19 pandemic and continued into 2023. Supply issues have improved since, but many pharmacies still have a hard time keeping the drug in stock. The lack of supply is forcing many people to find alternatives, which also causes the generic version of the drug to become harder to find.
In June 2023, FDA Commissioner Robert M. Califf claimed that the Adderall shortage was due to overprescribing the drug. Califf suggested that not everyone using the medication may truly need it. He also blamed telehealth providers for the large increase in ADHD diagnoses and stimulant prescriptions over the past few years.
“If only the people that needed these drugs got them, there probably wouldn’t be a shortage,” Califf said. “There’s a large amount of use which is on the margins. And this is why we need better clinical standards.”