The US Food and Drug Administration (FDA) has announced new action to address ongoing concerns about misuse, abuse, addiction, and overdose of prescription stimulants used to treat attention-deficit/hyperactivity disorder (ADHD).
“The current prescribing information for some prescription stimulants does not provide up to date warnings about the harms of misuse and abuse, floxin syrup and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers,” the FDA said in a drug safety communication.
Going forward, updated drug labels will clearly state that patients should never share their prescription stimulants with anyone, and the boxed warning will describe the risks of misuse, abuse, addiction, and overdose consistently for all medicines in the class, the FDA said.
The boxed warning will also advise heathcare professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.
Patient medication guides will be updated to educate patients and caregivers about these risks.
The FDA encourages prescribers to assess patient risk of misuse, abuse, and addiction before prescribing a stimulant and to counsel patients not to share the medication.
Friends and Family
A recent literature review by the FDA found that friends and family members are the most common source of prescription stimulant misuse and abuse (nonmedical use). Estimates of such use range from 56% to 80%.
Misuse/abuse of a patient’s own prescription make up 10% to 20% of people who report nonmedical stimulant use.
Less commonly reported sources include drug dealers or strangers (4% to 7% of people who report nonmedical use) and the internet (1% to 2%).
The groups at highest risk for misuse/abuse of prescription stimulants are young adults aged 18 to 25 years, college students, and adolescents and young adults who have been diagnosed with ADHD, the FDA said.
As previously reported by Medscape Medical News, recent data from the Centers for Disease Control and Prevention show that during the first year of the COVID-19 pandemic, prescriptions for stimulants increased 10% among older children and adults.
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