Silver Spring, MD—The FDA is now requiring an updated Boxed Warning and additional information to prescribing guidelines for all prescription stimulants, which are primarily used for treating attention-deficit/hyperactivity disorder (ADHD).

The new labeling will emphasize the risks of misuse, abuse, addiction, and overdose across all medicines in the class. It will also urge pharmacists and other healthcare professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.

Information on the risks will be added to several sections of the prescribing information, including the Warnings and Precautions, Drug Abuse and Dependence, Overdosage, and Patient Counseling sections. Medication guides will be updated as well.

“The current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers,” the FDA noted. “Further, individuals who are prescribed stimulants are often faced with requests to share their medication. Sharing these medicines with others can lead to development of substance use disorder and addiction in those with whom these drugs are shared.”

The agency pointed out that prescription stimulants can be an important treatment option for the disorders for which they are indicated. The growing concern is misuse or abuse, which the FDA’s website described as nonmedical use that “can include taking your own medicine differently than prescribed or using someone else’s medicine. For this reason, sharing prescription stimulants with those for whom they are not prescribed is an important concern and a major contributor to nonmedical use and addiction.”

The FDA warned that misuse and abuse of prescription stimulants can result in overdose and death, adding that the risk is increased with higher doses or unapproved methods of taking the medicine, such as snorting or injecting.

Healthcare professionals are asked to do the following:

• Assess patient risk of misuse, abuse, and addiction before prescribing stimulant medicines
• Counsel patients not to share their prescribed stimulant with anyone else
• Educate patients and their families on these serious risks, proper storage of the medicine, and proper disposal of any unused medicine
• Regularly assess and monitor patients for signs and symptoms of nonmedical use, addiction, and potential diversion, which may be evidenced by more frequent renewal requests than warranted by the prescribed dosage.

The drug safety communication advised that the FDA reviewed the medical literature published from January 2006 to May 2020 on misuse and abuse. It found that the most common source of prescription stimulants for nonmedical use in the general population came from friends or family members, with estimates generally ranging from 56% to 80%, usually provided for free. “Nonmedical use from their own prescription accounted for approximately 10 percent to 20 percent of people who report having used stimulants nonmedically in the past year,” the report noted. “Less commonly reported sources included drug dealers or strangers accounting for 4 percent to 7 percent of people who report having used stimulants nonmedically in the past year, and the internet accounting for 1 percent to 2 percent.”

Most likely to misuse or abuse stimulates are young adults aged 18 to 25 years (estimates ranged from 4.1%-7.5%), college students (4.3%), and adolescents and young adults diagnosed with ADHD (estimates ranged from 14%-32%).

The data pointed out that stimulant abuse or misuse increases the risk of developing a substance use disorder, among other harms.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

« Click here to return to Weekly News.