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FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions

FDA Drug Safety Podcast

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Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.

On May 11, 2023, the FDA is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the entire class of stimulant medicines. 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. 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.

Prescription stimulants can be an important treatment option for disorders for which they are indicated. However, even when prescribed to treat an indicated disorder, their use can lead to misuse or abuse. 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. 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.

We are requiring the Boxed Warning, FDA’s most prominent warning, to be updated and we are adding other information to the prescribing information for all prescription stimulants. We are adding information that patients should never share their prescription stimulants with anyone, and the Boxed Warning information will describe the risks of misuse, abuse, addiction, and overdose consistently across all medicines in the class. The Boxed Warning also will advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.

Information on these risks is being required in several sections of the prescribing information, including the Warnings and Precautions, Drug Abuse and Dependence, Overdosage, and Patient Counseling sections. We are also requiring updates to the existing patient Medication Guides to help educate patients and caregivers about these risks.

Health care professionals should 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. Throughout treatment, regularly assess and monitor them 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.

We reviewed the medical literature published from January 2006 to May 2020 on misuse and abuse of prescription stimulants and associated adverse events.

Our review found that nonmedical use has remained relatively stable over the past two decades, despite the increasing number of prescription stimulants dispensed. However, the past-year prevalence of nonmedical use of these medicines varies across specific subpopulations and is highest in the following groups: young adults ages 18 to 25, college students, and adolescents and young adults diagnosed with ADHD. According to the available data, people who use prescription stimulants for nonmedical reasons have a higher risk of developing a substance use disorder than those who do not. The most serious harms were more commonly observed with nonmedical use by a non-oral route such as snorting or injecting.

All medicines have side effects even when used correctly as prescribed. It is important to know that people respond differently to all medicines depending on their health, the diseases they have, genetic factors, other medicines they are taking, and many other factors. As a result, we cannot determine how likely it is that someone will experience these side effects when taking prescription stimulants.

Side effects involving prescription stimulants and other medicines should be reported to FDA’s MedWatch reporting program at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at Drug Safety Communications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov. And follow us on Twitter @FDA_Drug_Info. Thank you for listening.

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