FDA updates stimulant labelling requirements to reduce misuse

As the next step in the FDA’s efforts to reduce prescription drug deaths, the agency is requiring updates to the boxed warning and other information for attention deficit hyperactivity disorder (ADHD) prescription stimulants.

With this action, the FDA aims to continue addressing concerns of misuse, abuse, addiction, and overdose of amphetamine and methylphenidate products. The FDA is making this move to “clearly inform patients, caregivers and health care professionals of risks associated with their medications”.

The required changes will be made to the prescribing information in the “Warnings and Precautions”, “Drug Abuse and Dependence”, “Overdosage”, and “Patient Counselling” sections. Furthermore, current patient medication guides must now be updated, to raise awareness about the potential harms of these drugs to patients and caregivers.

With the FDA approval of non-prescription Narcan (naloxone) for over-the-counter use in March, US regulatory agencies have announced several initiatives in recent months to tackle the growing prescription drug death problem. The Centers for Disease Control reports that since 1999, over 932,000 US citizens have died due to drug overdoses. As opioids have recently centred the conversation surrounding anti-drug abuse methods, the FDA is also making an effort to reduce overdose risks in other major drug classes such as stimulants.

Prescription stimulants are used to treat ADHD, narcolepsy, and binge-eating disorder. According to the FDA update, current labels for these drugs do not have up-to-date warnings about the risks of drug misuse and abuse and fail to mention that most individuals who misuse prescription stimulants source drugs from other family members or peers. Furthermore, the FDA pointed out that sharing stimulants amongst peers can often be the beginning of a path to drug abuse.

According to the National Institute on Drug Abuse, all stimulants work by increasing brain dopamine levels, disrupting normal interaction between brain cells. Dopamine is a neurotransmitter linked to attention and pleasure. They state that the effects of the euphoric feeling associated with these drugs make users at high risk for addiction.

Common prescription stimulants include Adderall (amphetamine/dextroamphetamine), Johnson & Johnson’s Concerta (methylphenidate), GSK’s Dexedrine (dextroamphetamine), and Bristol-Myers Squibb’s Ritalin (methylphenidate). Prescription stimulants are available as capsules, tablets and liquid formulations.