FDA Updates Warning on Stimulants Prescribed for ADHD, Now Lists Risks of Misuse, Addiction, Diversion and Overdose


Citizens Commission on Human Rights, National Affairs Office

WASHINGTON, DC, May 18, 2023 — The U.S. Food and Drug Administration (FDA) is requiring new warnings in the prescribing information for stimulant drugs used to treat so-called attention-deficit hyperactivity disorder (ADHD) “to address continuing concerns of misuse, abuse, addiction, and overdose of the prescription drugs,” according to the FDA’s statement on the change. The “boxed warning” being updated is the most prominent warning the FDA can require for drugs.

Stimulants commonly prescribed for ADHD that will now carry the elevated warning include Adderall, Concerta, Dexedrine, and Ritalin. The U.S. Drug Enforcement Agency (DEA) classifies these drugs as Schedule II controlled substances – the same drug classification as for cocaine, morphine, oxycodone, and fentanyl. The DEA warns that use of stimulant drugs can lead to “severe psychological or physical dependence” and that “these drugs are also considered dangerous.” Diversion of the drugs is illegal.

In explaining its reason for the heightened warning, the FDA states, “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.”

Diversion of prescribed stimulant drugs from patients to others is a longstanding problem, particularly among children and young adults. Research has found that a range of 16% to 29% of students from grade school through college who have stimulant prescriptions are asked to give, sell, or trade their medications.

The FDA’s new warning for stimulants reads, in part: “WARNING: ABUSE, MISUSE, AND ADDICTION. [Name of drug] has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS [central nervous system] stimulants, including [Name of drug], can result in overdose and death.”

The latest figures from the Centers for Disease Control and Prevention (CDC) show that overdose deaths from stimulant drugs have tripled from 10,255 deaths in 2017 to 32,478 in 2022. This increase is occurring in the context of a national overdose crisis, in which stimulants are increasingly involved, according to the CDC.

The FDA’s communication lists some of the serious side effects of stimulant drugs that require emergency treatment, including fast heart rate, fast breathing, increased blood pressure, restlessness, tremors, loss of coordination, nausea and vomiting, aggressive behavior, panic, confusion, and hallucinations. Stimulants are also linked to stunted growth in children.

Some 9.6 million Americans are prescribed stimulant drugs for so-called ADHD. However, there is no objective, scientific basis for “diagnoses” of mental disorders, as acknowledged by Thomas Insel, M.D., former director of the National Institute of Mental Health (NIMH), in his blog on the NIMH website in 2013. This means it is far too easy to “diagnose” ADHD.

The late psychologist Keith Conners conducted the first formal trials on the now-widely prescribed ADHD stimulant methylphenidate, commonly sold under the brand names Ritalin and Concerta. He later realized that ADHD diagnoses were out of control and called ADHD misdiagnoses “a national disaster of dangerous proportions.”

One in three Americans taking ADHD drugs is under the age of 18, but research has raised concerns over prescribing stimulants to children. Beyond the risks of serious adverse effects, a recent study found no convincing evidence of any long-term benefit to children from treatment for ADHD with stimulant drugs.

Another recent study found that children started on ADHD treatment with the stimulant methylphenidate were 18 times more likely to experience depression than before starting, and when the drug was discontinued, the higher risk dropped back to starting levels. [1]

Children who were first prescribed methylphenidate between the ages of 6 and 8 and continued to take the drugs had a 50% higher risk of being prescribed antidepressants for depression during their teen years, another study found. [2]

CCHR continues to raise public awareness of the risks of serious side effects and withdrawal symptoms from psychostimulants and other psychiatric drugs, so consumers and their physicians can make fully informed decisions about starting or stopping the drugs. CCHR supports safe and science-based non-drug approaches to mental health.

WARNING: Anyone wishing to discontinue or change the dose of an ADHD drug or any other psychiatric drug is cautioned to do so only under the supervision of a physician because of potentially dangerous withdrawal symptoms.

The Citizens Commission on Human Rights was co-founded in 1969 by members of the Church of Scientology and the late psychiatrist and humanitarian Thomas Szasz, M.D., recognized by many academics as modern psychiatry’s most authoritative critic, to eradicate abuses and restore human rights and dignity to the field of mental health. CCHR has been instrumental in obtaining 228 laws against psychiatric abuse and violations of human rights worldwide.

The CCHR National Affairs Office in Washington, DC, has advocated for mental health rights and protections at the state and federal level. The CCHR traveling exhibit, which has toured 441 major cities worldwide and educated over 800,000 people on the history to the present day of abusive and racist psychiatric practices, has been displayed at the Congressional Black Caucus Foundation Annual Legislative Conference in Washington, DC, and at other locations.

[1] https://www.cpn.or.kr/journal/view.html?volume=20&number=2&spage=320#B19
[2] https://pubmed.ncbi.nlm.nih.gov/30828744/

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