Mental Health Watchdog calls on FDA to ensure consumers have access to updated information on serious and significant public health concerns of ADHD drugs.

By CCHR International
The Mental Health Industry Watchdog
April 5, 2023

Data obtained by CCHR International from IQVia’s Total Patient Tracker database (formerly IMS health), has uncovered concerning numbers regarding the use of ADHD drugs in the United States. According to the data, 9.5 million Americans have been prescribed ADHD drugs, 3,155,441 of them are children and teens, and of those 58,091 are aged 0-5 years old. Driven by the widespread diagnosis of ADHD, the pharmaceutical market continues to grow, while much of the public remains unaware of the documented ADHD drug risks.

The industry behind ADHD drugs thrives on the fact that an ADHD diagnosis is based solely on behavior, as no medical tests confirm ADHD to be a biological condition requiring treatment. This fact was openly acknowledged by the National Institute of Health Consensus Conference concerning ADHD in their final statement, “We do not have an independent, valid test for ADHD, and there are no data to indicate ADHD is due to a brain malfunction.”[1]

Numerous studies have shown that the use of ADHD drugs can lead to a variety of health issues, including seizure or irregular heartbeat, abuse or addiction, depression, anxiety, hostility, sleep problems, decreased appetite, delayed growth, hallucinations, and more.

One particular concern is the potential for drug dependence and addiction. The U.S Drug Enforcement Administration (DEA) places ADHD drugs in the same class of highly addictive drugs as OxyContin and fentanyl. The DEA also warns ADHD drugs can lead to “severe psychological dependence.”[2]

The FDA created Medication Guides (MedGuides) to ensure consumers have access to accurate information in an easy-to-understand format, about any prescription drugs that merit a “serious and significant public health concern.” Despite the potential of MedGuides to support consumers’ healthcare decisions, their online usage and functionality are hindered by both a lack of public awareness that they exist and technical limitations when trying to use them on mobile devices. The agency must prioritize both issues if it wishes to provide the public with vital information about prescription drug risks.

Like the DEA, the FDA’s MedGuides warn that ADHD drugs can lead to physical dependence and withdrawal reactions among other side effects. They also warn that many brand-name ADHD drugs may put users at risk for a variety of concerning side effects.

For example, the MedGuides cite the following risks with the majority of brand-name ADHD drugs[3]:

• new or worse behavior and thought problems
• new or worse aggressive behavior or hostility
• sudden death in patients who have heart problems or heart defects
• stroke and heart attack in adults
• increased blood pressure and heart rate

Some Med Guides for ADHD drugs also include this warning[4]:

• new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

To safeguard the public’s well-being, having access to accurate information about prescription drug risks is paramount. It is essential that the FDA widely promotes the online MedGuides so anyone can avail themselves of the information in order to make informed decisions.

Additionally, the FDA must improve the functionality of the MedGuides on mobile platforms.

CCHR urges consumers to contact the FDA to demand that the MedGuides be made fully functional on mobile devices at 1-888-INFO-FDA or 1-888-463-6332.

No one should attempt to stop taking these drugs without a doctor’s supervision.

[1] “Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder,” National Institutes of Health Consensus Development Conference Statement, November 16-18, 1998

[2] “Methylphenidate (A Background Paper),” Drug Enforcement Administration, 1995, https://www.ojp.gov/ncjrs/virtual-library/abstracts/methylphenidate-background-paper

[3] https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021121s044lbl.pdf#page=30; 
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15; 
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/010187s093lbl.pdf#page=13; 
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021259s025lbl.pdf#page=16

[4] https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15; 
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/010187s093lbl.pdf#page=13