FDA’s Psychotropic Drug-Risk Medication Guides Need to be Mobile-Accessible So Consumers are Warned of Dangerous Risks

medication guides psych drugs
Apprising oneself of as much information as possible is a protection against potential harm and enables better healthcare decisions by the consumer or parents of children for whom psychotropic drugs have been recommended. – Jan Eastgate, President CCHR International

Consumers need to inform themselves of psychotropic drug risks through the FDA’s Medication Guides, but the FDA must make these mobile-friendly for fast access.

By Jan Eastgate
President, CCHR International
November 11, 2022

Mobile phone access to psychotropic drug risk information is crucial in the United States where over 70 million Americans are prescribed the drugs. Current estimates are that 96% of the population has a cellphone, while individuals with smartphones have risen to 81%. At least 70% of internet access is through mobile phones.[1] This means that information about psychiatric drug risks needs to be easily and quickly accessible to consumers on mobile devices. An overview of the most serious drug risks is available in the Food and Drug Administration’s online Medication Guides (Med Guides) designed to give consumers easy-to-understand information on drug side effects. However, they do not function correctly on mobile phones.

Information on prescription drug risks is vital for consumers to easily access, as psychiatrists and doctors do not always fully inform patients of the documented risks. Attorney James Gottstein reports in the journal Ethical Human Psychology and Psychiatry: “Psychiatrists regularly fail to obtain informed consent by not fully informing their patients of the risks of psychotropic drugs as well as overstating their benefits.”[2] 

CCHR’s co-founder, the late Professor Thomas Szasz, advised, the best protection a mental health treatment consumer can have is to be better informed. The Med Guides should provide this but fail to when they are not geared towards mobile phone usage.

In 2022, the FDA reported that it receives more than 100,000 reports every year that are related to medication errors that can occur in pharmacies, hospitals, and patient homes.[3] This is a further argument as to why the FDA needs to make the Med Guides mobile user-friendly, to enable patients to check for adverse effects as soon as a prescription is recommended—in the doctor’s office.

Med Guides are usually paper handouts that come with many—but not all—prescription medicines. They contain risk information right up front and in language geared toward a patient or consumer, rather than a healthcare professional. 

Medication Guides

Attempting to read the extensive drug packaging information that comes with any medication can be confusing, as evidenced by the more than 500,000 Americans who misinterpret them every year. Annually, there are about 1.5 million preventable medication errors. Roughly one-third of those mistakes occur outside of hospitals, where patients must rely upon their own ability to follow the instructions on their medication containers.[4]

Under the federal Food, Drug, and Cosmetic (FD&C) Act, the FDA requires that Med Guides be dispensed with products the agency deems a serious and significant public health concern. The manufacturer is responsible for ensuring that pharmacists have the Guides in sufficient numbers to provide one to each patient who receives the drug.[5] These are also available on the FDA website.

Med Guides were specifically designed to be easier for the average consumer to read and understand. They must:

  • Use a larger font (no smaller than 10 point)
  • Must be written using “nontechnical, understandable language,” and “shall not be promotional in tone or content”
  • Must describe “the particular serious and significant public health concern that has created the need for the Medication Guide” and must note any known “pediatric risks”
  • Must include “a statement of the risk, if there is one, of the patients developing dependence on the drug product”[6]

This does not supplant the responsibility of a psychiatrist, psychologist, or doctor to fully inform their patients, but this frequently does not occur. According to the legal firm McKeen & Associates, PC, “psychiatrists have an obligation to follow certain procedures associated with patient treatment. For example, they must:

  • Obtain informed consent of the patient or their guardian,
  • Properly test and monitor a patient’s response to medication,
  • Carry out a thorough neurological evaluation of a patient who demonstrates certain symptoms of high concern–such as impaired consciousness or altered mental state, and
  • Terminate the patient using appropriate procedures.”[7]

However, a British Medical Journal article notes, “Psychiatry is a disaster area in healthcare that we need to focus on. With its liberal use of psychiatric drugs, psychiatry—which includes the work of GPs with psychiatric patients—does far more harm than good.”[8]

Part of that involves patients being given misleading information to convince them to take a psychotropic drug, such as an antidepressant. The BMJ further reports that “many psychiatrists still tell their patients that they suffer from a chemical imbalance, and that taking a psychiatric drug is similar to taking insulin for diabetes.”[9] This is patently false and more recently was proven in a Molecular Psychiatry-published study to have been known about for more than 30 years.  Such misinformation constitutes consumer fraud and adds weight to the need for consumers to better inform themselves, minimally through the Med Guides.

Supporting the need for this is a March 2022 article published in the Journal of Mental Health, which revealed that patients are often not given full informed consent before prescribed antipsychotics. John Read, professor of clinical psychology at the University of East London, based his conclusions on an online questionnaire. Of the 2,346 individuals who responded to the survey, 757 were included in Read’s analysis, most hailing from the U.S. (71%).[10] 

More than 11.15 million Americans take antipsychotics, of which 829,372 are ages 0-17. Of the latter, 30,632 are aged 0-5, reinforcing the need for parents to be better informed.[11]

Prof. Read found that “hardly any of the 757 people were told about diabetes, sexual dysfunction, suicidality, potentially shortened life span, neuroleptic malignant syndrome (which is a life-threatening reaction to APs involving rapid onset fever and muscle rigidity), and none were told about withdrawal effects or reduced brain volume….”

The participants were asked such questions as:

  • “Did the prescribing doctor tell you how the antipsychotic medication works?”
  • “Did the doctor inform you of any possible side effects?”
  • “Were you offered any other treatment options to consider as alternatives or additions to antipsychotics?”
  • “When you were first prescribed antipsychotic medication, how long were you told you could expect to take it for?”[12]

A Sample of Medication Guide Information

Med Guides draw attention to serious risks, which the FDA often issues as a “black box” warning—its most serious.

The guides for SSRI antidepressants immediately inform the patient of the risk of suicide in certain age groups taking the drugs. This information is prominently placed at the top of the guide. The sample of the drugs below provides just some of the information imparted in Med Guides. 

  • Zoloft (sertraline), antidepressant: ZOLOFT and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Serotonin Syndrome: This condition can be life-threatening and symptoms may include: agitation, hallucinations, coma, or other changes in mental status; nausea, vomiting, or diarrhea; racing heartbeat, high or low blood pressure; sweating or fever; coordination problems or muscle twitching (overactive reflexes); muscle rigidity. Manic episodes – Symptoms may include: greatly increased energy; severe trouble sleeping; excessive happiness or irritability; racing thoughts; reckless behavior; talking more or faster than usual; unusually grand ideas. Sexual problems (dysfunction): Taking serotonin and norepinephrine reuptake inhibitors (SSRIs), including ZOLOFT, may cause sexual problems.[13]
  • Abilify (aripiprazole), antipsychotic: ABILIFY can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ABILIFY is not approved for the treatment of patients with dementia-related psychosis. ABILIFY may cause serious side effects, including stroke in elderly people (cerebrovascular problems) that can lead to death; Neuroleptic Malignant Syndrome [potentially fatal]; uncontrolled body movements (tardive dyskinesia); unusual urges – some people taking ABILIFY have had unusual urges, such as gambling, binge eating or eating that you cannot control (compulsive), compulsive shopping and sexual urges; seizures (convulsions); weight gain; risk of suicidal thoughts or actions.[14]
  • Concerta (methylphenidate), ADHD stimulant: BLACK BOX WARNING. CONCERTA is a federally controlled substance because it can be abused or lead to dependence. The following have been reported with use of methylphenidate medicines: Heart-related problems—sudden death in patients who have heart problems or heart defects; stroke and heart attack in adults; increased blood pressure and heart rate. Mental (psychiatric) problems – All Patients: new or worse behavior and thought problems; new or worse aggressive behavior or hostility. Children and Teenagers: new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms. Other serious side effects include slowing of growth (height and weight) in children; seizures, mainly in patients with a history of seizures; eyesight changes or blurred vision.[15]
  • Xanax (alprazolam), sedative hypnotic, tranquilizer, benzodiazepine: BLACK BOX WARNING—XANAX is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Risk of abuse, misuse, and addiction…[XANAX] can lead to overdose and serious side effects including coma and death. Physical dependence and withdrawal reactions. XANAX can cause physical dependence and withdrawal reactions. Do not suddenly stop taking XANAX. Stopping XANAX suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. XANAX may cause serious side effects, including seizures—stopping XANAX can cause seizures and seizures that will not stop (status epilepticus). Mania. XANAX may cause an increase in activity and talking (hypomania and mania) in people who have depression. XANAX can make you sleepy or dizzy and can slow your thinking and motor skills.[16]
Medication Guides

Apprising oneself of as much information as possible is a protection against potential harm and enables better healthcare decisions by the consumer or parents of children for whom psychotropic drugs have been recommended. The guides may also prompt a person to do additional research. For example, if a person stops taking antidepressants or skips a dose or two, a sensation sometimes known as “brain zaps” occurs. This is mentioned in the Med Guides.

Additional information reveals that brain zaps feel like “an electrical sensation in the brain.” One study published in 2022 in “The Primary Care Companion for CNS Disorders” reported how researchers gathered data from questionnaires completed by 2,346 participants who shared their experiences with taking antidepressants and found that 42.5% of the individuals had experienced brain zaps.[17]

Antidepressant withdrawal symptoms, in general, are quite common. According to an article published in 2019 in the journal Addictive Behaviors, as many as half of the people taking antidepressants will have some withdrawal symptoms when they stop taking them or lower the dose.[18]

Studies like this can be found by searching CCHR’s psychiatric drugs side effects searchable database. Anyone suffering an adverse effect of a psychotropic or other prescribed drug can also report it directly to the FDA’s MedWatch adverse drug reaction service.

Consumers should contact the FDA to demand that the Med Guides be fully functional on mobile devices at 1-888-INFO-FDA or 1-888-463-6332.

If a psychiatrist or other mental healthcare professional failed to fully inform you of the treatment they recommended to you and you were harmed, you can report this to CCHR.

[1] https://tynmagazine.com/what-percentage-of-internet-traffic-is-mobile/; https://www.ciodive.com/news/70-of-internet-traffic-comes-from-mobile-phones/510120/

[2] James B. Gottstein, “Psychiatrists’ Failure to Inform: Is There Substantial Financial Exposure?” Ethical Human Psychology and Psychiatry; New York, Vol. 9, Iss. 2, (2007): 117-125, https://www.proquest.com/docview/205070933

[3] https://www.singlecare.com/blog/news/medication-errors-statistics/

[4] https://www.consumerreports.org/cro/2011/06/can-you-read-this-drug-label/index.htm

[5] http://www.ncbop.org/faqs/pharmacist/faq_medicationguidelines.htm

[6] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=208.20

[7] https://www.mckeenassociates.com/blog/2019/01/5-types-of-psychiatrist-negligence-that-can-lead-to-a-lawsuit/

[8] “What are your burning issues for 2018?” BMJ 4 Jan. 2018, https://www.bmj.com/content/360/bmj.k9/rr-15

[9] “What are your burning issues for 2018?” BMJ 4 Jan. 2018, https://www.bmj.com/content/360/bmj.k9/rr-15

[10] Read, J., “How important are informed consent, informed choice, and patient-doctor relationships when prescribing antipsychotic medication?” Journal of Mental Health, (2022), https://repository.uel.ac.uk/item/8q5xx; https://www.madinamerica.com/2022/03/antipsychotics-often-prescribed-without-informed-consent/

[11] https://www.cchrint.org/psychiatric-drugs/people-taking-psychiatric-drugs/

[12] Read, J., “How important are informed consent, informed choice, and patient-doctor relationships when prescribing antipsychotic medication?” Journal of Mental Health, (2022), https://repository.uel.ac.uk/item/8q5xx; https://www.madinamerica.com/2022/03/antipsychotics-often-prescribed-without-informed-consent/

[13] Zoloft Medication Guide, U.S. Food and Drug Administration, https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019839s100,020990s057lbl.pdf#page=27

[14] Abilify Medication Guide, U.S. Food and Drug Administration, https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021436s044s045,021713s035s036,021729s027s028,021866s029s030lbl.pdf#page=77

[15] Concerta Medication Guide, U.S. Food and Drug Administration, https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021121s044lbl.pdf#page=30

[16] Xanax Medication Guide, U.S. Food and Drug Administration, https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018276s058lbl.pdf#page=27

[17] https://www.health.com/condition/depression/brain-zaps

[18] https://www.health.com/condition/depression/brain-zaps