Antipsychotics for Children With ADHD Should Be a Last Resort

Jeannette Y. Wick
pharmacytimes.com
Originally published 20 Feb 20

Here is an excerpt:

ANTIPSYCHOTICS: NOT FIRST LINE

A freestanding diagnosis of ADHD is not an indication for antipsychotic medications. Although no studies have determined which children who get an ADHD diagnosis are most likely to receive antipsychotic medications, mental health comorbidity is a possible factor.

ADHD often occurs in conjunction with other mental health conditions. Common comorbidities include conduct disorder (depression, or oppositional defiant disorder), and prescribers may use antipsychotic drugs to augment other approaches. The evidence does not support using antipsychotic medication for depression in youths, but some data support a risperidone trial for conduct disorder or oppositional defiant disorder in stimulant-resistant youths with ADHD.

A second concern is aggression. Aggression that stems from poor impulse control is common in youths who have ADHD, and it frequently occurs in children who have comorbidities. This behavior is often associated with a need for assessment, hospitalization, or urgent care and requires careful follow-up and cautious risk assessment. ADHD may not respond to stimulant medications, so prescribers may use antipsychotic drugs off-label in an effort to reduce aggressive outbursts. Research shows that antipsychotic-treated youths with ADHD often have clinical characteristics associated with aggression. However, few youths with ADHD who were treated with antipsychotics received the evidence-indicated trial doses of 2 stimulants before an antipsychotic.

The info is here.

Study questions why thousands with developmental disabilities are prescribed antipsychotics

Peter Goffin
The Toronto Star
Originally published August 23, 2017

Researchers with the Centre for Addiction and Mental Health and the Institute for Clinical Evaluative Sciences have called for “guidelines and training around antipsychotic prescribing and monitoring” for doctors, pharmacists and care home staff after finding that nearly 40 per cent of people with developmental disabilities were prescribed antipsychotic drugs at some point over a six-year period.

One-third of the patients prescribed antipsychotics had no documented diagnosis of mental illness, according to the study, which tracked more than 51,000 people with developmental disabilities who are eligible for provincial drug benefits.

“We don’t know, with the data, why this one person was prescribed or this (other) person was prescribed so we’re trying to almost guess at why,” said psychologist Yona Lunsky, lead author of the study.

“It could be behaviour, aggression, self-injury, agitation.”

For people with developmental disabilities who live in group homes, the rate of antipsychotic prescriptions was even higher.

About 56 percent of developmentally disabled group home residents were prescribed antipsychotics. Of those, around 43 percent had no documented mental health issues.

The article is here.

Restrict the Recruitment of Involuntarily Committed Patients for Psychiatric Research

Carl Elliott and Matt Lamkin
JAMA Psychiatry
Published online February 10, 2016. doi:10.1001/jamapsychiatry.2015.3117

Can an involuntarily committed psychiatric patient give truly voluntary consent for medical research? This question has been fiercely debated in Minnesota since 2008, when the St Paul Pioneer Press reported the death of Dan Markingson, a mentally ill young man who had been recruited into an antipsychotic study at the University of Minnesota while under a civil commitment order. Along with many others, we have argued that the circumstances of Markingson’s commitment order compromised the voluntariness of his consent to the study. Although federal guidelines are silent on the issue, we believe the Markingson case serves as a powerful argument for serious restrictions on the recruitment of involuntarily committed patients into psychiatric research studies.

The article is here.

Antipsychotics, Other Psychotropics, and the Risk of Death in Patients With Dementia

Maust DT, Kim H, Seyfried LS, et al.
Antipsychotics, Other Psychotropics, and the Risk of Death in Patients With Dementia: Number Needed to Harm.
JAMA Psychiatry. Published online March 18, 2015.
doi:10.1001/jamapsychiatry.2014.3018.


Importance

Antipsychotic medications are associated with increased mortality in older adults with dementia, yet their absolute effect on risk relative to no treatment or an alternative psychotropic is unclear.

Objective

To determine the absolute mortality risk increase and number needed to harm (NNH) (ie, number of patients who receive treatment that would be associated with 1 death) of antipsychotic, valproic acid and its derivatives, and antidepressant use in patients with dementia relative to either no treatment or antidepressant treatment.

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Conclusions and Relevance

The absolute effect of antipsychotics on mortality in elderly patients with dementia may be higher than previously reported and increases with dose.

The research article is here.

UMN research review finds inadequate protections

By Josh Verges
twincities.com
Originally posted February 27m 2015

A decade after a psychiatric patient's suicide, the University of Minnesota still fails on several fronts to protect vulnerable human research subjects.

That's the finding of an external review ordered by President Eric Kaler last year and made public Friday. It raises serious questions about the authorization of and oversight for U research, especially in the Department of Psychiatry.

Questions about recruitment, consent and treatment have persisted since a 2008 Pioneer Press series concerning the 2004 death of Dan Markingson, an antipsychotic drug research subject.

The entire article is here.

Johnson & Johnson to pay over $2 billion to settle Risperdal investigations

By Joe Carlson
Modern Healthcare
Posted: November 4, 2013

In the largest-ever legal settlement for sales of a single drug, Johnson & Johnson has agreed to pay more than $2 billion and plead guilty to a misdemeanor charge of misbranding to end long-running investigations of its sales tactics involving Risperdal.

The New Brunswick, N.J.-based company and subsidiaries Janssen Pharmaceuticals and Scios told investors in August 2011 that they had agreed to settle allegations that J&J promoted its anti-psychotic Risperdal for off-label uses. On Thursday, company officials are scheduled to plead guilty in federal court.

The entire story is here.

APA releases guidelines on cutting antipsychotic overuse

By  Brie Zeltner
The Cleveland Plain Dealer
Originally published on September 20, 2013

Doctors and patients should question of the use of antipsychotic medications in patients, particularly among the elderly with dementia and children and adolescents without psychotic disorders.

That’s according to a list of five common uses of the medications that are potentially unnecessary and could cause harm released today by the American Psychiatric Association as part of a national effort called the Choosing Wisely campaign.

The entire article is here.

Antipsychotics: Taking the Long View

By Thomas Insel
NIMH Director's Blog
Originally published on August 28, 2013

Here is an excerpt:

An article recently posted online in JAMA-Psychiatry tells an interesting story about medications and recovery.1 Wunderink and colleagues from the Netherlands report on a seven-year follow-up of 103 people with schizophrenia and related disorders who had experienced a first episode of psychosis between 2001 and 2002. After six months of symptomatic remission following antipsychotic treatment, patients were randomly assigned to either maintenance antipsychotic treatment or a tapering-off and discontinuation of the drug. As expected, the group that stopped taking their medications experienced twice the relapse rates in the early phase of the follow-up. But these rates evened out after a few years, as some patients in the maintenance group also stopped taking their medication. Most important, by seven years, the discontinuation group had achieved twice the functional recovery rate: 40.4 percent vs. only 17.6 percent among the medication maintenance group. To be clear, this study started with patients in remission and only 17 of the 103 patients—21 percent of the discontinuation group and 11 percent of the maintenance group—were off medication entirely during the last two years of follow-up. An equal number were taking very low doses of medication—meaning that roughly one-third of all study patients were eventually taking little or no medication.

Emphasis added.

The entire blog post is here.

Thanks to Tom Fink for this story.

The Psychiatric Drug Crisis

BY GARY GREENBERG

The New Yorker

Originally posted on September 3, 2013

It’s been just over twenty-five years since Prozac came to market, and more than twenty per cent of Americans now regularly take mind-altering drugs prescribed by their doctors. Almost as familiar as brands like Zoloft and Lexapro is the worry about what it means that the daily routine in many households, for parents and children alike, includes a dose of medications that are poorly understood and whose long-term effects on the body are unknown. Despite our ambivalence, sales of psychiatric drugs amounted to more than seventy billion dollars in 2010. They have become yet another commodity that consumers have learned to live with or even enjoy, like S.U.V.s or Cheetos.

Yet the psychiatric-drug industry is in trouble. “We are facing a crisis,” the Cornell psychiatrist and New York Times contributor Richard Friedman warned last week. In the past few years, one pharmaceutical giant after another—GlaxoSmithKline, AstraZeneca, Novartis, Pfizer, Merck, Sanofi—has shrunk or shuttered its neuroscience research facilities. Clinical trials have been halted, lines of research abandoned, and the new drug pipeline has been allowed to run dry.

The entire story is here.

Thanks to Tom Fink for this story.

U.S. Nursing Homes Reducing Use of Antipsychotic Drugs

By Alan Mozes
MedicineNet.com
Originally published August 27, 2013

A year-old nationwide effort to prevent the unnecessary use of antipsychotic medications in U.S. nursing homes already seems to be working, public health officials report, as facilities begin to opt for patient-centered approaches over drugs to treat dementia and other related complications.

So far, the program has seen more than a 9 percent drop in the national use of antipsychotics among long-term nursing-home residents, when comparing the period of January to March 2013 with October to December 2011.

The entire story is here.

A Dry Pipeline for Psychiatric Drugs

By RICHARD A. FRIEDMAN, M.D.
The New York Times
Published: August 19, 2013

Fully 1 in 5 Americans take at least one psychiatric medication. Yet when it comes to mental health, we are facing a crisis in drug innovation.

Sure, we have many antidepressants, antipsychotics, hypnotic medications and the like. But their popularity masks two serious problems.

First, each of these drug classes is filled with “me too” drugs, which are essentially just copies of one another; we have six S.S.R.I. antidepressants that essentially do the same thing, and likewise for the 10 new atypical antipsychotic drugs.

Second, the available drugs leave a lot to be desired: patients with illnesses like schizophrenia, major depression and bipolar disorder often fail to respond adequately to these medications or cannot tolerate their side effects.

The entire story is here.

U.S. Probes Use of Antipsychotic Drugs on Children

By LUCETTE LAGNADO
The Wall Street Journal
Originally published August 12, 2013

Federal health officials have launched a probe into the use of antipsychotic drugs on children in the Medicaid system, amid concern that the medications are being prescribed too often to treat behavioral problems in the very young.

The inspector general's office at Department of Health and Human Services says it recently began a review of antipsychotic-drug use by Medicaid recipients age 17 and under. And various agencies within HHS are requiring officials in all 50 states to tighten oversight of prescriptions for such drugs to Medicaid-eligible young people.

The effort applies to a newer class of antipsychotic drugs known as "atypicals," which include Abilify, the nation's No. 1 prescription drug by sales. The drugs were originally developed to treat psychoses such as schizophrenia, but some now have Food and Drug Administration approval for treatment of children with conditions such as bipolar disorder and irritability associated with autism.

The entire story is here.

Medicare Drug Program Fails to Monitor Prescribers, Putting Seniors and Disabled at Risk

by Tracy Weber, Charles Ornstein and Jennifer LaFleur
ProPublica
Published: May 11, 2013

Ten years ago, a sharply divided Congress decided to pour billions of dollars into subsidizing the purchase of drugs by elderly and disabled Americans.

The initiative, the biggest expansion of Medicare since its creation in 1965, proved wildly popular. It now serves more than 35 million people, delivering critical medicines to patients who might otherwise be unable to afford them. Its price tag is far lower than expected.

But an investigation by ProPublica has found the program, in its drive to get drugs into patients' hands, has failed to properly monitor safety. An analysis of four years of Medicare prescription records shows that some doctors and other health professionals across the country prescribe large quantities of drugs that are potentially harmful, disorienting or addictive. Federal officials have done little to detect or deter these hazardous prescribing patterns.

The entire story is here.

Do Antipsychotics Worsen Long-term Schizophrenia Outcomes?

By Robert Whitaker
Mad in America Blog
Originally published March 26, 2013

Martin Harrow and Thomas Jobe have a new article coming out in Schizophrenia Bulletin that I wish would be read by everyone in our society with an interest in mental health. Harrow and Jobe, who conducted the best study of long-term schizophrenia outcomes that has ever been done, do not present new data in this article, but rather discuss the central question raised by their research: Does long-term treatment of schizophrenia with antipsychotic medications facilitate recovery? Or does it hinder it?

This is a paper that needs to be widely known. I wish every psychiatrist in the country would read it, and I wish that it would be widely discussed in the media too.

Now, Harrow’s study produced findings that belied common wisdom. He and Jobe followed schizophrenia patients for 20 years, and those who got off antipsychotics, as a group, had much better outcomes. Over the long term, they were much more likely to be recovered, much more likely to work; they were much less likely to be experiencing psychotic symptoms; and they had better cognitive function and they were much less anxious. So how can you square that finding with research showing that when patients are withdrawn from antipsychotic medications, they relapse at a much higher rate? That is the evidence for long-term use of antipsychotics, and here is what Harrow and Jobe write: “We view the results from these discontinuation studies as involving a paradox.”

Within six to 10 months following discontinuation, they write, 25% to 55% of schizophrenia patients withdrawn from their medications relapse. But, they note, “relapse rates are considerably lower subsequently in discontinued schizophrenia patients who remain stable during these 6-10 months,” and that “patients with schizophrenia not on antipsychotics for a prolonged period do not show this tendency to relapse when they remain unmedicated.”

So the puzzle is this: Why is there such a high relapse rate in the immediate months following withdrawal, compared to the relapse rate when patients “remain unmedicated” after this initial discontinuation period?

The entire blog post is here.

Antipsychotic Use Skyrockets in America's Poorest Children

By Fran Lowry
Medscape Today News
Originally published March 12, 2013

Antipsychotic use among Medicaid-insured children from low- or very-low-income families skyrocketed in just under a decade, new research shows.

Investigators from the University of Maryland in Baltimore found that from 1997 to 2006, use of antipsychotic medications in this population increased 7- to 12-fold, with most of the increased use associated with treatment for behavioral problems.

"Awareness of the expanding use of antipsychotic medications in the emotional and behavioral treatment of children has been noted in several studies of community-based pediatric populations," lead author Julie Magno Zito, PhD, from the University of Maryland, told Medscape Medical News.

"But," she added, "additional information is needed on trends in our neediest youth, namely according to how antipsychotic users differ in terms of their eligibility for Medicaid insurance coverage and the reasons for use. Such information would help to characterize the 'who' and 'why' of expanded antipsychotic use."

The study is published in the March issue of Psychiatric Services.

The entire article is here.

Four Common Antipsychotic Drugs Found to Lack Safety and Effectiveness in Older Adults

Science Daily
Originally published November 27, 2012

In older adults, antipsychotic drugs are commonly prescribed off-label for a number of disorders outside of their Food and Drug Administration (FDA)-approved indications -- schizophrenia and bipolar disorder. The largest number of antipsychotic prescriptions in older adults is for behavioral disturbances associated with dementia, some of which carry FDA warnings on prescription information for these drugs.

In a new study -- led by researchers at the University of California, San Diego School of Medicine, Stanford University and the University of Iowa, and funded by the National Institute of Mental Health -- four of the antipsychotics most commonly prescribed off label for use in patients over 40 were found to lack both safety and effectiveness. The results will be published November 27 in The Journal of Clinical Psychiatry.

The study looked at four atypical antipsychotics (AAPs) -- aripiprazole (Abilify), olanzapine (Zyprexa), quetiapine (Seroquel), and risperidone (Risperdal) -- in 332 patients over the age of 40 diagnosed with psychosis associated with schizophrenia, mood disorders, PTSD, or dementia.

"Our study suggests that off-label use of these drugs in older people should be short-term, and undertaken with caution," said Dilip V. Jeste, MD, Estelle and Edgar Levi Chair in Aging, Distinguished Professor of Psychiatry and Neurosciences, and director of the Stein Institute for Research on Aging at UC San Diego.

The entire story is here.

Thanks to Tom Fink for this information.

A Recent Study of Atypical Neuroleptics: “The Results of our Study are Sobering”

Sandra Steingard, M.D.
Mad In America
Originally published December 3, 2012


This week, MIA highlighted a recently published study of the four most commonly prescribed neuroleptics.  As noted in the post, the major outcome was that these drugs were not found to be effective or safe.

This important study, co-authored by Dilip Jeste the current president of the American Psychiatric Association, is worth reviewing in greater detail.

The study was modeled to capture clinical practice.  Entry to the study was broad and not limited to a specific diagnostic category.  It is characterized as a study of “older adults” and I admit to some chagrin that this meant anyone over 40.  Diagnoses included schizophrenia, schizoaffective disorder,  and psychosis associated with mood disorder, PTSD or dementia.  It was open to individuals who were either already taking an atypical neuroleptic or had a psychiatrist who was recommending this.

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What was most striking to me is this line from the study: there was

“no significant change in psychopathology with any of the study atypical antipsychotics“

They did not even report the numbers in their report.

The entire information is here.

Thanks to Tom Fink for this information.

A Dangerous Remedy (2 Letters)

Two Letters to the Editor from the New York Times published on October 1, 2012.

One is important to understand how psychotropics are currently being used on a daily basis and the second to underscore how psychological treatments are overlooked.

To the Editor:

Re “A Call for Caution on Antipsychotic Drugs,” (Mind, Sept. 25): “A call for caution” is indeed needed and long overdue to curb the inappropriate overuse of antipsychotics. As the author notes, the use of these highly potent and expensive drugs is drastically out of proportion to the appropriate target population: individuals with schizophrenia and bipolar disorder.

The misuse of antipsychotics in nursing homes in particular is a widespread yet preventable problem. Approximately one in four residents are given antipsychotics. The percentage of residents with dementia on these drugs is even higher. Too often, they are used as a form of chemical restraint, as a substitute for good care and adequate staffing. Contrary to what the article states, they are harmful for elderly people with dementia, greatly increasing the risk of stroke, heart attack, falls and even death.

Federal standards have long prohibited the inappropriate use of antipsychotics in nursing homes. With increased public knowledge and vigorous enforcement, hopefully we can make those standards a reality for vulnerable residents.

Richard Mollot

Manhattan

To the Editor:

There was no mention in Dr. Richard A. Friedman’s article about the proven effectiveness of psychological treatment, such as cognitive behavioral therapy, for nonpsychotic disorders. Instead, Dr. Friedman suggests that patients suffering from anxiety or depression take other, less powerful medications. By not recommending psychotherapy for the treatment of anxiety and depression, Dr. Friedman is perpetuating the mind-set that all psychiatric disorders should be treated with medicine, which in effect has created a climate that encourages the off-label use of antipsychotics.

Patricia Thornton

Manhattan

These can be found here.

More U.S. Kids Prescribed Off-Label Antipsychotics: Study

By Mary Elizabeth Dallas

MedicineNet.com

Originally published on September 18, 2012

Over the past decade, off-label use of antipsychotic drugs has increased among children enrolled in Medicaid, according to a new study representing 35 percent of children in the United States.

Off-label drug use is a term used to describe when drugs are prescribed using a dosage, type of dosage or for a purpose that hasn't yet been approved by the U.S. Food and Drug Administration.

In the study, researchers from the Children's Hospital of Philadelphia found a 62 percent jump in the number of publicly insured children between the ages of 3 and 18 taking antipsychotics. In 2007 alone, 65 percent of the 354,000 children on these drugs were taking them for uses that have not been approved by the FDA, the investigators pointed out.

"We knew that the number of children prescribed antipsychotics had grown steadily over the past two decades, particularly among children with public insurance," study author Meredith Matone, a researcher at PolicyLab, said in a hospital news release. "With this study, we wanted to learn more about why these drugs are being used so often, what diagnoses they're being used to treat, and how prescribing patterns changed over the course of the last decade."

Theentire article is here.

J&J Settles Lawsuit Alleging Injury From Antipsychotic

By Peter Loftus

The Wall Street Journal

Originally published September 10, 2012

Johnson and Johnson agreed to a last-minute settlement of a lawsuit claiming that a boy's use of its antipsychotic drug Risperdal caused abnormal breast growth.

The settlement—whose terms were confidential—averted a civil trial scheduled to begin Monday in which plaintiffs' lawyers intended to summon J&J Chief Executive Alex Gorsky as a witness. Mr. Gorsky previously held leadership roles at the J&J division responsible for marketing Risperdal during the period when the boy's alleged injury occurred.

Robert C. Hilliard, an attorney for the plaintiff, told a judge in the Philadelphia Court of Common Pleas Monday "this case has reached a final resolution." He said the settlement amount was confidential.

The entire story is here.