Children's Health & Safety Association

Issue 43: July 2018

Sunday, 30 June 2013 11:31

17 Deaths Reported in Second-Generation Antipsychotic Drugs for Children Feature Story

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May 13, 2013 – There is a very serious and disturbing, growing trend taking place in Canada. Children as young as preschoolers are being prescribed antipsychotic drugs, once reserved for schizophrenia and mania in adults, to treat Attention Deficit/Hyperactivity Disorder (ADHD), conduct and mood disorders, aggression and other behavioural problems. As of December 31, 2012, Health Canada received 17 fatality reports and 73 reports of 'cardio-metabolic' reactions in children causing dramatic weight gain, high blood pressure, and blood sugar abnormalities.

Health Canada received 17 fatality reports and 73 reports of 'cardio-metabolic' reactions in children causing dramatic weight gain, high blood pressure, and blood sugar abnormalities.  

Dr. David Juurlink, a specialist in internal medicine and head of clinical pharmacology and toxicology at Toronto’s Sunnybrook Health Sciences Centre stated that Second-Generation Antipsychotic Drug) SGA's, can cause a range of neurological side effects within hours or days of starting treatment, including acute dystonia, (sudden, involuntary spasms) as well as a 30-fold higher risk of 'metabolic syndrome', a cluster of conditions that increase the risk of heart disease and stroke. "Another side effect called antipsychotic-induced akathisia, (Greek “not to sit”) can cause extreme restlessness and fidgeting, rocking while sitting or standing or marching on the spot. The side effect is sometimes mistaken as a symptom of the underlying condition," said Dr. Juurlink.

drug2Aripiprazole, otherwise known as Abilify, is the only drug that is officially approved for use in children and then only for the treatment of schizophrenia in teenagers 15 to 17 years of age. Previously, there were no authorized indications for the use of second-generation antipsychotics (SGA) in children or adolescents under 18 years of age in Canada. The vast majority of SGA's have not been tested and approved for children nor are the side effects fully known.

It is important to note that the drugs in the reports are only listed as playing a 'suspect' role and do not prove cause and effect, taking into account most of the children were on multiple medications, and some died from suicide, cardiomyopathy (inflammation of the heart muscle), and long QT syndrome, a genetic abnormality that can cause sudden death.

“The big issue is, are the medications (antipsychotics) that are being prescribed used in the right way or not? That’s a huge question,” says Dr. Stanley Kutcher, Sun Life Financial chair in adolescent mental health at Dalhousie University in Halifax. “And the answer is, we don’t know, because the studies haven’t been done.”

drug3Dr. Dina Panagiotopoulos, an associate professor in the department of paediatrics at the University of British Columbia and an endocrinologist at BC Children's Hospital stated she has seen several children who developed diabetic ketoacidosis, a potentially life-threatening condition caused by a sudden rise in blood sugar and a severe lack of insulin, after starting an SGA drug, which if left untreated, can lead to coma and death. "The reports of cardio-metabolic reactions are the tip of the iceberg. There is significant under reporting to Health Canada. Doctors have become so used to seeing them they're going unreported," said Dr. Panagiotopoulos.

"The reports of cardio-metabolic reactions are the tip of the iceberg.  There is significant under reporting to Health Canada.  Doctors have become so used to seeing them they're going unreported."    

Dr. Dina Panagiotopoulos,
Associate Professor, Dept. of
Paediatrics at University of BC &
Endocrinologist at BC Children's
Hospital - May 2013

A study completed by Rebecca Ronsley, David Scott, William P. Warburton, Ramsay D. Hamdi, Dianna Clare Louie, Jana Davidson, and Dr. Constadina Panagiotopoulos in British Columbia was recently published in the Canadian Journal of Psychiatry wherein they reported a high increase of SGA's given to boys as young as six years of age between 1996 and 2011. According to the B.C. Health Ministry, the total number of children under 18 who received an antipsychotic prescription increased to 5,791 in 2011 from 1,583 in 1996 – a 365% increase. The total number of youths who specifically received SGA's increased to 5,432 from 315 over the study period – a 1,720% increase.

Only one study tested SGA's in adolescents with symptoms of depression who had bipolar disorder and it showed no improvement in depressive symptoms whatsoever. Regardless of this fact, prescribing SGA's continues. Although once doctors are made aware of the side effects and the monitoring required, "they aren't so keen to prescribe them," said Dr. Panagiotopoulos.

Health Canada relies on manufacturers, distributors, doctors and citizens to submit adverse drug reaction reports, but studies suggest it receives only a fraction of the total side effects experienced by patients outside clinical trials and it can take up to two years for the federal regulator to issue a warning about a specific drug. Before the Conservative government considers legislating a mandatory requirement for doctors to report negative side effects that people experience from prescription drugs, it first wants to examine the effectiveness of its decision by commissioning Accreditation Canada, a non-profit organization to monitor the performance of more than 700 health-care facilities and develop a new standard in reporting negative side effects.

drug4From 2005 to 2009, antipsychotic drug prescriptions for Canadian children and youths rose 114%. In Canada, there are 7 marketed second-generation antipsychotics: clozapine, risperidone, olanzapine, quetiapine, paliperidone, ziprasidone and aripiprazole. The date of marketing ranges from 1991 (clozapine) to 2009 (aripiprazole). The prescribing of drugs is regulated provincially and territorially by various doctors’ licensing bodies and those regulators appear to be doing little to control the ever-widening prescribing of antipsychotics and other psychiatric drugs.

Medical experts highly recommend parents:

  1. Obtain information from your doctor about the specific symptoms the drug is targeting.
  2. Discuss the side effects caused by the drug.
  3. Discuss whether there are other options available before agreeing to place your child on an antipsychotic drug.

When prescribing second-generation antipsychotics, physicians should:

  1. Ensure the appropriate psychiatric diagnosis is made.
  2. Consider target symptoms, approv­ed indications, and degree of functional im­pairment before initiating treatment.
  3. Monitor all patients according to approved protocol.
  4. Encourage preventive lifestyle practices.

CDCP Releases First Report on Mental Disorders in Children

drug5On May 16th, the Center for Disease Control and Prevention (CDCP) completed its first study for mental disorders among children aged 3 to 17 years and reported that 13 to 20% of children in the United States suffer from a mental disorder, but take into account that this percentile includes overlapping and double counting of conditions with children that have more than one disorder.

The study led by Ruth Perou, a developmental psychologist and team leader for child development studies at the CDC, authored the report wherein she stated the number has been rising steadily for more than a decade. Mental disorders affects one in five kids and cost approximately $247 billion dollars per year in medical bills, special education and juvenile justice.

According to the US Department of Health and Human Services - Health Resources and Services Administration; Maternal and Child Health Bureau; Mental health: A report of the Surgeon General Rockville, MD: US Department of Health and Human Services; Substance Abuse and Mental Health Services Administration; Center for Mental Health Services; National Institutes of Health; and National Institute of Mental Health; 1999 report states:

Suicide, which can be hastened by an untreated mental illness, was the leading cause of death (after accidents) among children between the ages of 12 to 17 years in 2010.

"Mental disorders among children are defined as serious deviations from expected cognitive, social, and emotional development" and often have difficulty with learning in school, making friends, and building relationships later in life. They are also more prone to having chronic health problems such as asthma, diabetes and epilepsy, and are at serious risk of developing mental illnesses in their adult life…with decreased productivity, increased substance abuse and injury, and substantial costs to the individual and society."

Medical professionals and researchers agree that more studies are required to determine the specific causes of mental disorders including environmental factors, chemical exposures, and poverty. Recently the CDC reduced its level on lead poisoning from 10 to 5 micrograms per decilitre cutting in half the lead level limit for children from one to five years of age. High lead-levels in young children can affect their cognitive and behavioural development, cause learning disabilities, seizures, and even death in some cases. The effects of lead exposure are greatest in unborn children and those under five years of age.

While there are no standard ways of counting afflictions, the most prevalent mental health diagnoses are:

  • Attention Deficit/Hyperactivity Disorder (ADHD) affects 6.8% of children
  • Behavioural Conduct Problems affects 3.5% of children
  • Anxiety (fears and phobias) affect 3% of children
  • Depression affects 2.1% of children
  • Autism Spectrum Disorder (ASD) affects 1.1% of children
  • Tourette syndrome affects 0.2% of children aged 6 – 17 years
  • Illicit drug disorder affects 4.7% of adolescents aged 12 – 17 years of age (in the past year)
  • Alcohol abuse disorder affects 4.2% of adolescents aged 12 – 17 years of age (in the past year)
  • Cigarette dependence affects 2.8% of adolescents aged 12 – 17 years of age (in the past year)

drug6Suicide, which can be hastened by an untreated mental illness, was the leading cause of death (after accidents) among children between the ages of 12 to 17 years in 2010.

Bipolar disorder, Schizophrenia and eating disorders were not included in the above ratings due to unreliable data. The CDC states:

"Future surveillance of mental disorders among children should include standard case definitions of mental disorders to ensure comparability and reliability of estimates across surveillance systems, better document the prevalence of mental disorders among preschool-age children, and include additional conditions such as specific anxiety disorders and bipolar disorder."

In 2010, mood disorders were among the most common principal diagnoses for all hospital stays among children in the United States.  

Healthcare Cost and Utilization Project, USA

"Standard surveillance case definitions are needed to reliably categorize and count mental disorders among surveillance systems, which will provide a more complete picture of the prevalence of mental disorders among children. More comprehensive surveillance is needed to develop a public health approach that will both help prevent mental disorders and promote mental health among children."

"A second nationally representative study, which used data on principal diagnoses for hospital stays in the United States from the Healthcare Cost and Utilization Project, reported that in 2010, mood disorders were among the most common principal diagnoses for all hospital stays among children in the United States, and the rate of hospital stays among children for mood disorders increased 80% during 1997–2010, from 10 to 17 stays per 10,000 population."

Over-diagnosis of mental disorders in children may be higher in the United States due to the pharmaceutical industry having an increased vested interest and therefore, strong presence within the media.

Ontario Mental Health Child Study is the GLOBAL GOLD STANDARD

drug7The Ontario Mental Health Child Study, co-authored by the late Dr. Dan Offord in 1983, has become the global gold standard for measuring children's mental health and now, after 30 years, is being updated with Hamilton, Ontario experts.

The 1983 study involving 3,294 children aged 4 to 16 years from 1,869 families across Ontario found that one in five children suffer from a form of mental disorder.

The new study in collaboration with Statistics Canada and funded by the Canadian Institute of Health Research, will be lead by Mike Boyle, professor in the department of psychiatry and behavioural neurosciences at McMaster University and member of the Offord Centre for Child Studies (affiliated with McMaster University and Hamilton Health Sciences). The study will include a representative sample of more than 10,000 children aged 4 to 18 years from 7,020 families living in Ontario within 180 neighbourhoods who attend 240 schools throughout the province.

The study will delve into risk factors such as increases in family breakdowns, growth of visible minorities, poverty, depression, anxiety and Attention Deficit/Hyperactivity Disorder (ADHD), and search for links to other health conditions as well as social and academic adversities. Information will be collected from parents, teachers, and older children, as well as administrative records from Ontario service providers. The prime directive of the study will be to determine if mental disorders in children have increased in the last 30 years.

Dr. Dan Offord founded the 'Canadian Centre for Studies of Children at Risk' at McMaster University and is considered one of the world's leading experts on child development.

The Troubled Minds of Children

drug8The developing brain is more vulnerable to chronic stress than most parents realize. Drew McWilliams, a clinician and Chief Operating Officer at Morrison Child and Family Services in Portland, Oregon reports that the constant barrage of stress hormones can change the way the brain develops, causing behavioural and psychological disorders that place children at risk for mental illness later in life.

The American Psychological Association states that 69% of parents believed their stress had little or no impact on their kids, while 91% of children said they witnessed the effects in their parents' tension and arguing which made them feel sad, worried, anxious and frustrated. Since the U.S. financial collapse of 2008, McWilliams said his clinic reported an increasing number of children suffering from anxiety, depression and post-traumatic stress disorder.

Susan Lowery O'Connell, a psychologist who manages an early-childhood mental health program in Stark County, Ohio said, "When you don't have a roof over your head, you're not really worried about emotional literacy…however, if that happens during your children's development, it's really making a mark."

"When you don't have a roof over your head, you're not really worried about emotional literacy…however, if that happens during your children's development, it's really making a mark."    

Susan Lowery O'Connell,
Psychologist for Early Child
Mental Health Program
Stark County, Ohio – May 2013

Experiences and environmental factors such as where we live can alter the way genes behave. These chemical switches that regulate gene expression are influenced through a process called epigenetics. Stress, neglect and abuse can trigger a cascade of signals that cause chemical markers to attach to a gene and while the DNA remains unchanged, the markers can turn a gene on or off causing early-life stress and hormone disruption which is a risk factor for major depression and post-traumatic stress disorder.

"Children dealing with high-stress situations won't just 'get over' stress," says Lowery. "Instead they have to decrease their stress response by performing a cognitive task, like attaching a word to how they feel or focusing their attention elsewhere. These are skills that don't come intuitively, but must be taught by attentive parents and teachers."

Anti-Psychotropic Drug Usage among U.S. Childrendrug9

Children receiving foster care in Ohio are nine times more likely to be given anti-psychotic drugs than children on Medicaid. "Our data tells us that children enrolled in foster care in Ohio tend to have many more psychotropic medications and many more prescriptions generally, than the overall kids enrolled in Medicaid population and certainly kids in Ohio," says Tracy Plouck, Director of the Ohio Department of Mental Health.

BEACON (Best Evidence Advancing Child Health in Ohio Now), a coalition of the Ohio Department of Job and Family Services, Ohio Department of Mental Health and Ohio Department of Health officials have issued guidelines in hopes of reducing anti-psychotic medications to children under the age of six and reducing psychotropic medications used by children under the age of eighteen by July 2014. A team of doctors and child psychiatrists will evaluate if drugs are necessary based on medications already administered, the child's behaviour and past experiences. BEACON has also advised physicians to contact a specialist for the child if more than three medications were prescribed.


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