Still in the Crib, Yet Being Given Antipsychotics

December 12, 2015

Andrew Rios began having seizures when he was 5 months old, and only got worse. At 18 months, his epilepsy medication was causing severe aggression, so he was prescribed Risperdal, an antipsychotic medication typically used to treat schizophrenia and bipolar disorder in adults.

Andrew began screaming in his sleep and seemed to interact with people and objects that were not there. His frightened mother researched Risperdal and discovered that the drug was not approved, and had never even been studied, in children anywhere near as young as Andrew.

“It was just ‘Take this, no big deal,’ like they were Tic Tacs,”  Genesis Rios, a mother of five in Rancho Dominguez, Calif told New York Times Reporter Alan Schwarz. “He was just a baby.”

It used to be a rare thing that children received off-label prescriptions for psychiatric medications, according to Dr. Judy Illes, co-lead of NeuroDevNet's Neuroethics Core. But Andrew's story is emblematic of a ten-year trend repeatedly documented by Illes and colleague Dr. Nina Di Pietro. The New York Times article chronicling Andrew's experience points to the rapid rise in antipsychotic prescriptions given to children two years of age - or younger - "to control alarmingly violent or withdrawn behaviour."

"This is happening despite the lack of strong evidence for efficacy, and serious adverse effects," said Dr. Illes.

Practice inconsistent with evidence and policy
In Canada, prescriptions for non-psychotic conditions including ADHD, disruptive behaviour and non-specific mood problems are considered off-label and not approved by Health Canada.

Yet prescription continues to escalate, without regard for this constraint, or reported safety concerns in children and youth, including weight gain, diabetes, development of breast tissue in boys, and abnormal movements such as tardive dyskinesia (repeated protrusion of the tongue).

In September, 2013, Illes added, the American Psychiatric Association published a list of best practices for prescribing antipsychotic drugs as part of an intiative called "Choosing Wisely". "The APA's best practices apply to both children and adults," she said, "and emphasizes the importance of initial evaluation and ongoing monitoring as well as careful selection of first-line interventions and adherence to evidence-based practice." 

According to the New York Times, "almost 20,000 prescriptions for risperidone (commonly known as Risperdal), quetiapine (Seroquel) and other antipsychotic medications were written in 2014 for children 2 and younger - a 50 percent jump from 13,000 just one year before, according to the prescription data company IMS Health. Prescriptions for the antidepressant fluoxetine (Prozac) rose 23 percent in one year for that age group, to about 83,000."

The company did not record how many children received these prescriptions or the conditions for which they were prescribed. 

Clinicians struggling to do their best 
In interviews with the Times, "a dozen experts in child psychiatry and neurology said that they had never heard of a child younger than 3 receiving such medication, and struggled to explain it. They presumed that parents and doctors, probably desperate and well meaning, were trying to alleviate thrashing temper tantrums — the kind that get children kicked out of day care — or an overly depressed disposition, like being strikingly inhibited, nonverbal or lethargic.

"People are doing their very best with the tools available to them,” the Times quotes Dr. Mary Margaret Gleason, a pediatrician and child psychiatrist at Tulane University School of Medicine. “There’s a sense of desperation with families of children who are suffering, and the tool that most providers have is the prescription pad."

But Dr. Gleason told the Times that children with ages measured in months had brains whose neurological inner workings were developing too rapidly, and in still unknown ways, to risk using medications that can profoundly influence that growth. She said the medications had never been subject to formal clinical trials in infants and toddlers largely because of those dangers.

“There are not studies,” Dr. Gleason said, “and I’m not pushing for them.”

"The increase in the number of presecriptions antipsychotics to children and youth reflects complex societal, economic poltical and cultural issues," said Dr. Illes. "Not the least of these is widespread for the future promises of neuroscience and molecular medicine." The twin forces of neuroscience and molecular medicine hold the promise of targeted interventions that will address behavioural and emotional problems. 

Ways to Fix the Over-Prescription Problem
"How do we remedy the problem of over-prescription," asked Dr. Illes. "As a start, we need to have a broader conversation about the affordability and accessibility of effective, non-pharmacological health services, such as parent training programs, cognitive behavioural therapy, and social skills training that support youth experiencing mental illness - and their families.

"Health care professionals need to commit to working with all stakeholders in the community, including teachers, youth, parents and other health providers," added Dr. Illes. "If we engage communities in activities that are known to promote wellbeing, we'll promote empowerment and promote existing strengths. We've initiated this kind of cross sectoral approach in Canada, including partnerships to identify effective treatments and procedures, and evidence that can guide safe use of second-generation antipsychotics.

"Although it's important to be optimistic about the future of pharmacological interventions, clinicians need to bridge the gap between the limits of scientific evidence and the needs of patients, particularly in this area of antipsychotic prescribing to children and youth," concluded Illes. 

"Canadian physicians and other health professionals must continue to advocate strongly for cross-modal treatments, including nonpharmacologic ones, and not look too narrowly at molecules for solutions."
 
Recommended resources for health professionals and families:

  • The Provincial Mental Health Metabolic Program at BC Children's Hospital's "Healthy Living, Healthy Minds: a Toolkit for Health Professionals", and the "Healthy Living Toolkit" for families, available at www.keltymentalhealth.ca, and 
     
  • The Canadian Alliance for Monitoring Effectiveness and Safety of Antipsychotics in Children's guidelines at http://camesaguideline.org 
     
  • The Council of Canadian Academies/Health Canada's "Therapeutic Products for Infants, Children and Youth" review of ethical development of safe and effective pharmaceuticals and the labelling of therapies at www.scienceadvice.ca/en/assessments/in-progress/therapeutic-products.aspx 
     
  • Nova Scotia's More than Meds project provides information informed by lived experience for navigating the health system, better care for individuals and families, and educational outreach to communities. www.morethanmeds.com 

 Read the full New York Times article, "Still in the Crib, Yet Being Given Antipsychotics."