So many Canadian children are taking the drugs known as atypical antipsychotics that doctors are being asked to watch for major complications — including dramatic weight gain, tremors, and abnormal face and jaw movements.
Once reserved for schizophrenia and mania in adults, one antipsychotic alone, risperidone, was recommended by Canadian-office-based doctors for children 17 years old and younger a total of 340,670 times in 2010 — a near-doubling since 2006 — according to data provided to Postmedia News from prescription-drug tracking firm IMS Brogan.
Another antipsychotic — quetiapine — was recommended to Canadian children 160,700 times.
The increase in prescriptions for children as young as six is raising concerns that the drugs are being overused. Some experts say too little is known about the effects on a child's cognitive, social and physical development, and that the side effects may set children up for serious health problems later in life.
Overall, from 2005 to 2009, antipsychotic drug recommendations for children and youth in Canada increased 114 per cent, according to new guidelines published in this month's issue of the journal Paediatrics & Child Health on the use of second-generation atypical antipsychotics in children and youth.
The drugs — which have not been approved in Canada for use in children under 18 — are being used for attention-deficit/hyperactivity disorder, conduct disorders, irritability related to autism, mood disorders, physical or verbal aggression and other behavioural problems.
Doctors say that for many desperate families, the drugs are often the only option because of a dismal lack of access to non-drug therapy for children in crisis.
But the drugs also come with some "common and unfortunate" consequences, Canadian researchers say — including a substantial increase in fat mass and waist circumference. Doctors say the drugs can make children so ravenous that some parents have had to lock the fridge.
Researchers have shown that after a median of 10 1/2 weeks of treatment with olanzapine, children gain an average of 8.5 kilograms; their waist circumference increases an average of 8.5 centimetres. The pills can also cause increases in blood pressure, high cholesterol, triglycerides (a type of blood fat) and glucose abnormalities, with some drugs being bigger offenders than others.
"Antipsychotics cause enormous weight gains in children" with all the attendant risks of diabetes, cardiovascular disease and, possibly, a shortened life expectancy, said Dr. Allen Frances, professor emeritus at Duke University School of Medicine, in Durham, North Carolina. Frances is chair of the task force that developed the current edition of the Diagnostic and Statistical Manual of Mental Disorders, or DSM, a massive catalogue of mental illness now undergoing its first major revision in 16 years.
Frances said the drugs are often prescribed "off-label" (meaning they are not Health Canada approved) by primary-care doctors "who have little time and training, without clear indications and with no proven efficacy." He said he worries that proposed changes to the DSM that would expand the diagnosis for some disorders in children while adding new ones — including temper dysregulation disorder — could lead to wider prescribing of antipsychotics to children.
The drugs have been used since the 1990s in the treatment of mental-health disorders in adults. Antipsychotics as a whole were ranked second in Canada, behind cardiovascular medications, as the most prescribed drug class in the country, with 64,853,000 prescriptions filled in 2010, according to IMS Brogan.
Experts say that as doctors have grown more comfortable using the drugs for adults, prescription has spilled over to young people.
As well, public attitudes are changing.
"People's awareness of mental-health disorders overall has improved over the last decade — there's more awareness about it," said Calgary neurologist Dr. Tamara Pringsheim, a member of the Canadian Alliance for Monitoring Effectiveness and Safety of Antipsychotics in Children guideline group.
"When you consider that one in three people will suffer from a mental-health disorder in their lifetime, this is something that happens in every family. People are looking for more help."
The alliance said that multiple randomized controlled clinical trials have looked at the efficacy of many atypical antipsychotics in pediatric mental-health disorders. For many children, though not all children, they're helpful, said Pringsheim, a clinical assistant professor in the department of clinical neurosciences and pediatrics at the University of Calgary.
"I'm not saying they're a panacea . . . I'm just saying that for children with mental health disorders and for families who are really struggling, they can offer some help."
"By no means are these medications a cure for problems," she added. However, "If you can diminish a patient's symptoms by 50 per cent, we consider that helpful."
In many places, Pringsheim said, "the only help that a family can get is medical help. They're not able to access behavioural programs to try and help with aggressive behaviour in a child. It means both the child and the clinician are stuck saying, 'Either this child is going to be in danger daily of hurting themselves and other people, or we can try a medication that may help.' "
Even then putting a child on an antipsychotic is a hard decision for parents to make. "They just hear the name 'antipsychotic' and they're afraid. But some situations become quite desperate."
In addition to weight gain, many of the drugs can cause neurological side effects that can include restlessness and a constant need to move; a decrease in facial expression or a "mask-like" face; abnormal movements of the face, mouth, lips, jaw or tongue; drug-induced tremors and abnormal muscle movements, including neck stretching and writhing.
These extra movements can be "scary and horrible," said Dr. Wendy Roberts, a developmental pediatrician at Toronto's Hospital for Sick Children and professor of pediatrics at the University of Toronto. "They're usually reversible, but we don't have a lot of evidence to say how many might not be reversible. It certainly behooves us to warn parents so they're not taken totally by surprise this is happening."
Pringsheim and her co-authors said doctors need to exercise a "high degree of vigilance" when prescribing the drugs to children and youth.
"I think it is your duty as a clinician," she said. "If we're vigilant, if we are watching carefully, we can avoid a number of these situations just by being proactive.
"If we catch a neurological side effect, if we catch a metabolic side effect early, it's much easier to treat them. Things haven't gone so far that it takes months to get things back to where they were."
She said she believes most doctors are being cautious in using the drugs on children.
"A psychiatrist once said to me, 'Your hand should tremble every time you write a prescription for an antipsychotic medication.'
"And I think most clinicians take that to heart. They're not writing it carelessly or flippantly. They're writing a prescription in an effort to help a child and a family that is clearly suffering."
Others say more needs to be done to ensure doctors understand the limits of the benefits.
"In older children and adolescents with schizophrenia and bipolar disorder — which thankfully are rare — there is good evidence that antipsychotic medications are appropriate and can meaningfully improve the lives of the young who receive them," said Dr. Mark Olfson, a professor of clinical psychiatry at Columbia University.
But the drugs are more commonly given to children with ADHD and other disruptive behaviours, he said. Whether that's appropriate is less clear, according to Olfson.
Before agreeing to put their child on an antipsychotic, experts say parents should ask the doctor what specific symptoms the drug is targeting, and whether there are other options, including parent management training or parent-child interaction therapy for younger children.
I wonder if cowardly parenting has something to do with this growth?