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Powerful antidepressant and antipsychotic drugs approved only for use in adults are suspected of harming — in some cases killing — Canadian children.
Though Health Canada and the drug makers acknowledge the drugs are not approved for use in anyone under 18, doctors — often general practitioners with little psychiatric training — are prescribing these medications with little oversight.
Health Canada told the Star it has no jurisdiction to deal with the problem.
The regulator concedes the drugs may hurt kids but said it is up to drug companies to communicate the risks and doctors to safely prescribe the medications.
A Star investigation has found nearly 400 cases of children and teens suffering serious, sometimes fatal side effects suspected to have been caused by these drugs since 2002.
A 9-year-old boy’s breath shortened, stomach twisted and balance faltered before he died while on three different antipsychotics.
A 15-year-old boy experienced an irregular heartbeat and convulsed before killing himself while on antipsychotic Seroquel.
A 15-year-old girl on Prozac took her life in 2011.
Twenty-eight cases resulted in death, including the suicide of a 9-year-old boy three weeks after he started taking Zoloft, an antidepressant, in 2006. Convulsions and suicide attempts were among the most frequently reported suspected side effects.
“The prescribing of drugs falls within the practice of medicine . . . (Doctors’) professional judgment includes prescribing a drug to treat a condition for which it is not specifically authorized by Health Canada,” the country’s health watchdog told the Star.
Pfizer Canada, maker of Zoloft and Effexor XR, also an antidepressant, and three other drugs reviewed by the Star, said: “These medicines have not been approved for pediatric use by Health Canada. Pfizer Canada cannot recommend the use of any of its medications outside of product labelling.”
In about 35 per cent of the cases reviewed by the Star, kids 12 and younger were reported to have suffered serious side effects, including a 5-year-old girl who suffered seizures while on the antidepressant paroxetine (a generic version of Paxil), and a 6-year-old girl who experienced aggression, panic and personality disorder while on antidepressant Effexor XR.
“I am gobsmacked when I hear that. Why on Earth is a doctor putting a 5- or 6-year-old on a psychotropic drug? They’d better have a good reason,” said Dr. David Juurlink, head of the clinical pharmacology department at Toronto’s Sunnybrook hospital and a drug safety researcher.
So little is known about how these powerful drugs affect youth that the product pamphlets say the pills are not recommended for those younger than 18.
Pfizer and other drug companies say a lack of “sufficient clinical experience” or proven “safety and efficacy” are reasons why the drugs are not approved for kids. GlaxoSmithKline, maker of antidepressant Paxil, said “clinical studies . . . failed to demonstrate efficacy.”
Yet doctors are allowed to prescribe these drugs in what is known as an “off-label” use of the medication.
Each of the nearly 400 adverse reaction reports reviewed by the Star is the opinion of the doctor, pharmacist or parent that a particular drug has caused a side effect. Patients’ names and locations are taken out of the reports to protect their privacy.
About 75 per cent of the side-effect reports reviewed by the Star were made by doctors and other health-care professionals, and done so voluntarily. Canada’s flawed federal drug safety law does not require doctors to report side effects, even serious ones.
Health Canada and drug companies say side-effect reports show only a suspected connection between the drug and side effect but no medical proof that one caused the other.
The Star’s data analysis showed antipsychotic risperidone was named as the suspected cause in nearly 70 serious side-effect reports — more than any other drug reviewed by the Star.
Paxil was listed as the suspected cause in more than 50 cases, including six deaths.
Earlier this year, the U.S. Justice Department slapped GlaxoSmithKline, maker of Paxil, with $3 billion in fines following government allegations that, among other things, the company promoted the drug for use in kids while concealing evidence that it was ineffective.
Australian child psychiatrist Jon Jureidini, who has extensively researched Paxil’s safety and effectiveness in youth, said, “none of the antidepressant trials in children show any clinical advantage of the drug over a placebo. The ones that claim to have (shown such an advantage) have all got flaws in them, either scientific or in the way that they’re presented. That means we have no evidence at all to support the use of antidepressants in children.”
The problem is that many doctors, as well as Health Canada — which sends advisories and warnings about drugs to the medical community — do not know very much about the medications.
“We don’t know a lot about it simply because there is still a lot we don’t know about the brain. You will find fewer studies that look at this age group compared to adults with depression,” said Dr. Amy Cheung, a psychiatrist at Sunnybrook hospital who treats teens with depression. “There’s enough research data out there to show antidepressants are beneficial in the majority of teens with depression but in a small percentage of cases, patients can experience serious side effects.”
Some kids need the drugs. Dr. Cheung said she has seen children under 12 developing serious, debilitating mental illness such as anxiety, depression or schizophrenia and requiring medication.
Relying on their own experience practicing medicine, scientific journal articles and other sources, doctors can prescribe these drugs to kids. Many of the drugs are dispensed with pamphlets that warn of suicidal thinking and actions, and other possible side effects.
British Columbia’s government has issued guidelines for physicians diagnosing and treating children with depression. Doctors are directed to try “basic interventions” and therapy before resorting to prescribing pills.
In Ontario, however, neither the Ministry of Health nor the College of Physicians has a policy specifically on prescribing these unapproved drugs to children. (Non-regulatory professional associations such as the Canadian Academy of Child and Adolescent Psychiatry issue practice guidelines.)
• More and more kids are taking these drugs. Health Canada estimates prescriptions of antipsychotic drugs to children and teens in Canada spiked 114 per cent from 2005 to 2009.
• Health regulators around the world have published warnings that antidepressants may increase the risk of suicidal behaviour in kids and teens. The Star found these drugs were associated with 17 youth suicides and 28 suicide attempts in Canada since 2002.
To see a child psychiatrist can take more than a year in some parts of the province, and in less urban areas access to expertise is even more restricted, said Dr. Cheung, who added that talk therapy is often only available to those with private health insurance.
“Most family doctors have only a small proportion of their medical training focused on mental health compared to the training they receive in the diagnosis and management of physical illnesses,” she said. “But a large proportion of their child and adolescent cases are actually related to mental health issues.
“When a patient comes to you, depressed for three years and considering taking their own life, you try to do what you can for that teenager. Medication is one of the things you should consider as part of the treatment plan along with talk therapy.”
Depression experts urge caution when reviewing side-effect reports because depressed kids, before starting medication, are already at greater risk of suicidal behaviour. As a result, it can be difficult to tell whether suicidal thinking is caused by a teen’s depression or the drug used to treat the depression.
Still, doctors worry about their widespread use.
“The next time a girl is in your office crying that her boyfriend broke up with her, that’s not a reason to prescribe an antidepressant,” said drug safety expert Dr. Juurlink. “Doctors are part of the problem. We are way too free with our prescription pads. Partly we have a desire to do something helpful and partly we have a desire to get to the next patient.”
It is crucial that doctors closely monitor young patients, especially during the first few weeks of medication. “That’s when the “s--- tends to hit the fan,” Juurlink said.
In 99 cases, the Star found children and teens suffered suspected serious side effects a month or less after starting the drug. In one case, an 8-year-old boy developed facial spasms and his muscles began to involuntarily twist and contract three days after he began taking risperidone, an antipsychotic.
Overworked or inexperienced doctors, however, may not closely track their patients, or the patient may skip follow-up appointments.
“Medical clinics are often not set up to allow doctors to closely track patients who miss appointments. Doctors also cannot force teens to return for appointments,” Dr. Cheung said. “It is critical that families try to help ensure these teens make it to their appointments.”
A recent review of the effect of risperidone and other antipsychotics on children found an increased risk of weight gain and movement disorders when compared to kids on placebos.
Calgary doctor and researcher Tamara Pringsheim, who did the study with funding from the Canadian Institutes of Health Research, said doctors and families of patients need to aggressively monitor kids on these powerful drugs.
“The most common reason an antipsychotic is being prescribed is not for schizophrenia but for ADHD,” she told the Star, adding that she has developed and is now promoting guidelines doctors should follow to detect side effects. “I felt physicians do need some guidance on how to keep it safe.”
Some countries take regulation of these drugs seriously.
In the GlaxoSmithKline case, the company pleaded guilty to criminal charges stemming from its failure to report safety data and “unlawful promotion” of certain drugs.
Part of the U.S. investigators’ case focused on the now infamous Study 329 on Paxil.
In a 2001 report, Study 329’s authors claimed their research showed Paxil was “generally well tolerated and effective for major depression in adolescents.”
The report became one of the most cited pieces of medical literature in support of antidepressants for youth, and an internal memo to Paxil’s sales representatives lauded it as a “landmark study” that “demonstrates REMARKABLE Efficacy and Safety (sic).”
But the results were skewed by selective reporting, said Dr. Jureidini, who co-authored a 2008 journal article on Study 329’s inaccuracies.
Study 329’s authors exaggerated findings on Paxil’s effectiveness and downplayed serious adverse reactions, Jureidini and his colleagues found.
Last year alone, Paxil was named the suspected cause of serious side effects in youth in eight reported cases.
“If you look at the science of Paxil, it says it shouldn’t be used at all in children,” Jureidini said. He said it’s “surprising and disappointing” that Canadian doctors are still prescribing the drug to kids and teens.
GlaxoSmithKline said Study 329’s authors “fairly presented the results” of the study and the company disputes “allegations that the … (2001) article on Study 329 was false or misleading.”
GSK said its plea with the U.S. Department of Justice regarding Paxil concerned only “some occasions when GSK sales representatives in the U.S. promoted the use of Paxil to physicians for patients under the age of 18, an unapproved use.
“The matters resolved as part of this settlement do not reflect the company we are today.”
In the U.K., the health regulator issued a blunt statement to doctors in 2003 that many antidepressants “are not suitable” for those younger than 18.
Many of the product pamphlets say the drugs “should not be used” by youth. Meanwhile, in Canada the language in the pamphlets distributed to doctors and patients is less forceful. They say the drugs are “not recommended,” “not indicated” or “not for use” in youth.
“The difference in language is probably a major deterrent,” said Dr. Juurlink. “When a doctor is told they should not do something, they generally don’t do it, or they think long and hard before they actually do. Simple changes in the wording are important.”
Several doctors told the Star that Health Canada is not doing enough to ensure drugs prescribed for unapproved uses are safe or effective.
Health Canada should track these off-label uses of drugs and check whether the unapproved treatments are medically sound, said Dr. Tewodros Eguale of McGill University.
Eguale led a recent study that found 11 per cent of roughly 250,000 prescriptions given to Quebec patients from 2005 to 2009 were for unapproved uses.
The study found antipsychotic drugs quetiapine and olanzapine were most often prescribed for unapproved treatments, such as depression and mood disorders, for which there is no strong evidence they are effective.
Without an effective treatment, a patient’s depression could worsen and lead to self-harm, he said.
Health Canada is “responsible for the safety and effectiveness of the drug and they’re also responsible for the general public’s health,” Eguale said. “It’s time to really look at the effect of when these drugs are used off-label.”
For Dr. Juurlink, the problem is more fundamental. “We would be facing a much less grave situation with regard to drug safety concerns if physicians were simply less eager to prescribe medications and patients less eager to take them.”
Data analysis by Andrew Bailey
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