At least five teenagers in Canada have died, four by suicide, while being treated with the most widely prescribed antidepressants in Canada and at least 100 other children as young as 18 months old have experienced adverse reactions to the pills, CanWest News Service has learned.
The most recent reported suicide involves a 14-year-old boy who killed himself after being on Paxil, one of the antidepressants known as selective serotonin reuptake inhibitors (SSRIs), for 25 days.
Health Canada was notified of the boy’s suicide on July 22, 2003, nearly two weeks after the government and GlaxoSmithKline, the makers of Paxil, warned doctors not to prescribe the drug to children and teens because of a possible increased risk of suicidal thinking, suicide attempts or self-harm. Health Canada learned in October 1996 of a 17-year-old boy who committed suicide while he was being treated with Zoloft. A suicide involving an 18-year-old boy who had been taking Prozac was reported to the government in 1992.
In all three suicides, the antidepressants may have contributed to the deaths, according to adverse drug reaction reports contained in an edited, online Health Canada database. It’s estimated only one to 10 per cent of all adverse drug reactions are reported to Health Canada.
But there’s no proof of a cause-and-effect link between the antidepressants and any of the suicides, and it’s not known from the reports whether any of the youth had a history of suicide attempts, or what they were being treated for.
“Health Canada did conduct an assessment to see whether the deaths were caused by SSRIs,” said department spokeswoman Jirini Vlk. “There was no causal link established.”
The fourth suicide involved an 18-year-old girl who overdosed on Effexor; her death was reported to Health Canada in December 1998. The fifth death involved a 16-year-old boy who died of cardiomyopathy, inflammation of the heart, after taking Celexa for 17 days. It is not known from the report, received in May 2003, how long the teen had cardiomyopathy. The youth had also been taking another antidepressant, and possibly an anti-psychotic drug when he died.
According to the doctor who filed the report, Celexa “may be contributory” to the death.
The antidepressants are at the centre of a growing storm over whether SSRIs, blockbuster drugs that have become among the most popular medicines in history, may cause some children to become suicidal or trigger other severe emotional or behavioural changes within weeks of treatment starting or a change in dose.
New York State Attorney General Eliot Spitzer last week launched a lawsuit against GlaxoSmithKline, alleging the drug giant “engaged in repeated and persistent fraud” by concealing critical scientific studies about the safety and efficacy of Paxil for depression in children and adolescents, a charge the company denies. “All pediatric studies have been made available to the FDA (U.S. Food and Drug Administration) and regulatory agencies worldwide. We have publicly communicated data from all pediatric studies,” the company said.
Today, preschoolers make up the fastest growing segment of the SSRI market, studies show. Even infants under one are being prescribed the drugs for anxiety or sleeping problems.
Health Canada records reveal the government began receiving reports of agitation, hostility, aggression, hallucinations, psychotic states, impulsive behaviour, paranoid reactions and other suspected drug reactions in children on SSRIs at least five years ago.
Yet a public advisory warning parents to rigorously watch their children for signs of unusual or disturbing behaviour, including wanting to harm themselves or others, wasn’t issued until last week. And while British authorities ordered doctors six months ago to stop prescribing the antidepressants to anyone under 18, Health Canada has decided against barring their use in children or restricting their use to trained doctors who have the time to do a proper assessment and follow-up, even though none of the drugs have ever been approved for use in children in Canada.
A recent analysis by Health Canada of all adverse reactions experienced by patients taking SSRIs found no direct link between the drugs and incidents of death.
Critics say the story of how SSRIs have become among the top drugs prescribed to children is a saga of biased reporting, bureaucratic breakdowns and flawed assumptions that what would work in adults would work in children, a “disaster,” the world’s top medical journal The Lancet says, that has led to spiralling prescriptions for SSRIs for toddlers, grade-schoolers and adolescents without any evidence most of them work much better than placebos, or fake pills.
Some parents swear the medications gave their children full, happy and functional lives. Medical groups such as the American Psychiatric Association fear the controversy will scare doctors away from prescribing the drugs or keep people who need help from getting treatment.
But critics, including some of Canada’s leading child psychiatrists, worry the antidepressants are being handed out like candy, and that their soaring use reflects our busy society’s growing intolerance for moodiness, shyness, anxiety and other normal life problems in children.
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