Paragraphs 16 & 17 read: "Still, Dr. Jane Garland, clinical head of the Mood and Anxieties Disorders Clinic at British Columbia's Children's Hospital, says there is definitely a subgroup of pediatric patients who experience obsessive suicidal thoughts after going on the medication. "
"'I had a 16-year-old patient on (an SSRI) call me shortly after she began taking it and she was overwhelmed by the thoughts of suicide and self harm she began feeling,' Garland says. The patient had never experienced such severe thoughts of self-harm before taking the drug, Garland says."
Are mood drugs helping our kids?
From all appearances Gareth Christian was an artistic, intelligent young man with a great sense of humour, excited at the prospect of starting his own snowboarding company.
So when the 18-year-old Vancouver resident committed suicide in January, 2002, his friends and family were shocked.
"He was just so loved in the community," says his mother Leslie Fenn Christian. "About 1,400 people came to his funeral."
She is convinced her son's death was linked to the SSRI antidepressant medication he had first been prescribed when he was 17 ? pills that the U.S. drug watchdog this week declared in need of stiffer warning labels for adults and children because they may increase the risk of suicide in some patients.
Christian had been on the medication for six months after experiencing a mild bout of depression. But several weeks before his death, he stopped taking it because it made him agitated and aggressive.
"They never tapered him off and he had an extreme reaction," she says. "It seemed he was getting better and then ... that was it."
Though the grieving mother tried to find out if the drug was a possible cause of her son's suicide, she could never get a definite answer.
The U.S. Food and Drug Administration warning is another step taken by regulatory bodies and medical experts worldwide to address concerns that the pills may be linked to suicide, violence and aggression among patients 18 and under.
This week, Health Canada announced it will require drug makers to change the labelling on the drugs to include stronger warnings about concerns related to possible suicide by those 18 and under.
The drugs ? citalopram (Celexa), fluoxetine (Prozac), fluvoxamine (Luvox), mirtazapine (Remeron), paroxetine (Paxil), sertraline (Zoloft), venlaflaxine (Effexor) ? are not approved for use in people under 18 in Canada. But they have been increasingly prescribed for this group "off-label." Doctors who have been prescribing the pills to patients under 18 will still be allowed to do so.
That means a doctor can prescribe them for children if he or she believes it will be of benefit. Most of the drugs are prescribed by family doctors and pediatricians as there are so few child psychiatrists in Canada.
"No one told us that the drug was not approved for young people," says Fenn Christian. "No one ever warned us there could be unusual ... side effects."
Figures from the medical research firm, IMS Canada, show the number of times SSRIs were recommended for children in this country over the past five years has increased significantly. Last year, SSRIs were recommended to pediatric patients 522,000 times. That compares to 343,000 times in 1998.
Health Canada cautions that no one should abruptly stop taking any of these medications as they must be cut back gradually to avoid potential serious withdrawal effects. It has also asked the manufacturers of the drugs for a thorough review of the worldwide safety data for their use in children. It convened a special scientific advisory panel in February and will release its recommendations at the end of the month.
The FDA has alerted doctors and patients to watch for signs of suicide during the first few weeks the drugs are prescribed and whenever their dose is changed. The move comes after a hearing last month when scores of parents reported how their children became suicidal or violent after taking the drugs.
Because suicidal thoughts are common among depressed patients, many experts say it is impossible to tell if the drugs or the disease is the cause.
Still, Dr. Jane Garland, clinical head of the Mood and Anxieties Disorders Clinic at British Columbia's Children's Hospital, says there is definitely a subgroup of pediatric patients who experience obsessive suicidal thoughts after going on the medication.
"I had a 16-year-old patient on (an SSRI) call me shortly after she began taking it and she was overwhelmed by the thoughts of suicide and self harm she began feeling," Garland says. The patient had never experienced such severe thoughts of self-harm before taking the drug, Garland says.
She believes the drugs "tweak" certain mechanism in the brain that may reduce or increase suicidal tendencies in specific groups of patients. It has been documented that even some normal people who are not depressed will become obsessed by thoughts of suicide and self-harm when put on the medications, she says. She thinks doctors can use the drugs, but only if the patient is at severe risk due to their psychiatric condition and after other measures ? such as cognitive therapy, improved diet, exercise and sleep fail to achieve results.
Many doctors were upset this past year when they found out drug companies did not report studies that showed the drugs were not effective in pediatric patients. Since the drugs were already approved for adults they were not obliged to report the negative data from studies of pediatric patients, Garland says.
But not reporting such data puts doctors "in a very awkward position" says Kathryn Clarke, spokesperson for the Ontario College of Physicians and Surgeons. Doctors need that information to make an educated choice about prescribing the drugs, she says.
However, spokespersons for makers of three of the drugs ? Paxil, Luvox and Remeron ? say they have obeyed all laws and regulations.
"This is not penicillin where we can see in a test tube how it works," says Dr. Clive Chamberlain, adolescent suicide expert with the Centre for Addiction and Mental Health, who was a member of Health Canada's scientific advisory panel looking into the use of the drugs on pediatric patients.
Chamberlain says there is not enough research into the effectiveness of the drugs in people under 18. However, he says anecdotal and clinical reports show they do help many people. But the reports of suicidal thinking and violence and aggression on the drugs are also anecdotal, he says.
Doctors are put in a difficult position where they have to weigh possible adverse effects from medication in a depressed young patient, including the real risk of suicide, against possible benefits. Chamberlain says he believes the drugs do work for many pediatric patients but they must be monitored very carefully.
He says more independent research ? research not funded by drug companies ? is needed to determine if, how and when the drugs should be used.
Dr. Mark Sanford, head of the child mood disorder service at the Centre for Addiction and Mental Health, says though there is a "great deal of alarm" the dangers are probably exaggerated.
Sanford says "40 to 60 per cent of patients" 18 and under who are severely depressed will be actively suicidal at some time. He says it is important to conduct more research on the use of the drugs in children. He points out that in his clinical experience the drugs do help many patients.
Patients such as Jonathan Singh, 18, who has been taking an SSRI for a year for depression, say the drugs work wonders. The Toronto area youth says the drug has "turned my life around." Before he took it he was so depressed, he failed a year at school.
No one really knows how the drugs work but they are believed to alter the chemistry of neurotransmitters ? serotonin, norepinephrine and dopamine ? in the brain. And because studies have shown about 80 per cent of pediatric patients prescribed drugs for depression get better on placebo, it is hard to tell how effective they are.
But last month, Garland wrote in the Canadian Medical Association Journal that the evidence showing SSRIs work in children is "weak or non-existent." She says that observations in some clinical trials and case reports show up to 25 per cent of children placed on SSRIs for any disorder will have other adverse psychiatric effects including agitation, irritability and out of character behaviour.
A trial of adolescents on one SSRI found 10.5 per cent stopped because of serious psychiatric effects ? the most common being "suicidal ideation/gestures, conduct problems or hostility and aggressiveness," she says.
Another concern among doctors is the number of children on the drugs who are taking more than one psychoactive medication. A study by the American Psychological Association found 42 per cent of children are given two or more medications affecting their central nervous system and 10 per cent were prescribed two or more antidepressant medications.
Fenn Christian says no unapproved drugs should be used on minors unless the patient and parents are informed of all possible problems. She wants the drugs prescribed only by specialists in pediatric psychiatry.
Though the FDA did not conclude the drugs cause suicide, it warned that emerging or worsening thoughts of suicide "might be a result of drug therapy." It also warned that "anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, (severe restlessness), hypomania, and mania" were reported in children and adults on the drug. Patients with these symptoms "may be at increased risk for worsening depression or suicidality ... . Medications may need to be discontinued, when (such) symptoms are severe, abrupt in onset" or not present before the drugs were begun, it warned.
A spokesperson for the makers of Paxil, GlaxoSmithKline Inc., says the firm is committed to working with the FDA, Health Canada and other medical experts. The firm discloses all data about its products to health officials and drug regulators as soon as possible, the spokesperson says.
A spokesperson for Solvay Pharma Inc., the maker of Luvox, says the firm has provided Health Canada with all the data it requires on the use of the drug in children.
A spokesperson for Organon Canada Ltd., which makes Remeron, says some of the symptoms that sparked the label change do not occur in Remeron. The drug is not associated with an increase in suicidal thoughts, it says.
Additional articles by Robin Harvey