Mounting concerns over the safety of prescribing a new generation of anti-depressants to children and teenagers has prompted Health Canada to issue a rare public warning to reconsider their use because the popular drugs may actually increase the risk of suicide.
In an advisory on its website, the health watchdog said all Canadians under the age of 18 who are taking one of seven suspect prescription drugs should immediately “consult their treating physician to confirm that the benefits of the drug still outweigh its potential risks.”
The seven drugs are: Prozac, a product of Eli Lilly; Paxil by GlaxoSmithKline; Celexa by Forest Laboratories; Luvox by Solvay Pharmaceuticals; Remeron by Akzo Nobel; Zoloft by Pfizer; and Effexor by Wyeth. All belong to two newer classes of drugs, selective serotonin re-uptake inhibitors (SSRIs) and serotonin noradrenaline re-uptake inhibitors (SNRIs).
Health Canada said its action was prompted by international studies that linked use of these drugs to “suicide-related events,” suicides and suicide attempts.
It stressed that the warning does not apply to adults. In Canada, these anti-depressants are not approved for use in children and adolescents, but they can be prescribed to them by physicians in a practice known as off-label use.
More than 11 million U.S. children are prescribed SSRIs and SNRIs annually. No data are available for Canada, though it is expected that more than three million Canadians will take these classes of anti-depressants this year.
The move yesterday by Health Canada follows belatedly action taken in Britain and the United States.
In December, Britain banned the prescription of six of the newer anti-depressants to children and teenagers because of a growing body of evidence linking their use to “suicide-related events.” (It exempted Prozac from the list.)
The U.S. Food and Drug Administration, for its part, has appointed an advisory panel that is holding public hearings on the issue.
The panel said this week that the drugs should feature a warning label about the increased risk of suicide. In addition to the seven drugs named in the Health Canada warning, the FDA is investigating Wellbutrin, a product of GlaxoSmithKline and Serzone by Bristol-Myers Squibb.
Jirina Vlk, a spokeswoman for Health Canada, said Canada will soon have its own advisory panel to examine the issue, but public hearings are unlikely. She said the federal Health Department will take further action when it receives recommendations from the panel.
“Health Canada will take all necessary measures based on the recommendations of the advisory panel,” Ms. Vlk said.
Mike McBane, spokesman for the Canadian Health Coalition, a consumer group funded by labour unions, accused Health Canada of foot-dragging and pandering to the interests of pharmaceutical companies.
He said that a formal “Dear Doctor” letter should be sent to all physicians about the risks of SSRIs and SNRIs to children; that warnings should go on labels; and that an advisory posted on a website is clearly inadequate.
“Who will see this lame warning?” Mr. McBane wondered.
The link between anti-depressants and an increased risk of suicide and violent behaviour was first made by British researcher David Healy.
At a conference last week in Ottawa, he said that, since 1988, over-prescription of the new generation of anti-depressants caused between 2,000 and 7,000 suicides in Canada.
In testimony at the U.S. hearings, Dr. Healy was also highly critical of the volume of prescriptions written for these powerful drugs, particularly to children and teenagers. But he said the answer is more information, not an outright ban.
“I think these drugs have a place, even in this age group, but my ability to use these drugs safely is going to be enhanced if they come with the right warnings,” said Dr. Healy, director of the North Wales Department of Psychological Medicine.
In 2000, Dr. Healy made headlines when he was offered a job at the Centre for Addiction and Mental Health in Toronto, only to see it revoked after he gave a speech on SSRIs and suicide.
The centre, a University of Toronto teaching hospital, denied that its decision had anything to do with the fact that Eli Lilly, the maker of Prozac, was a major donor. But a major flap about academic freedom ensued, and the issue of anti-depressants and suicide was thrust into the public spotlight.