The Globe and Mail (February 4, 2004)
By ANDR� PICARD
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.
This article is archived on The Globe and Mail website at:
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Vancouver Sun (February 4, 2004)
6,200 B.C. children on unapproved medication
45 prescriptions were written for children aged six or younger, documents
show
More than 6,200 children in this province are taking anti-depressants that
have shown negative test results and have never been approved for their use.
Documents obtained by Vancouver Sun columnist Daphne Bramham also show that
in
2002, British Columbia doctors prescribed more than twice as many SSRIs, or
selective serotonin reuptake inhibitors, to children and youths than they
did five years earlier.
The data was provided by PharmaNet -- the provincial government's pharmacy
network -- in response to an Access to Information request and showed that
B.C. doctors wrote 49,667 pediatric prescriptions for SSRIs in 2002.
More than 45 of those prescriptions were written for children aged six and
younger -- a group for whom there are no recognized diagnostic tests for
anxiety or depression.
Dr. Jane Garland, director of the mood disorders clinic at B.C. Children's
Hospital, says there have been several trials that have shown the
ineffectiveness of these drugs on adolescents and children, but neither she
nor the physicians who prescribe the medications have been allowed to see
the results.
"There's been 15 anti-depressant trials on young people, but only three of
them were published because the rest were negative -- they showed the
medication didn't work," Garland said.
"That's part of the whole crisis we're in." On Monday, Health Canada issued
a public health advisory to patients aged
18 and younger who are taking one or more of seven types of
antidepressants, including Zoloft, Paxil and Wellbutrin.
The advisory did not recommend children and youths stop taking the drugs,
but said those patients "should consult their treating physician to confirm
that the benefits of the drug still outweigh its potential risks in light
of recent safety concerns."
Last December, Britain made a recommendation against prescribing all
antidepressants except Prozac to patients under the age of 19. In
announcing the recommendation, British health authorities cited research
that suggests certain antidepressants may increase the risk of suicidal
behaviour in children and youths.
Much of that research was from the drug trials that were never published,
Garland said. In the United States, the Food and Drug Administration is
holding public hearings to determine whether antidepressants are safe for
use by patients under the age of 18.
Garland said Health Canada is planning to do a similar review of the drugs,
but added it is "very unlikely" the federal agency will determine the
medications should not be used by young people.
...
PRESCRIPTIONS FOR ANTI-DEPRESSANTS B.C. doctors wrote nearly 30,000
prescriptions for selective serotonin re-uptake inhibitors for children and
teenagers in 1999.
Age Paxil Zoloft Effexor Celexa Prozac Total
0 to 6 83 76 6 0 184 349<
7 to 14 3,544 2,908 731 92 2,900 10,175
15 to 18 7,081 5,595 2,399 281 4,047 19,403 Total
10,708 8,579 3,136 373 7,131 29,927
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