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Study: Suicides
increase after ‘black box’ warnings issued
(November
2007 Issue)
By Ami Albernaz
In October 2004, a year after it issued its first public health
advisory regarding suicide risk in children and adolescents taking
antidepressants, the Food and Drug Administration ordered pharmaceutical
companies to add "black box" warning labels on all antidepressants
prescribed to pediatric patients. Meanwhile, in late 2003, health
authorities in Europe warned doctors against prescribing antidepressants
to anyone under 18. Since then, research has shown that while selective
serotonin reuptake inhibitor (SSRI) prescriptions have dropped,
youth suicide rates have risen dramatically. Now, practitioners
are wondering whether the labels are doing more harm than good.
One of the latest such studies, which appeared in the September
issue of the American Journal of Psychiatry and examined in the
U.S. and the Netherlands, bolstered earlier findings in reporting
that after the warnings were issued, U.S. and Dutch prescriptions
of SSRIs for children and adolescents dropped by 22 percent, while
youth suicide rates rose 49 percent in the Netherlands and 14 percent
in the U.S. The U.S. increase, which occurred between 2003 and 2004,
was the country's largest one-year change since data was first collected
in 1979.
Psychiatrists say the problem comes down to difficulties both in
diagnosing depression among children and adolescents and in accessing
necessary treatment. "Clearly the most effective evidence-based
treatment is a combination of cognitive-behavioral therapy, usually
provided by psychologists and antidepressant medication, prescribed
by pediatricians and psychiatrists," says Joseph Gold, M.D., chief
medical officer at McLean Hospital in Belmont, Mass. "There are
not enough people trained to provide CBT, and now there's hesitance
in prescribing SSRIs. It's not surprising the [suicide] rate has
risen."
With not enough child psychiatrists, administering antidepressants
is often left to pediatricians, some of whom have been less inclined
to prescribe since the warnings came out. Harsh Trivedi, M.D., associate
medical director of the adolescent inpatient unit at Bradley Hospital
in East Providence, agrees.
"I've had interactions with pediatricians who in the past would
cautiously prescribe medications and now they wouldn't because they're
concerned that if they have a poor outcome, there could be a medical
liability risk," he says. "[The warnings have] scared away pediatricians
and made them shy away from prescribing something needed."
The National Alliance on Mental Illness (NAMI) has long raised
concerns that the FDA warnings would backfire through antidepressants
being prescribed less. Careful monitoring of children and teenagers
taking the medications is needed, members of the organization say.
"Family members and teachers find that drugs do help [depressed
children and adolescents]," says Diane Holden, LICSW, a mental health
advocate with NAMI Massachusetts. "Children and teenagers need to
be closely monitored, especially at the beginning. Once levels of
the medication are established in the bloodstream, they can reap
the benefits. … We would also advise that drug therapy alone is
not enough and would call for it in conjunction with talk therapy."
Gold and Trivedi say there should be no doubt that medication,
when monitored, can be greatly beneficial in treating depression.
"For those who have carefully analyzed the data and looked at the
safety of SSRIs, the conclusion is adolescents who are depressed
should be carefully monitored, particularly when you're starting
out or raising the dose," Gold says. "However, there should be no
reluctance to use this much-needed treatment."
Gold added that new groups such as the Massachusetts Child Psychiatry
Access Project - a state-funded initiative through which primary
care providers can access psychiatric advice within 30 minutes of
calling, or have a child seen within one week, regardless of insurance
status - are bringing psychiatric support to pediatric practice.
In addition, large pediatric organizations including the American
Academy of Pediatrics are raising awareness of the importance of
antidepressants and proper monitoring.
Successfully treating childhood depression, he says, requires "accessing
all resources at hand, including CBT from psychologists and medication
and monitoring from pediatricians and psychiatrists."
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