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FDA: Anti-depressants
must carry
'black box' warning
(November
2004 Issue)
By Jennifer Elise Chase
The Food and Drug Administration has mandated that all antidepressant
medications must carry a "black box" warning, alerting to doctors,
patients and parents their risk of suicidal thoughts and behavior
or "suicidality," in the children and adolescents who take them.
The warning will also emphasize to doctors the need to closely monitor
patients started on these medications.
The October 15 mandate followed a September hearing in Washington,
D.C. where a 23-person panel of federal health advisors told the
FDA that nine medications should carry a "black box" warning, or
an information sheet from the drug companies to accompany the medications,
stating that they can cause suicidal thoughts and self-injurious
behavior in patients 18 and younger.
Panel members told the FDA that Prozac and the other "new generation"
antidepressants are causing suicidality in two to three percent
of children under age 18, or 20,000-30,000 per the one to two million
adolescent patients who take them.
The medications recommended for the label are: Prozac, Zoloft,
Wellbutrin, Celexa, Effexor, Remeron, Paxil, Serzone, and Luvox.
Prozac is currently the only FDA-approved adolescent antidepressant,
but doctors regularly prescribe other drugs of the same type, called
"selective serotonin reuptake inhibitors" or SSRIs.
FDA has also said that a Patient Medication Guide (MedGuide) is
being made which will be given to patients receiving the drugs advising
them and their parents of the risks and precautions that can be
taken to ensure their safety.
"For the most part [the FDA] will usually insist on our interpretation
of the data, being the data that is put into the label" says Sandra
Kweder, M.D., acting director of the FDA's Office of New Drugs,
Center for Drug Evaluation. "Sometimes the specific words are what
ends up being negotiated but it is the FDA's interpretation of the
data that will go into the label."
Kweder expects FDA will send text of the labels to manufacturing
companies within the next several weeks. The FDA is hopeful that
consumers will have access to the guides within the next four to
six weeks.
The FDA has included all antidepressants in the new warning for
adolescents - both new and some "older generation" antidepressants.
According to Russell Katz, M.D., director of the FDA's Neuropharmacological
Drug Products Center for Drug Evaluation and Research, research
supports that several antidepressants in other classes caused patients
to exhibit the same suicidality.
"The signals seem to be pretty much consistent across the drug
classes that were studied," says Katz. "For that reason we considered
that this effect most likely related to antidepressants widely defined."
The "black box," which according to the FDA is the most serious
labeling that can appear on any medication, does not prohibit the
use of antidepressants in children and adolescents.
"Adolescents do respond very well to these medications," says Carol
M. Wester, RN, MSN, APRN, of Hopewell Associates in Mattapoisett,
Mass. "The National Institutes of Mental Health has reported that
suicide rates among children and adolescents have fallen over the
past several years; [but], does that mean that these medications
are actually responsible for that encouraging trend? It is difficult
to know how to interpret the trends and data."
Hopewell Associates specializes in treating adolescents with Autism
Spectrum Disorders and many of its patients suffer from symptoms
of depression. Wester says that a black box warning cannot substitute
for good clinical judgment and practices. But a warning in clear
view is ultimately a good idea.
"It may scare some people away from treatment; it may increase
the liability of the prescriber; it may dampen direct advertising
in the popular media to patients and their parents; it may drive
down the cost of drugs a bit via the increased prescribing of generic
[Prozac] … but the problem is that at the end of the day, we still
have a population of depressed children and adolescents who are
suffering," she says.
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