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SHARON AESCHBACH'THEM™
Jim Spencer from Wichita, Kan., holds anti-abortion
signs behind the Academic Building Monday afternoon.
Spencer has been a part of the organization^
All since 1996.
FDA urges monitoring
for antidepressant users
By Lauran Neergaard
THE ASSOCIATED PRESS
WASHINGTON — Doctors who prescribe
some popular antidepressants should monitor their
patients closely for warning signs of suicide, espe
cially when they first start the pills or change a
dose, the government warned Monday.
The Food and Drug Administration asked mak
ers of 10 drugs to add or strengthen suicide-relat
ed warnings on their labels.
The agency insists it’s not yet clear whether the
drugs actually spur suicide on occasion — or
whether the underlying mental illness is to blame.
But FDA bowed to pressure from anguished fam
ilies who, at an emotional meeting last month,
blamed the pills for their loved ones’ suicides and
pleaded for better warnings.
It’s a difficult issue to sort out because depres
sion itself can lead to suicide, and studies clearly
show that antidepressants have helped many peo
ple recover from depression.
Still, until the question is settled, FDA’s own
scientific advisers had urged stronger warnings
that certain antidepressants may cause agitation,
anxiety and hostility in a subset of patients who
may be unusually prone to rare side effects.
Monday, FDA followed that recommendation,
stressing that the most vulnerable time is when a
patient starts therapy or changes the dose.
“We think this is good advice whether the
drugs increase the risk or not,” said FDA medical
policy chief Dr. Robert Temple. “There’s a reason
people are put on therapy — their depression is
worse or somebody’s worried about it. Maybe
that’s what drives it (reports of suicides) or maybe
it’s the drugs. In either case, you really need to pay
attention in the early days.”
While FDA’s investigation into the possible
suicide link initially focused on children and
teenagers, Monday’s wanting includes adults,
too. The FDA had investigated reports of sui
cide among adult antidepressant users in the
early 1990s and concluded there was no link —
but on Monday revealed that it is reanalyzing
that question.
The drugs of concern are newer generation
antidepressants: Prozac, Paxil, Zoloft, Effexor,
Celexa, Lexapro, Luvox, which are called SSRIs
or SSRI-like drugs, and Remeron, Serzone and
Wellbutrin, which operate differently.
Manufacturers didn’t immediately say if
they’d comply.
British health authorities sounded the alarm
last year, saying long-suppressed research sug
gests serotonin-affecting antidepressants might
sometimes increase the risk of suicidal behavior in
children and teenagers. Excepting only one drug,
Prozac, that has been proven to alleviate pediatric
depression, Britain declared the other six SSRIs or
SSRI-like drugs unsuitable for depressed youth.
Britain didn't mention the other three drugs listed
in the U.S. notice.
FDA issued a caution on pediatric use last year
Antidepressants,
use with caution
The Food and Drug
Administration recommends that
certain antidepressants include
a warning for worsening
depression or suicidal thoughts
There were over 213 million
dispensed prescriptions for
antidepressants in 2003.
Dispensed prescriptions
for antidepressants, 2003
in millions
..
Others
(incl.
Lexapro,
Luvox,
Remeron,
Serzone,
Wellbutrin)
106.2
Paxil
17.1
32,1
Prozac
- 22.2
‘Effexoi
18,
Celexa
17, :
SOURCE: IMS Health
Ai
but says it doesn’t yet have proof thedrugsU
blame. Among 25 studies of the suspecting
tions involving 4,000 children and teens,
were no completed suicides. Some I09p
experienced one or more possibly suicided
behaviors or attempts — but the studies'!
dramatically in what was considered
behavior. For example, among 19 patients#
fied as cutting themselves, almost all weresif qj,
ficial, with little bleeding.
But critics flooded an FDA meeting last
demanding stronger action — and days
issue again made headlines when a \9-p
woman taking part in a study of Eli Lilly
experimental new antidepressant dt
hanged herself in a company-run facility.
Most antidepressant labels already col
some fine-print statement about suicide, os 1
that the possibility is inherent with depressit*
FDA asked Monday for explicit explain
of worrisome behavior changes to be plao
bold print under the prominent “warnings
tion of those labels: agitation, anxiety, irri^
and recklessness. Doctors spotting those E 1
should consider prescribing a lower dose ot' 1
ping the drug, FDA said.
The drugs are used for many conditions
than depression; the warning applies regard!
the reason for use.
Critics welcomed the change but said s' 1 *
complaints first were raised many yearsago