FDA Wants Suicide Warning Labels on Antidepressants
Monday, March 22, 2004
WASHINGTON — Patients on some popular antidepressants should
be closely monitored for warning signs of suicide, the
government warned Monday in asking the makers of 10 drugs to
add the caution to their labels.
Although the Food and Drug Administration's investigation
into the possible suicide connection initially focused on
children given the drugs, its warning is aimed at both adult
and pediatric use.
It isn't clear yet that the drugs actually do lead to
suicide, the FDA stressed. But until that is settled,
advisers to the FDA called last month for stronger warnings
to doctors and parents that the antidepressants may cause
agitation, anxiety and hostility in a subset of patients who
may be unusually prone to rare side effects.
On Monday, the FDA followed its advisers' recommendation and
issued a public health advisory putting doctors, patients,
families and other caregivers on notice to be particularly
vigilant for signs of worsening depression or suicidal
thoughts at the beginning of anti-depressant therapy or
whenever the dose is changed.
The drugs of concern are all newer-generation
antidepressants: Prozac, Paxil, Zoloft, Effexor, Celexa,
Remeron, Lexapro, Luvox, Serzone and Wellbutrin. Most are
known to affect the brain chemical serotonin
British health authorities sounded the alarm last year,
saying long-suppressed research suggests certain
antidepressants might sometimes increase the risk of
suicidal behavior in children and teenagers.
Because only one drug, Prozac, has been proven to alleviate
pediatric depression, Britain declared others — drugs called
selective seretonin reuptake inhibitors (SSRIs) and their
close relatives — unsuitable for depressed youth.
The FDA issued a caution on pediatric use last year, but
Monday's action — especially the addition of the warning to
drug labels — goes significantly further.
Dozens of anguished parents pleaded with FDA in a meeting
last month to add such warnings, citing preteens and
teenagers who hanged themselves or slashed their wrists
shortly after starting the antidepressants.
Parent after parent described children who had become
extremely agitated or anxious shortly after starting the
antidepressants, and seemingly sudden impulses that
turned deadly.
foxnews.com0,2933,114841,00.htmlOpen ↗
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"For oral administration, to adults only. Children: Not recommended."
Prozac (Fluoxetine) 'Abbreviated Prescribing Information', Eli Lilly &
Co.
"[T]he only drug that has received approval for use in children with
major depressive disorder is fluoxetine (Prozac)." FDA Talk Paper,
Public Health Advisory on Cautions for Use of Antidepressants in
Adults and Children. Mar 22 04.
groups.msn.compsychbustersOpen ↗
Decoding Psychiatric Propaganda