Professional Documents
Culture Documents
The FDA Warning On Antidepressants and Suicidality - Why The Controversy?
The FDA Warning On Antidepressants and Suicidality - Why The Controversy?
cate physicians, to help them understand that although they cannot ignore that small risk, they
can safely manage it by carefully
monitoring their patients, particularly children and adolescents,
during pharmacotherapy.
What should the FDA do in
light of these observational data?
Given that the agencys 2007
modification of the black-box
warning has not been sufficient
to prevent what seems to be a
chilling effect on depression
treatment perhaps the mere
presence of a warning speaks
louder than any clarification it
may contain I believe its unlikely that further modification
would be helpful. I would there-
1668
PE R S PE C T IV E
A Completed Suicides
3.5
3.0
2.5
2.0
0.0
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2010
2011
2012
B Suicide Attempts
300
250
200
150
100
0
2001
2002
C Nonfatal Poisonings
160
140
Accidental
120
100
80
Intentional
60
0
2001
2002
2003
2004
2005
2006
2007
2008
2009
Rates of Completed Suicides, Suicide Attempts, and Nonfatal Poisonings among Children
and Adolescents 10 to 17 Years of Age in the United States, 20012012.
AUTHOR:
Stone
Data are from the Centers for Disease Control and Prevention.
FIGURE:
1 of 1
ARTIST:
ts
they blamed more equivocal advi- not mean that the two phenomAUTHOR, PLEASE NOTE:
sories issued Figure
a year
earlier
rather ena were connected. Critics have
has been redrawn and type has been reset.
Please check
than the public controversy
thatcarefully.
suggested a connection by prehad prompted
those
senting
time series that show a
Issue
date: advisories.
10-30-14
OLF:
Even if suicide or some other steady rate of increase in anti
adverse outcome had worsened depressant-prescription rates and
in 2005, coincident with a decline a steady decrease in suicide rates
in antidepressant use, it would through 2003, and they propose,
1669
PERS PE C T IV E
1670
increased, and promotional expenditures for antidepressants decreased by 35% from 2004 through
2006. It is possible that the modest reduction in antidepressant
prescribing reflected drug makers reduced marketing of brandname antidepressants to everyone except patients who would
soon be eligible for the new Medicare prescription-drug benefit.
Finally, critics have been undeterred when their favored findings cannot be replicated when
better information sources are
used. For example, Lu et al.4
compared the aggregate number
of antidepressant prescriptions
with the aggregate number of
psychotropic-drug overdoses without being able to establish
whether the overdoses were intentional. They used poisoning
by psychotropic agents (without
regard to intent) as a proxy measure for suicide attempts, citing a
study that they claim validates its
use for this purpose, even though
that study did not investigate
whether the relationship between
the proxy and attempted suicide
remains stable over time. Superior data are available from the
Centers for Disease Control and
PE R S PE C T IV E
3. Libby AM, Orton HD, Valuck RJ. Persisting decline in depression treatment after
FDA warnings. Arch Gen Psychiatry 2009;
66:633-9.
4. Lu CY, Zhang F, Lakoma MD, et al. Changes in antidepressant use by young people
and suicidal behavior after FDA warnings and
media coverage: quasi-experimental study.
BMJ 2014;348:g3596.
5. Schumock GT, Gibbons RD, Lee TA, Joo
MJ, Valuck RJ, Stayner LT. Relationship be-
1671
Reproduced with permission of the copyright owner. Further reproduction prohibited without
permission.