In 2004 the FDA issued a black box warning about the increased risk of suicidality in children
taking the newer antidepressants, including the SSRIs (Prozac, Zoloft,
Paxil, Luvox, Celexa, and Lexapro) and also Effexor and Wellbutrin
(also marketed as Zyban). On June 30, 2005 the FDA published a Public
Health Advisory warning of the possibility of increased suicidality in adults
treated with antidepressants. The FDA followed this on July 1, 2005
with a Talk Paper elaborating on the potential risk and the agency’s
plans to study the problem further. All of these documents are
available on www.fda.gov.
The FDA should have issued these warnings at least a decade ago. I
first began writing about antidepressant-induced suicidality in 1991.
At that time I identified drug-induced suicidality as part of a much
larger problem—antidepressant-induced activation or stimulation similar
to that caused by amphetamine, methamphetamine and cocaine.
Antidepressant stimulation can lead to violence as well as suicide and
a wide variety of abnormal and even psychotic behaviors.
Prozac was introduced to the American public in January 1988. Three years later in my book Toxic Psychiatry
(St. Martin’s Press, New York, 1991) was published. In that book, as
well as in many later books and scientific articles, I made the
All of the newer antidepressants can stimulate the brain. The
results of stimulation are similar to the effects of amphetamine,
methamphetamine, methylphenidate, and cocaine. Stimulating the brain
leads to anxiety, agitation, irritability, insomnia, disinhibition
(loss of self-control), emotional lability (instability), akathisia
(agitation with hyperactivity), hostility, aggression, and mania.
Especially in people who are already depressed, these
over-stimulated reactions can lead to a severe worsening of depression
or to transformation of the depression into mania. These effects can
cause suicide and violence toward others.
After I described the risk of antidepressant-induced stimulation in
1991, I further developed the concept in subsequent books, including Talking Back to Prozac (1994), Brain-Disabling Treatments in Psychiatry (1997), Your Drug May Be Your Problem (1999, with David Cohen) and the Antidepressant Fact Book
(2001). I have also testified to the same principles in numerous
malpractice, product liability, and criminal cases involving
antidepressant-caused suicidality, violence, and varied severe abnormal
behaviors. Long before the FDA came around to agreeing with me, the
courts have found sufficient scientific merit to my arguments to allow
them to be expressed at trials, including product liability cases
against the manufacturers of these drugs. The vast majority of these
cases against drug companies were settled before going to trial.
Shortly before the FDA met in 2004 to consider
antidepressant-induced suicidality in children, I wrote a peer-reviewed
scientific article that was simultaneously published in Ethical Human Sciences and Services and the International Journal of Risk and Safety in Medicine (available on www.breggin.com).
My paper drew together all of the available scientific evidence that
the newer antidepressants cause a stimulant or activation syndrome that
can drive a person toward suicide or murder. I used scientific concepts
and language in this paper that were subsequently adopted by the FDA:
Mania with psychosis is the extreme end of a stimulant continuum
that often begins with lesser degrees of insomnia, nervousness,
anxiety, hyperactivity and irritability and then progresses toward more
severe agitation, aggression, and varying degrees of mania. (Breggin
2003/4, p. 32; obtainable on www.breggin.com).
I also discussed in detail the risk of akathisia (agitation with hyperactivity) as a cause of violence and suicide.
On March 22, 2004 the FDA published a Talk Paper entitled, "FDA
Issues Public Health Advisory on Cautions for the Use of
Antidepressants in Adults and Children." The advisory focused on adults as well as children and stated:
The agency is also advising that that these patients be observed for
certain behaviors that are known to be associated with these drugs,
such as anxiety, agitation, panic attacks, insomnia, irritability,
hostility, impulsivity, akathisia (severe restlessness), hypomania, and
This FDA statement is interchangeable with many that I have made in the literature and in the courtroom.
The FDA describes these adverse reactions as "known"—that is,
scientifically demonstrated or established. The list confirms the
existence of the antidepressant-induced stimulant effect or activation
syndrome in adults and children with its potential to cause hostility
and related behaviors. The FDA has gone on to require drug
manufacturers to include these antidepressant-induced adverse effects
in their FDA-approved labels for the drugs. The FDA label for
antidepressants (revised January 26, 2005) requires the following
statement about activation or stimulation in children and adults:
The following symptoms, anxiety, agitation, panic attacks, insomnia,
irritability, hostility, aggressiveness, impulsivity, akathisia
(psychomotor restlessness), hypomania, and mania have been reported in
adult and pediatric patients being treated with antidepressants for
major depressive disorder as well as other indications.
Simultaneously, the FDA compelled the drug companies to include a
specific warning about the increased risk of suicidality in children
taking antidepressants. This warning has received the most attention in
the media and the medical profession. However, FDA recognition of the
stimulant or activation syndrome, including the production of increased
agitation, irritability, impulsivity, hostility, aggressiveness, and
mania is in many ways more important. Over-stimulation is far more
common than suicidality and causes not only suicidality but also
violence and an endless variety of destructive, impulsive behaviors.
The adverse effects described by the FDA are almost identical to
mine, suggesting that they paid attention to my publications and to my
testimony before the agency on two occasions in 2004 (obtainable on www.breggin.com).
Also, the FDA’s has followed my method of organizing these specific
adverse effects into one group that can be viewed as stimulation or
activation. I have written in some detail about the implications of
recent regulatory changes in regard to antidepressants that have
occurred in the U.S., Canada and Great Britain.
The FDA has continued to affirm the points I first made in 1991 in Toxic Psychiatry.
On June 30, 2005, the FDA issued another Public Health Advisory, this
time aimed more specifically at adults, entitled, "Suicidality in
Adults Being Treated with Antidepressant Medications." The FDA
announced the beginning of a lengthy review of the subjected and in the
Adults being treated with antidepressant medications, particularly
those being treated for depression, should be watched closely for
worsening of depression and for increased suicidal thinking or behavior.
On July 1, 2005 the FDA issued an FDA Talk Paper on the same
subject. It emphasized another point that I have been making in my
books and articles, and in court, for many years:
Close observation of adults may be especially important when
antidepressant medications are started for the first time or when doses
for the specific drugs prescribed have been changed.
I have been consulted in dozens of malpractice and product
liability cases in which patients have committed suicide or perpetrated
violence against others shortly after starting antidepressants or
shortly after dose changes.
Naturally, it is gratifying to have the scientific literature and
the FDA confirm observations that I have made, at some professional
cost, for many years. It is satisfying to see views once labeled
radical and controversial become centerpieces of establishment drug
regulation. On the other hand, it is frustrating and even tragic that
there has been such a long delay in coming to grips with drug-induced
problems that have resulted in innumerable acts of suicide and
violence. Furthermore, medical professionals, especially my colleagues
in psychiatry, continue to resist and even to ignore the scientific
evidence and the warnings from the FDA. The FDA itself has shown no
willingness to take the next step—to ban these largely ineffective and
highly dangerous agents.