A small number of people taking fluoxetine have experienced intense,
violent, suicidal thoughts, agitation, and impulsivity. Whether their
symptoms were induced by fluoxetine or were related to their underlying
psychological problems is unclear. As with any other antidepressant,
fluoxetine should only be used under close medical supervision. Patients
are advised to consider telling relatives and friends about their use
of this drug and the risk of suicidal obsession and self-injurious
behavior.
On September 20, 1991, the FDA held a hearing to discuss a request
that warnings be placed upon the labels of Prozac and other antidepressants,
which was made by Ralph Nader's health research group, The Public Citizen.
They felt that problems were serious enough that warning labels mentioning
the possible side effects of "violence and suicide" should
be put on the bottle to make consumers more aware of the rapidly mounting
evidence that Prozac may chemically induce this reaction. Ten professionals
sat on the FDA board. Although the FDA had felt that the financial
interests held by these ten individuals would not sway their vote,
so they had them sign a statement that they would not allow that to
influence them. All five who admitted their interests at the beginning
of the FDA hearing voted "against" the warning label.
Fluoxetine and the other SSRIs may reduce the risk of suicide in depressed
patients. However, there have been a few reports that fluoxetine may
actually induce suicidal thoughts in selected patients, although this
has not been confirmed. Public Citizen's Health Research Group petitioned
the Food and Drug Administration in 1991 to require a box warning in
the professional product labeling for fluoxetine warning doctors that
a small minority of persons taking the drug have experienced intense,
violent, suicidal thoughts, agitation, and impulsivity after starting
treatment with the drug. You should not take this drug for mild depression
or anxiety, or as a sleeping pill.
Because of her suicidal and self destructive behavior her dosage of
Prozac was increased, and along with that increase came an increase
in suicidal ideation and self mutilation. Finally her doctor read Dr.
Tiecher's report, immediately called her and told her he felt her problem
was Prozac. She argued that she must "need" this antidepressant
because of her odd behavior. Then as the evidence became clear to her,
she asked, "You mean to tell me I have gone through this Hell
because of an anti-depressant?!!" Rhonda Hala went off Prozac
and returned to a normal mental and emotional state.
I continued to check in with Joanne daily. The suicidal preoccupation
subsided quickly and was completely gone within a week. Given what
had happened, Joanne did not want to try another antidepressant. I
wasn't feeling that bad before I started Prozac." Indeed, Joanne
did fine without medication.
"I became obsessed with death, with my sickness. I became obsessed
with the idea that I was a sick person who would have to be on antidepressants
all my life. I became obsessed with dying. I thought dying was the
only way out, and I had never contemplated suicide before that time. "
"Eli Lilly's staunch defense of Prozac"
Presumably Prozac's advocates were afraid any change in the prescribing
guidelines for antidepressants, even a general warning, would have
caused further public relations problems for the pharmaceutical industry.
Public fear was already running high. Prozac was alleged to be associated
with suicides, murders, murder-suicides, and even mass murder-suicides
like Joseph Wesbecker's shooting spree at Standard Gravure. Numerous
lawsuits had been filed in deaths associated with Prozac. Given how
high profile the issue had already been, any suggestion that antidepressants
could cause severe agitation that needed to be controlled with sedatives
would only raise more questions. Pharmaceutical companies spend hundreds
of millions of dollars developing and launching a drug like Prozac.
By 1991, Prozac was already the number-one best-selling antidepressant,
with sales near $1 billion a year. The stakes were indeed high. So
the pharmaceutical industry and drug advocates decided to defend
Prozac at all costs, despite the risks to individual and public safety.
Teicher and his colleagues went on to recommend that, "the practitioner
be attentive to the possible emergence of suicidal ideation, even in
those patients without a previous history of suicidal thoughts or actions.
Patients who have previously been treated with other antidepressants
or who develop intense fatigue, hypersomnia, or restlessness while
taking fluoxetine [Prozac] may be at risk."
Healy himself has continued to publish on the subject of suicidality
and violence associated with Prozac. He has published numerous articles
and several books, including a recent one on the Prozac-type antidepressants.
The antidepressant Era, published by Harvard University Press. In court
declarations, Healy reports Lilly has been guilty of "bald mischaracterization" of
his statements and work. Healy says Lilly's "refusal to mount
or countenance further investigation" of Prozac's causing suicide
and violence "must say something about their perceptions of what
the likely outcome would be."
Suicidality was more frequent among patients receiving Prozac than
among those receiving older, tricyclic antidepressants. "The relative
risk of suicidality was 3.3. Interestingly, the proportion of patients
with treatment-emergent suicidality on Prozac in this study was similar
to that reported by Teicher" in his original article calling attention
to the problem.
Although Prozac was reported to have fewer side effects than most
antidepressants, and this was the basis for the aggressive marketing
that has pushed Prozac to the top of the charts, the FDA lists approximately
575 side effects. Additionally, Lilly admitted to the FDA on April
20, 1990 that they did not include "suicidal thoughts" as
an adverse event and therefore, did not look for that as a side effect
in their clinical trials on Prozac.
In the mid-1980s, the German food and drug administration notified
Lilly that they were not going to approve Prozac "because of their
concern with suicidality and agitation," said Dr. Lord. She continued, "They
[the Germans] said that people became agitated before the antidepressant
effects came on, and that increased the risk of suicide. They wrote
a memo concerning damaging effects, and Lilly then went over there
and looked at the data again and pulled out cases that they didn't
think were suicide. How are they to know? The investigator [researcher]
thought it was a suicide attempt. They said, well we don't think it
is." Difficulties in other European countries were handled in
a similar way.
"Some research studies and government organizations have ties
to the pharmaceutical industry"
Britain's Dr. David Healy mentioned in a lecture at U of T that Prozac
may trigger suicide in some patients. This has raised a real stir among
scientists as Prozac's manufacturer, Eli Lilly, is an important private
donor to a mental-health research institute affiliated with the university.
One of the latest flaps in psychiatry circles that has spilled into
the public press, deals with the safety of the SSRIs. Occasional suicides
and violent behavior in children have led to calls by some to follow
the lead of the British equivalent of our FDA in banning all SSRIs
for children except Prozac, and early in February 2004 the FDA was
scheduled to hold hearings on the issue. Days before the hearing, a
group of researchers from the American College of Neuropsychopharmacology,
headed by two prominent academic psychiatrists, released a preliminary
analysis of their Task Force on SSRIs and Suicidal Behavior in Youth.
It concluded that antidepressants did not increase the suicide risk
in children, and that the benefits of SSRIs outweighed their risks.59
Their report was immediately criticized because nine of the ten panel
members allegedly had "extensive ties to the pharmaceutical industry."60
Some critics labeled their report "junk science"; others
were less restrained.61 At the hearing, FDA regulators testified that
their analysis did suggest that in clinical trials the risk of suicide
in children was increased over those taking placebos with some of the
SSRIs.62 So far, the FDA has decided only to require a warning about
possible suicide tendencies in descriptions of these drugs.
Had the FDA decided to add a warning on suicide and violence to the
label of antidepressants, this would have necessitated closer monitoring
of patients, markedly reducing Prozac's unique appeal for primary-care
clinicians.
All of these drugs by reducing 5HIAA serotonin levels should, therefore,
produce any or all of the listed behaviors associated with low 5HIAA
serotonin levels, ie: suicide, arson, violence, alcoholism, depression,
insomnia, impulsive behavior, etc. These are many of the symptoms which
patients are encouraged to take these drugs to alleviate. This has
been a most incredible deception. Whatever the reason for patients,
many physicians, the FDA, Congress, any of us, to have been kept in
dark about the critical similarity of these antidepressant drugs to
the psychedelic drugs and their potential to induce these behaviors
is absolutely inexcusable.