Fwd: [SSRI-Research] Report to the FDA: Observations on SSRI-Induced Behavioral and Mental Abnormalities in Children and Adults

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JustSayNo

Tue, 27 Jan 2004 00:01:27 -0500

[sSRI-Research] Report to the FDA: Observations on SSRI-Induced

Behavioral and Mental Abnormalities in Children and Adults

 

Peter R. Breggin M.D.

101 East State Street, No. 112

Ithaca, New York 14850

www.breggin.com

Phone 607 272 5328 Fax 607 272 5329

 

January 24, 2004

Report to the FDA:

 

Observations on SSRI-Induced Behavioral and Mental Abnormalities

 

in Children and Adults

 

When evaluating the vulnerability of children or adults to SSRI-induced adverse

drug reactions, the inquiry should be broadened from suicidality to include the

overall

problem of SSRI-induced mental and behavioral disturbances, such as manic-like

syndromes, agitated depression, agitation, anxiety, akathisia, and insomnia.

These

phenomena can be understood as a continuum of stimulant adverse effects that, in

their

extremes, result in manic psychoses with violence and agitated depressions with

suicide.

The overall pattern of SSRI-induced mental and behavior syndromes is

welldocumented

and should discourage their use in children. For example, in brief clinical

trials

involving children, rates of SSRI-induced mania run as high as 4-6% and rates

for SSRIinduced

depression as high as 5%. In actual clinical practice involving longer drug

exposures and less thorough monitoring, the rates are even higher (see the

enclosed

reviews).

 

Studies conducted with adults have grave implications for even more vulnerable

children. Many clinical reports, clinical trials and epidemiological studies

demonstrate

increased rates of abnormal behavior, especially suicide, in adults in

association with SSRIs.

In addition to several books*, I have addressed these issues in two recently

published peer-reviewed reports that are available on my website

(www.breggin.com):

(1) Breggin, P. " Suicidality, violence and mania caused by selective serotonin

reuptake inhibitors (SSRIs): A review and analysis. " International Journal of

Risk &

Safety in Medicine, 16, 31-49, 2003/4.

 

Two sections focus on children (pp. 40-42) and review clinical case studies,

clinical trials, and epidemiological studies indicating significant rates of

suicidality and other behavioral abnormalities. The paper reviews the

literature and describes the SSRI-induced clinical syndromes that are

associated with abnormal behaviors.

 

(2) Breggin, P. " Fluvoxamine as a cause of stimulation, mania, and aggression

with

a critical analysis of the FDA-approved label. " International Journal of Risk

and

Safety in Medicine, 14: 71-86, 2002.

 

SSRI-Induced Behaviors, p. 2

 

Based on data collated from the FDA-approved label, including clinical trial

data, Table I (p. 81) shows the unusually high rates of depression and other

adverse reactions in children.

 

The above two reports were written specifically to address the kinds of issues

that

the panel will be examining. The scientific literature is much more extensive

than generally

realized and the syndromes rather well-documented and defined.

 

My clinical and forensic experiences and the scientific literature indicate that

four

syndromes encompass most of the phenomena and describe most of the individual

cases:

 

(1) The production 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.

Mania or manic-like symptoms include disinhibition, grandiosity, sleep

disturbances, and out-of-control aggressive behavior, including cycling into

depression and suicidality.

 

(2) The production of a combined state of stimulation and depression-an

agitated depression-with a high risk of suicide and violence. Often the overall

depression is markedly worsened.

 

(3) The production of obsessive preoccupations with aggression against self

or others, often accompanied by a worsening of any pre-existing depression.

 

(4) The production of akathisia, an inner agitation or jitteriness that is

usually (but not always) accompanied by an inability to stop moving. It is

sometimes described as psychomotor agitation or restless leg syndrome. The state

causes heightened irritability and frustration with aggression against self or

others,

and often a generally worsening of the mental condition.

 

The above syndromes often appear in combination with each other. Obsessive

preoccupations in particular are often displayed by the individual. Again based

on my

clinical experience and the scientific literature, these characteristics

include:

 

1. A relatively sudden onset and rapid escalation of the compulsive

aggression against self and/or others.

 

2. A recent (typically within two months) initial exposure to the medication,

or a recent change in the dose of the medication, or a recent addition or

removal of

another psychoactive substance to the regimen.

 

3. The presence of other adverse drug reactions, often involving akathisia or

stimulation along a continuum from irritability and agitation to agitated

depression

and mania.

 

4. Resolution of the syndrome after termination of the causative medication,

often with a marked overall improvement in the individual's mental status.

 

5. An extremely violent and/or bizarre quality to the thoughts and actions.

SSRI-Induced Behaviors, p. 3

 

6. An obsessive, compelling, unrelenting quality to the thoughts and actions.

 

7. An out-of-character quality for the individual as determined by the

individual's history.

 

8. An alien or ego-dystonic quality as determined by the individual's

subjective report.

 

Often the medications have been prescribed without sufficient monitoring and

without the provision of adequate warnings to the patient and family about the

risks of

psychiatric adverse drug reactions.

 

Sometimes the syndromes will abate within days after stopping the SSRI but at

other

times they persist, leading to hospitalization and additional treatment over

subsequent weeks

or months. Reported rates for these four syndromes very widely but each of them

appears to

be relatively common. They frequently occur in individuals with no prior history

of

violence, suicidality, psychomotor agitation, or manic-like symptoms.

 

As a clinician and as a medical expert, I have been involved in dozens of

criminal,

malpractice, and product liability cases in which adults and children have

committed violent

and suicidal acts while taking SSRIs. In light of the scientific literature, the

courts are

giving more consideration to the role of SSRIs in producing abnormal mental

states and

behavior. When the patient is not informed in advance about the potential

impairment of

mental function and disinhibition of behavior, or when the prescription of the

medication is

negligent, the condition often qualifies as an involuntary intoxication under

the law. The

diagnosis in most cases is SSRI-induced mood disorder with manic features

(292.84).

The medical profession and the public needs to be made more aware of the mental

and behavior risks associated with SSRIs.

 

Peter R. Breggin, M.D.

 

*Talking Back to Prozac (St. Martins, 1994), Brain-Disabling Treatments in

Psychiatry

(Springer, 1997), and the Antidepressant Fact Book (Perseus, 2001).