Dr. Peter Breggin: FDA Continues to Confirm Antidepressant Risks I First Identif

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Dr. Peter Breggin: FDA Continues to Confirm Antidepressant Risks I

First Identified More Than a Decade Ago

 

 

 

Dr. Peter Breggin Mon Jul 4, 8:05 PM ET

 

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 FDA 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 following points:

 

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 mania. "

 

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 meanwhile warned:

 

" 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.