- SSRI Antidepressants & Homicide: "Hard data
that SSRIs cause mania & manic episodes are frequently accompanied
by violence:" quote by Richard Kapit, a retired FDA scientist
- Paragraphs 18 through 21 state: "Dr. Richard Kapit,
a retired FDA scientist who reviewed Prozac, Paxil and Zoloft in the late
1980s before the antidepressants were approved to treat depression in adults,
said that he suspected the drugs could cause people to become suicidal
or homicidal from the beginning. Those risks, however, did not outweigh
the potential benefits of the drugs, he said.
-
- "I had always thought the drugs had the potential
to cause manic episodes, and manic episodes are frequently accompanied
by violence," said Kapit, who will testify for the defense at Pittman's
trial. "When I reviewed Prozac in the 1980s, I accepted that in rare
patients it could cause patients to become manic, suicidal. I don't think
I doubted, or anyone doubted, in rare patients that could be true.
-
- "Now we have hard data to back up what everyone
sort of believed, that these drugs are capable of causing manic states."
-
- Of the 24 antidepressant clinical trials involving juveniles
reviewed by the FDA, 22 failed to show the drugs were any more effective
than a placebo"
-
- http://www.heraldonline.com/local/story/4115379p-3882366c.html
-
-
- Depression drugs to be distributed with warning
label
- FDA says 'black box' should warn of dangers
for children
-
- By Jason Cato The Herald
- (Published October 16, 2004)
-
- Antidepressants will now come with double-barrel warnings
meant to get the attention of doctors and parents: These drugs can and
do cause some children to become suicidal.
-
- The U.S. Food and Drug Administration on Friday acted
on a month-old recommendation from its own expert panel and will require
"black box" warnings for all antidepressants.
-
- A black box warning is the government's strongest safety
alert. It's one step below a ban.
-
- The label warnings will stress the importance of closely
monitoring children and adolescent patients started on these drugs for
the emergence of suicidal thoughts or behavior.
-
- That message also will come in the form of a medical
guide that pharmacists will be required to give patients with all antidepressant
prescriptions. The guide will be required to be distributed with sample
packets.
-
- Impact on Pittman case
-
- Critics who've long fought for such warnings, including
attorneys for a boy facing double murder charges in Chester County, called
Friday's actions a step in the right direction. Still, many questioned
what took the FDA so long to act.
-
- "It's taken far too long, but I'm thrilled by it,"
said Karen Barth Menzies, an attorney from Los Angeles who represents Christopher
Pittman, the boy charged with killing his grandparents at their Chester
County home in 2001. "People have just been buying the idea for so
long that these drugs are good for anything and everything. We now know
that isn't true. But it's just another example of the FDA failing to act
sooner."
-
- Dr. Lester Crawford, the FDA's acting commissioner, said
in a written statement that Friday's actions "represent FDA's conclusions
about the increased risk of suicidal thoughts and the necessary actions
for physicians prescribing these antidepressant drugs and for the children
and adolescents taking them."
-
- "Our conclusions are based on the latest and best
science," Crawford said.
-
- The American Academy of Pediatrics applauded the FDA's
decision.
-
- "Pediatricians support stronger warnings, including
the black box, as we now know there is definitely an increased risk of
suicidal thinking and behavior in children who are on these drugs. The
labels needed to change," said AAP President Dr. Carol Berkowitz in
a written statement "However, we still believe that for the most serious
cases of depression or other psychiatric disorders, these medications can
help adolescents following appropriate diagnosis, an explanation of the
risks and benefits to the patient and family, and specific guidelines for
monitoring."
-
- An official with GlaxoSmithKline, the British drug giant
that makes the antidepressant Paxil, told the Associated Press that the
company sees the warnings as a positive action.
-
- "We agree with the FDA that providing additional
information to everyone -- from health care professionals to parents and
patients -- is one of the most positive steps that can be taken to advance
the diagnoses and treatment of adolescents with depression," said
Mary Anne Rhyne from the company's office in Raleigh, N.C.
-
- The end result left victims, scientists and advocates
giddy with happiness and claiming victory, but many strongly disagreed
with Crawford's assertion that the actions were based on the latest and
best science.
-
- "The FDA fought every step along the way until they
couldn't hold out any longer," said Vera Hassner Sharav of the Alliance
for Human Research Protection. "I see this as a victory, but the antidepressant
issue is a demonstration of how the system is dysfunctional."
-
- The British government in December, using the same clinical
trial data provided to the FDA, all but banned antidepressants from being
used with children. In the 10 months since, the FDA has held two advisory
panel meetings to explore the issue of antidepressants in children, including
one in September that led to the black box warning recommendation; a Congressional
investigation subcommittee has held two hearings looking into what the
FDA knew about the dangers of antidepressants and when; and the New York
attorney general sued Glaxo for withholding data from clinical trials that
demonstrated its drug was either dangerous or not effective in treating
depression in children.
-
- Questions about the safety of antidepressants first arose
in the early 1990s, just years after Prozac, the first of the antidepressant
"wonder drugs" known as selective serotonin reuptake inhibitors,
was approved. An FDA hearing in 1991 concluded that no credible evidence
existed to show Prozac could lead adult patients to become suicidal or
homicidal.
-
- Dr. Richard Kapit, a retired FDA scientist who reviewed
Prozac, Paxil and Zoloft in the late 1980s before the antidepressants were
approved to treat depression in adults, said that he suspected the drugs
could cause people to become suicidal or homicidal from the beginning.
Those risks, however, did not outweigh the potential benefits of the drugs,
he said.
-
- "I had always thought the drugs had the potential
to cause manic episodes, and manic episodes are frequently accompanied
by violence," said Kapit, who will testify for the defense at Pittman's
trial. "When I reviewed Prozac in the 1980s, I accepted that in rare
patients it could cause patients to become manic, suicidal. I don't think
I doubted, or anyone doubted, in rare patients that could be true.
-
- "Now we have hard data to back up what everyone
sort of believed, that these drugs are capable of causing manic states."
-
- Of the 24 antidepressant clinical trials involving juveniles
reviewed by the FDA, 22 failed to show the drugs were any more effective
than a placebo. A review of the same trials by a Columbia University team
hired by the FDA also showed that antidepressants can cause 2 percent to
3 percent of young patients who were not suicidal before taking the drugs
to become so during the early stages of treatment.
-
- Only Prozac has been approved by the FDA to treat depression
in children. It was also the only drug not to be included in the British
government's virtual ban.
-
- However, all antidepressants are given to children through
a legal practice known as "off-label" prescribing. Last year,
more than 11 million antidepressant prescriptions were written for U.S.
children, according to the FDA. A recent study showed as many as 89 percent
of those were written for off-label, or non-approved, uses.
-
- "In other words, almost 90 percent of the time children
receive antidepressants that are not approved by the FDA for that child's
condition," said Dr. Joseph Glenmullen, a psychiatrist at Harvard
University. "To give a child a drug that can make them suicidal for
conditions where there is nonexistent or inadequate proof that the drugs
work is irresponsible and fails to protect our children.
-
- "Surely, the FDA and the pharmaceutical industry
know that even a black box warning will not adequately curtail prescribing
unapproved antidepressants to children for unapproved conditions."
-
- Glenmullen, who prescribes antidepressants, said the
FDA should have banned doctors from prescribing the drugs for non-approved
uses. He also said the FDA still has much work to do on the antidepressant
issue.
-
- Left to be explored, he said, is whether the drugs can
cause adults to become suicidal and the role the drugs play in causing
people to become violent and/or homicidal.
-
- "And that goes right to the Christopher Pittman
case," Glenmullen said.
-
- Pittman is charged with shooting Joe Frank Pittman and
Joy Roberts Pittman while they were in bed in November 2001 before setting
the house on fire and fleeing in a family vehicle. He was 12. Now 15, Pittman
will be tried as an adult and could be sentenced to life in prison if convicted.
A trial date has not been set.
-
- The boy had been on a five-week regimen of Paxil and
Zoloft. His attorneys will contend an adverse reaction to his antidepressant
medication caused his violent behavior. Friday's move by the FDA strengthens
that position, they said.
-
- "We know it's been established that Zoloft causes
kids to commit suicide," said Andy Vickery, a Houston attorney representing
Pittman. "It's not a big leap to homicide. It's the other side of
the same coin. It's caused by the same biological mechanism."
-
- Vickery said he is encouraged by the FDA's action but
wondered whether things would have been different had the warnings come
three years ago.
-
- "That would have been before Christopher got Zoloft
from a general practitioner for an unapproved use," he said. "Two
things might have happened. The doctor may not have given it to him, or
he might have provided them with the appropriate warnings."
-
- jcato@heraldonline.com
-
- Ann Blake Tracy, PhD
- Executive Director
- International Coalition For Drug Awareness
-
- Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare
-
- And the critically-important Audio tape
- detailing how to safely withdraw from SSRIs:
-
- "Help! I Can't Get Off My Antidepressant!"
-
- Order Number: 800 280-0730
-
- www.drugawareness.org
- Office: 801 282-5282
- Cell: 801 209-1800
-
-
- Comment
From Pat in Pennsylvania
10-17-4
-
- Hello, Jeff. At fifty years of age, I can hardly be
considered a child. But I can tell you some things about these SSRIs from
personal experience.
-
- Most importantly, in light of recent news, I refer to
ZOLOFT. I had been taking it for some time previously, but circumstances
brought about a rather nasty depression. So, I began taking it again.
And I "watched" myself behave in ways foreign to me. I saw that
I was becoming easily and quickly agitated, and that I had become very
aggressive (which was totally foreign to my personality). I was angrily
confronting college professors in my classes, bringing embarassment to
them, and lowered grades to myself.
-
- Another side-effect that is seldom mentioned is a feeling
like your whole body is receiving a brief electric shock. I have been
completely off of any SSRIs for about four years now, yet I still (less
and less frequently) experience this sensation.
-
- I had read a study that showed that some brain cells
take on a spiral shape which is abnormal. No long-term studies were ever
done to determine if these cells can return to their normal shape.
-
- It is definitely *not* just children who can be adversely
effected by these drugs. The *cure* can sometimes be worse than the illness
itself.
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