here's some scary stuff, re: medication, suicide & viole

Submitted by an LD OnLine user on

FDA reviews labels on antidepressants
Date: Sun, 21 Mar 2004 11:27:21 EST

http://seattletimes.nwsource.com/html/nationworld/2001884666_depress21
.html

Sunday, March 21, 2004 - Page updated at 12:00 A.M.

FDA reviews labels on antidepressants

By Elizabeth Shogren
Los Angeles Times

A popular honors student who played on his varsity high-school basketball and baseball teams in rural Washington state, Corey Baadsgaard nevertheless would come home complaining that no one liked him. His family physician prescribed Paxil, a popular antidepressant.
But Baadsgaard, then 16, sunk deeper into depression. The doctor switched him to a different antidepressant, Effexor, and stepped up
the dose over a three-week period from 40 milligrams to 300. The first morning Baadsgaard took 300 milligrams, he felt rotten and went
back to bed.

Three years later, he says, he still has no memory of what happened next: no memory of taking a high-powered rifle into his English class in Mattawa, 50 miles southwest of Moses Lake in Grant County, of herding his classmates and teacher into a corner, of holding them at
gunpoint for 45 minutes, of being talked by the principal into giving up his gun.

He spent 14 months in a juvenile detention center.

Baadsgaard and his father think the antidepressants made him suicidal at first, then violent. The Food and Drug Administration (FDA - based on such anecdotal evidence and results of clinical trials - is reconsidering its decision not to require that doctors and parents be
warned about possible side effects of the drugs known as serotonin reuptake inhibitors.

The link to suicide was the focus of an FDA advisory committee meeting last month. But testimony from Baadsgaard and others who had
turned violent while taking the drugs suggested to several committee members that the FDA should look more broadly into the medications’ adverse effects.

Dr. Joseph Glenmullen, a Harvard Medical School psychiatrist who has studied serotonin reuptake inhibitors, wonders whether antidepressants could help explain the rash of school shootings and
murder-suicides in the past decade.

People who take antidepressants, he said, could “become very distraught … They feel like jumping out of their skin. The irritability and impulsivity can make people suicidal or homicidal.”

Added Dr. David Healy, director of the North Wales Department of Psychological Medicine: “What is very, very clear is that people do become hostile on the drugs.”

Glenmullen and Healy stressed that parents, patients and doctors must be warned to look for potentially dangerous reactions. However, both
said they planned to continue prescribing the drugs.

Pharmaceutical companies and many doctors dispute the suggestion that antidepressants play a role in violent or suicidal acts.

Dr. Alastair Benbow, the European medical director for GlaxoSmithKline, Paxil’s manufacturer, refused to comment on specific
cases. But, he said, “I don’t believe there is any clear evidence that Paxil is linked with suicide, violence or aggression — and
certainly not homicide.”

The source of aggressive behavior, doctors and mental-health groups said, may lie with the illness and not the treatment. And failing to
treat depression, they said, could have costs as grave as treating it.

“Suicide and violence are well-recognized outcomes of depression itself,” Benbow said.

Although only one antidepressant, Prozac, is explicitly approved by the FDA for children, doctors prescribe others to young patients.
Most of the drugs carry no specific warnings about increasing the risk of suicide or violence.

However, one company, Madison, N.J.-based Wyeth, warned doctors in a letter last summer that children taking Effexor in clinical trials
had shown increased hostility and suicidal tendencies compared to children taking placebos. The company directed doctors not to prescribe Effexor to children.

And GlaxoSmithKline, during clinical tests on children with obsessive-compulsive disorder or depression, found that the percentage of
children taking Paxil who became hostile - which was defined as everything from angry thoughts to violent acts - ranged from 6.3 to 9.2 percent. For those taking the placebo, the range was zero to 1 percent, according to published records.

In Baadsgaard’s case, the violent outburst was completely out of character, said his father, Jay Baadsgaard. Corey never got into fights, his father said. In their family, he was the “hugger.”

So, “as soon as it happened, we knew the drugs had to have something to do with it,” Jay Baadsgaard said. Corey stopped taking the drugs
while in juvenile detention, and has not had any behavioral problems since, his father said.

Seattle Times staff contributed to this report.
– End forwarded message –

Submitted by Dad on Mon, 03/29/2004 - 11:20 PM

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Kitty -

I can tell that this issue is distressing to you, and I will not reply any more to it. I am sorry to have upset you in this manner. I believe I have said repeatedly that I am not laying blame on any person for a potential problem that is bigger than one person’s ability to influence, especially when they are struggling with a problem as overwhelming as depression, extreme anxiety or PTSD. I am not sure why you feel that I am attacking you personally. As you have said, your children have no apparent neurological problems which would fall under the question I posed originally. My question concerns those children who fall within the apparant growth bubble of BD and LD, a rise in incidence which I do not believe is adequately explained by “better recognition” or other dismissals. We have yet to determine etiology of a number of conditions and disorders. I do not think that we should omit sedatives and SSRI’s simply because it is inconvenient for them to be culpable.

No I do not think that this issue is black and white. For the most part it seems mostly a muddy grey. As you pointed out, there is a dearth of information on the topic of neurologically complications in children who were exposed to SSRI’s or benzos in utero. That means either it has not been examined, or if it has, the study has been rpressed. Getting back to the origin of this thread (had to stop and think for a minute what it was), the pharmas were caught suppressing negative findings regarding the use of SSRI’s in teens, and they have also been caught in the past suppressing other studies concerning a myriad of medications. That is why I feel we need to take those who will profit from the product out of the process of designing, implimenting and publishing medical testing studies.

The FDA has a semi-shoddy record as well. They have missed a number of things that they really should have caught, and yet will focus with great effort on other items which may not be entirely in their arena (and which sometimes are more in the interest of the companies they are suppost to be regulating).

I do not believe that I have ever once suggested that you or anyone else have an abortion. I have a very definate opinion on that issue, one which has gotten me into some rather “interesting” exchanges with people who do feel as strongly as I do about the beginning of life or the rights of the unborn.

I will say that I do not feel that pointing out that a small risk for one can become a more significant problem for the herd is dangerous ground however. We vaccinate for rubella for instance, a very benign childhood disease that had an almost non-existant mortality rate, because it was responsible for several thousand cases of congenital blindness, deafness, and MR, a risk of less than 2 tenths of 1%.

Again, I am sorry to have needlessly pushed your buttons, as always it was not my intent. I will not be replying to this topic again. I wish you luck Kitty and hope that you find what it is that you are needing to answer your own questions.

Submitted by Anonymous on Thu, 04/01/2004 - 2:16 PM

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This is good, and fairly RECENT. It’s a PDF file, hope it can be accessed.

http://collection.nlc-bnc.ca/100/201/300/cdn_medical_association/jpn/vol-26/issue-1/pdf/pg44.pdf

Submitted by Anonymous on Fri, 04/02/2004 - 2:26 AM

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Hi Rosalia,

Great article! Thanks for the link. As a friendly tip, it works better for me to download PDF files to my computer and open them from there. My browsers don’t seem to my like it too much when I open PDF links on line even though I have plenty of RAM.

The study followed 37 women who discontinued their psychiatric medicine during pregnancy. It was a combination of their fears and the physicians’ advice that led to this.

Paxil was the most widely used antidepressant as about 33% of the women had been using it. Prozac was the next most commonly used med at 16%

First of all, in light of what we have been talking about regarding risk, I thought these statistics were interesting.

Two babies had mild withdrawal symptoms that didn’t require medical intervention. One mother had been taking paxil and another amitriptyline. This comes out to a 6% risk rate compared to an average 1% to 3% rate for people who don’t take meds.

As an FYI, the 1% to 3% rate is official while I figured out the 6% rate on my own. I don’t know how that correlates with more extensive studies but I wanted to throw that out there. The other babies had no difficulties.

No matter what your viewpoint is, consider this next set of statistics. 11 out of the 37 women had suicidal ideation and four had to be admitted to the hospital. Fortunately, none of the women followed
through, but 4 had to be admitted to hospital. Because of the fear of teratogenicity, combined with the effects of abrupt discontinuation, 1 woman terminated an otherwise wanted pregnancy and another considered it, but did not follow through;.

Six of the 11 suicidal women were taking Paxil. The women who were taking Paxil reported the most serious side effects. That is not surprising to me since Paxil from what I understand is one of the worst drugs to withdraw from due to its very short half life.

The other women did have adverse side effects even though they were on other meds besides Paxil.
Even the few women who tapered off the medicine slowly still had problems.

I don’t know folks, if I was on psych meds and pregnant, it seems to me there is allot more risk in going off the meds than staying on them. Unfortunately, there doesn’t seem to be very many experts to advise these poor women. Dr. Valerie Raskin was sure right about that.

Obviously, if the women decided to go off the meds, that would be their choice. But I wonder if they made that choice with all the options in front of them or where they subtly pressured by their doctors?

Anyway, this article should be required reading of every doctor.

PT

Submitted by Anonymous on Fri, 04/02/2004 - 4:37 AM

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To Kitty, no need to thank me, it was my pleasure to post that article. It was no easy task locating it though, which makes me somewhat uneasy.

I also have trouble opening PDF files, but have no clue why. I thank you, PT, for translating the article into plain English for us.

Yes, PT, that article SHOULD be required reading of every doctor, and I applaud you for having the courage to state that in print. Especially psychs, and even more importantly, OB/GYNs. I suspect that not many doctors are as savvy and knowledgeable as Kitty says hers was.

So many doctors are misinformed or paranoid, or both, as are the lay people who feel the need to sit in judgement of these women, when they are also in fact misinformed, or worse yet, uninformed. Frightening indeed.

Because a woman has a debilitating illness such as chronic depression, an anxiety disorder, panic attacks, OCD’s, seizures (often a benzodiazepine such as Clonopazm will be prescribed for epilepsy, along with something else) or some combination of all, and she MUST take medication for it or become seriously ill, and that medication effectively controls her condition, does that mean she should never have the chance to be a mother? To experience the joy of bringing a child into her life? When, as per this article, the chance of birth defects are practically non-existent?

Submitted by Anonymous on Wed, 05/26/2004 - 12:35 PM

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For those who don’t know what one of the posters on this thread was referring to by her newborn baby’s “Apgar Score”, which she says was a 10/10 for her first child, and a 9/10 for her second child:

The APGAR Test
Your Baby’s First Assessment

By Genevieve Richards

Soon after your baby has made her entrance into the world and been placed on your chest for the much awaited face-to-face introduction, she will be whisked away by the nurse or midwife for a series of quick and thorough tests, to make sure she has come through the birth process safely.

The series, known as the APGAR test, is carried out at one minute and again at five minutes after birth, and is designed to assess a baby’s health quickly. According to American Pregnancy Association literature, “The one minute APGAR assessment reveals information about the baby’s physical health in the first minute after birth, helping the doctor decide if immediate or future medical treatment will be necessary. The five minute assessment measures how the baby has responded to any resuscitation attempts.”

The APGAR test was developed in 1952 by anaesthesiologist Dr. Virginia Apgar, who wanted a system for quickly and accurately assessing a baby’s health in the crucial minutes after birth. Before the publication of this newborn scoring system, many internal problems at birth, such as circulatory or breathing difficulties, were missed by doctors because it was usually assumed that a newborn baby was healthy, unless there was an obvious sign that something was wrong.

The APGAR newborn scoring system is based on five criteria that parents can remember using the acronym APGAR:

Appearance: refers to the color of the baby’s skin tone, depending on his circulation
Pulse: relates to baby’s heart rate which measures the strength and regularity of the heartbeat
Grimace (reflex): tests the baby’s reflexes and response when the sole of the foot is stimulated
Activity: gives an indication of the baby’s muscle tone
Respiration: reveals the maturity and health of the baby’s lungs.
Each element is given a score of zero, one, or two to provide a total score out of ten.

The APGAR newborn scoring system

Score 0 1 2

Appearance: 0/baby is completely blue or pale— 1/baby’s body is pink with blue extremities— 2/baby has good color
Pulse: 0/not detectable fewer than one hundred beats per minute—1/baby is not very responsive more than one hundred beats per minute—2/baby is vigorous
Grimace: 0/no response when the sole of the foot is stimulated— 1/baby grimaces when the sole of the foot is stimulated— 2/baby cries when the sole of the foot is stimulated
Activity: 0/baby is limp— 1/baby shows some muscle flexing in the feet and hands— 2/baby is active and can flex the hand and foot muscles
Respiration: 0/none— 1/baby has a weak cry and can’t seem to get enough air into the lungs— 2/baby is breathing well and can cry strongly

What do the scores mean?

A perfect APGAR score of ten means an infant is in the best possible condition. “Very few midwives will give ten for the first assessment at one minute because there is always a degree of the circulation adjusting,” says independent midwife Clare Winter. According to the American Pregnancy Association, a one-minute score of between seven and ten indicates that the baby will need only routine post-delivery care, while scores between four and six indicate assistance may be required for breathing. Scores under four may call for prompt lifesaving measures.

At the five-minute mark, a score of seven to ten is normal. If the score falls below seven, the baby will continue to be monitored and evaluated. A persistently low score gives doctors a warning signal that they should check the baby for hidden health problems, such as breathing difficulties or internal bleeding, and allows them to give the baby crucial medical attention when it is most needed.

While the APGAR score is helpful in assessing baby’s health, it does have limits. Parents should keep in mind that lower than normal scores do not mean there will be permanent problems for the baby, nor does the score predict baby’s future intellect, temperament, or physical capabilities.

How do I find out my baby’s APGAR score?
Whether the APGAR score is revealed to parents or not may depend on both the hospital’s policy and country in which the baby is born. In many countries, parents are not told their infant’s APGAR score unless they ask, while in others—such as New Zealand—parents are always told the score and it is part of the documentation new parents receive with their child’s health information. Parents can include learning the APGAR score in their birth plans and/or ask the doctor or midwife for the information after delivery.

Submitted by Anonymous on Wed, 05/26/2004 - 7:54 PM

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The reason I happen to know what the Apgar scores were, at both birth and at 5 minutes, for both of my children, is because I ASKED the doctor, right there in the delivery room.

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