June 05, 2009

FDA Dubs Antipsychotics For Kids Effective With Substantial Risks

The FDA psychopharmacology advisory committee next week is slated to meet to evaluate safety and efficacy data for three atypical antipsychotics (Seroquel, Geodon and Zyprexa) for use in 13 to 17 year olds diagnosed with schizophrenia and with 10 to 17 year olds diagnosed with so-called pediatric bipolar disorder. The committee will then vote on what recommendations to make to the full agency on these drugs which have proven extremely problematic in adults

Today the FDA itself released its briefing package for committee members (note: the packages are huge and not recommended for download unless you have a technical need for them) and in his introduction FDA psychiatry products chief Thomas Laughren put it like this:

"Although the Division has not yet reached a final conclusion for these applications, we generally are in agreement that the sponsors have provided adequate support to suggest effectiveness for these products for the claimed indications. In addition the safety profiles for these products in these pediatric populations studied appear to be qualitatively similar to those observed with these drugs in adult patients....

"All of these drugs also have significant risks that must be considered, both by FDA in deciding whether or not to approve these claims and also by clinicians in deciding whether or not to use these medications in treating these serious disorders. Adverse reactions that can occur with drugs in the class of atypical antipsychotic drugs include, among others, somnolence, weight gain, increases in blood lipids and glucose, acute extrapyramidal symptoms, and tardive dyskinesia. These risks are of particular concern in pediatric patients because of the life-long nature of these disorders and the fact that these patients are considered particularly vulnerable, in part because they may be exposed for many decades, and in part because of possible effects on growth and development."

I have no idea where the committee will go with all of this, but you'd hope that if they recommend approval for either indication then they would do so with a plea that the agency order significant warnings be placed on the drugs for use in kids. There is simply so much weight gain in the Seroquel and Zyprexa packages to justify making parents, kids and doctors highly aware of the problem.

Posted by Philip Dawdy at June 5, 2009 09:58 AM
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For any parent new to Zyprexa, please take note that in 1999 this drug was given to my daughter off-label use at age 11 and she gained an immediate 100 lbs. The drug agitated her and caused aggression and also knocked her out, sleeping 12-14 hours a night. She is now 21 and her pre-teen years and teen years were completely changed being an overweight teen in high school, subject to bullies and mean words.

This antipsychotic in my opinion has no business being used in children, the safety has never been proven for use in children under age 18 long term use and my daughter, as a result of the 6 yrs and one last over medication by this drug in a psych ward has for all intent and purpose left her in one of her teacher's words in 2006 "she appears like a stroke victim".

Posted by: Stephany at June 5, 2009 05:13 PM

It's incredibly depressing to think of kids being given these drugs. I don't see psychiatrists in the field being more cautious just because their patients are children.

Big Pharma shoulders most of the blame, followed by the psychiatrists. But what about these parents that agree to this kind of treatment? I think after this collective madness subsides, we'll see this trend for what it is: child abuse.

Posted by: Francesca Allan at June 5, 2009 07:00 PM

I was 14 when I was forced to take this class of drugs against my will back when Dxing Bipolar in minors was still pretty new. I resented it. I hated the experience of it. The slurred speech and drooling. The memory gapping and fog. The feeling like no matter how much sleep I got my muscles were always weak and fatigued.

I got off them myself through deceiving my keepers. Once I was thinking clearly again it was not long before I learned about the mental health patient's bill of rights.

After a month of carefully concealing all symptoms I challenged the placement I was in and refused to ever take psychiatric meds again. I got my day in court and the judge agreed with me.

In the process I lost my faith and trust in the medical/psychiatric/psychological health care system. I knew that if I was ever going to find solace for my soul and inner equilibrium that I would have to seek it elsewhere.

As a ward of the State with a mental health label I was court ordered into monthly therapy for much of my remaining years as a teenager. I learned to lie to clinicians and I kept my mouth shut about how I was really feeling and what I was thinking about from then on.

For years afterward as an adult I tried to forget that it had ever happened to me. I did not always succeed. I never truly forgot about it and the psychic insult and spiritual indignity or the feelings of internal disgust at the presence of Trilafon in my body. The smell and taste of it lingered and the memory of it triggered anxiety attacks. In my ego and pride I did not think I deserved it. I did not think it was fair.

Years later when the flashbacks revisited I fantasized about doing horrible things to the people that put me on those drugs and the family members that allowed it to happen to me. I wanted revenge.

It took years of learning spiritual practices like meditation before I could release the memory demon and the ego injury of watching my mental and physical capabilities diminishing as the days and weeks went by during the six months I was on antipsychotics.

It took years before I developed the capacity to forgive myself for being helpless to prevent it from happening back then and forgive them for not knowing what they were doing.

In the final analysis being forced to take antipsychotics and the experience of living under the influence of that toxic substance became just another trauma I had to get over in addition to all the other stuff I had to work on.

It's one thing if you are an adult and you have some experience with critical thinking. You pay your money and you take your chances when you try out neuroleptics. Children and adolescents have no defense against this treatment.

They don't have that uniquely adult ability to bullshit themselves that these horrible side effects and feelings of disability and diminishment are just the magic of the medicine doing it's job for their own good.

When I made a video about my teen experiences on antipsychotics and put it on the internet I received public comments and private emails from teenagers from Europe, Canada and North and South America who told me that they too resented it and hated the experience and they did not know what they could do to make it stop. They suffer.

As minors they don't have anyone in Congress looking out for them. The kids in the US have no right to refuse this treatment until the age of 15 or 16 and most of these kids will not be told they have the option of refusal.

A child or a teenager does not have and can not have, truly informed consent. They can not weigh the risk to reward ratio in any meaningful way. Not only are minors not truly informed they are typically lied to by omission of interesting facts like the risks of tardives dyskinesia, akathasia and long term nervous system or glandular damage.

I had no idea what was going to happen to me or how horrible it was going to be. Of course had I known in advance, I daresay I would have fought with every fiber of my being or perhaps even tried to kill myself to escape it.

I ended up trying anyway, shortly before I learned that I had the legal right to refuse consent to medical treatment if I was not dangerously acting out.

Suicide became an attractive option when there seemed to be no way of escaping this never ending chemical violation that persisted like living in the endless borderland between limbo and hell.

To put a child or teen on these drugs is abuse and neglect that endangers the spiritual health and physical wellbeing of teens both short and long term. I can not denounce and condemn the danger of these poisons nor the horror of their side effects strongly enough.

Posted by: Jane at June 7, 2009 12:32 PM

To even diagnose children with schizophrenia or Bi-polar is bad enough, drugging them for it with these dubious chemicals is an absolute travesty and ultimately will result in tragedy later on in their lives. Of course.. Then the psychiatrists will just blame the "original condition" for whatever damage occurs.. They have it all sewn up don't they.. The masters of deception...

Horrible..

Posted by: truthman30 at June 7, 2009 01:56 PM

These comments above are reason for psychiatrists such as Joseph Biederman to be stopped. Biederman's influence is pure evil, no one can deny it.

My daughter researched medications she was given at age 11 by at age 17 and fired her psychiatrist. By then, she herself fell victim to the bipolar child dx, being highly influenced by her doctor.

Alongside her, I helped her battle and still am, the wrong dx that stole her life away via drugs.

Jane, as always I hear your story and know the fight you led to get where you are today. Many (let's say all) the kids in the teen unit my daughter (frankly was brainwashed to wanting to keep returning there, really)was inpatient with were wards of the state and foster kids, and several ended up in the adult system where I saw them again (sadly).

Soul and dignity are all we have and by God, I hope we can all keep them in tact after all of this. Yes, it affected me greatly too.

Maybe this doesn't belong in this thread, but then again drugging children on Zyprexa is reason to write it here.

Posted by: Stephany at June 7, 2009 07:00 PM

Jane,

Thanks for the beautifully written, moving account of drugging. It sickens my heart to think of the children being tortured as we speak by these drugs and dx's and as Stephany mentions, often brainwashed into believing they are getting help. And then as Truthman writes, the psychiatrists blame any damage on the "original condition" and most people are so shattered that the transition from adolescent "patient" to adult chronically mentally ill goes unremarked on and wanting to get better is a symptom to be extinguished. Scary stuff. I'm glad you fought and won.

Posted by: Sally at June 8, 2009 07:30 AM

Jane,

It's an interesting experience to have to lie to get free to get better. I don't think you could ever look at medicine or psychiatry the same way afterwards. We tend to have this view that doctors are caregivers, and there may have been a time when this was largely true. I think you'd be very fortunate today to find a physician or psychiatrist you could fully trust. Between record keeping, CYA, malpractice insurance, money, greed, influence peddling, and everything else, doctors have a lot on their plate even before you walk in the door. It's very hard to assess what you're getting yourself into until it's too late.

You're right. Young kids have no choice, no say, no control over their bodies or minds. Parents can be compromised, emotionally, for all the best of intentions. After all, you go in trusting a doctor is doing the right thing and knows what they are doing.

Without reform in medicine, psychiatry in particular, your story will be retold countless times with but a new name and face. I don't know how to fix this other than to keep the pressure on by telling others of our experiences. Hopefully, we can bring about the necessary change quickly.

Posted by: Paul at June 8, 2009 11:56 AM

Jane,
Thank you for sharing your story. I, too, have learned to lie and cover up with doctors. It's how I survived to get away from them. I will never trust another one of them again, not even the ones I actually like. Mostly, they don't know what the hell they're doing.
Sherry

Posted by: Sherry at June 8, 2009 04:19 PM

I just wanted to say thanks to everyone who read my comment and responded.

Posted by: Jane at June 9, 2009 07:20 AM
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