FDA Approves Antipsychotic for Bipolar Kids: What Does It Mean?

I actually believe the words could be "dangerous chemical" was approved for use in kids, that has already been used in kids off-label for OCD since 1999 would be appropriate for a title.Read the rest of my thoughts re: this on my blog. <a href="http://bipolarsoupkitchen-stephany.blogspot.com/2007/08/powerful-chemicals-what-do-they-do-to.html">Ex Bipolar Child</a>
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Dear John:

 

Long time no talk.  I have been busy working 12-hour days at my job.

 

I am confused about what you really think about antipsychotic meds for people (or children, specifically).  In one sentence you call the drugs "stupid", yet in another you are defending them by saying we should not use the word "powerful" because it implies something bad.  Which is it:  stupid or acceptable?

 

As a person who takes Risperdal, I know from personal experience that it is a "powerful" drug.  It pretty much single-handedly took care of my dire agitation when in a manic episode.  It also made me groggy and unable to concentrate.  Still, this was a small price to pay to be agitation free.

 

I am speaking from an adult perspective, when I tell you this.  If an adult has such a reaction, I can only imagine what a child's body would experience.  Kids are still growing and we don't really know if the drugs affect their growth or not (both of their brains and their bodies).  My nephew has ADHD and he took many "powerful" medications to manage his symptoms.  Today, he is a man of very short stature, and my mom and I can't help but wonder if some of the medications he took stunted his growth.

 

For any child, the uncertainty of how these "powerful" medications will affect them is quite scary.  I was told to give my son medications because he was depressed, irritable and non-compliant to my expectations of him.

 

  Well, of course he was depressed!  His mom was still an avid drinker and his father had just died.  He didn't need medication to "treat" his "symptoms". He needed supportive, loving friends and family, with whom he could spend time and share his feelings.  If I had agreed to the drugs, I believe it would have masked the underlying truth behind his depression and he might not have had the opportunity to live through his pain and survive it.

 

I've noticed that you are particularly fond of bi-polar moms.  You didn't say anything about bi-polar dads.  Are they not as knowing and understanding as their female counterparts?  It sounds to me like you have been getting really cozy with the NAMI folks, although you didn't include the dads as part of your group of favorite people.  What IS it about those moms?

 

So which is it, John - are the antipsychotic drugs good for kids or are they something else?  In my opinion, any kind of medication you put into a kid's body is "powerful".  The medical community and the "national mental health "consumer's" movement have clearly bought into the notion that kids need to be medicated to keep their behaviors under control. 

 

Why should drugs be one of the first options we consider?  Why not put them last in line, only to be used as a last resort.  A mom can take her hyper kid into just about any doctor, and he will give her a prescription for a "powerful drug".  This scares the bejesus out of me.  We just don't know how those drugs are interacting with our kids' growing bodies and brains. 

 

One other thing,  John - you need not tell me that I am welcome to feel safe on this forum.  And for those of you who are so ardently defending John, please, I am sure that John is capable of defending himself, bipolar or not.  And no, John, I do not feel ganged up by those of you who are singing in harmony.  I am somewhat amused by the following you have created for yourself.  For people to chastise me for simply sharing my opinion about what you are doing or not doing, is rather like a kid in a "clique".  Everyone rushes to the hero's side and defends him.  That is fine.  Frankly, I do not want to join a group of people who have bipolar, anymore than I want to joing a group of recovering alcoholics.  It just reminds me every day of what I have experienced before and, in many ways, keeps me from progressing forward.  To sit and ruminate, every day, about my past days of heavy drinking or manic/depressive episodes is to ensure that I have it on my mind all the time.  I would much rather spend my time with a more eclectic group of people who have more things on their minds than primarily bipolar disorder.  I have been there, done that.  While I may have some friends who happen to have bipolar, I do not care to make my entire social circle one of people with bipolar or who have an interest in bipolar.  I prefer a more varied group of people.

 

No, John, I was simply playing the devil's advocate to your hero.  While I am thrilled that you have fallen seven times and gotten up eight, and that you are no longer homeless and that you have gotten through your divorce, I am not into hero worship.  For as surely as I worship the hero, he or she fails to meet my expectations or, worse, he or she crashes and becomes a very vulnerable, frightened person once again.  I have found it very disheartening to idolize people, as they have inevitably let me down.  Some would say that the expectations placed on the hero figure are just too much for that person to bear.

 

I have done pretty much everything you have done (from what you have told me or expressed on this forum), with the exception of writing a book, and that is down the road a bit.  I have had people look up to me and admire me.  In the end, though, it was all for naught, if I didn't admire and respect myself.  And as much as I would have thought I could do that, with all those people singing my praises, it boiled down to how I felt about myself when I was alone in bed at night, with no one else but me and my higher power

 

I hope you enjoy your position for all that you can get out of it.  It is actually very flattering to have so many people look up to you, to defend you, and to admire you.  I hope it lasts a lifetime.  You have been through hell and back and you certainly deserve the best that life can offer you.

 

In the meantime, if I ever do decide that I want to re-join the national mental health "consumer's" movement, I will find a way, all by myself, to make that happen. I do not need anyone's assistance to do that.  I was merely speaking for the people who won't speak for themselves, hypothetically.  For now, I am content to live my life with my son, my cats and my immediate family.  Who knows, we may meet at some point in the distant future . . . . .

 

Kay

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Dear John:

 

I am sorry, John, but I do owe you an apology.  When I went back and re-read your post on anti-psychotic meds, I see that you did say "parents" when referring to bipolar kids.  I was thinking of your previous post in which you shared your blessings with us.  In that post, you specifically mentioned bipolar moms.  I am very sorry for this oversight.  I am glad to see that you are giving equal time to both bipolar moms AND dads.  It does appear that you are pretty comfortable with family members of people with bipolar.  I am sure that NAMI loves you dearly.

 

Again, my apologies for the oversight.  I will try to be more careful the next time I post my comments.

 

Kay

 

 

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John,

 

Thank you for your quick response.  I completely agree with you that the usage of anti-psychotics with kids is a very gray area.  You are absolutely correct when you say that they are dumb drugs.  I liked the way you put it in your post. 

 

Still, I do have grave concerns about the effects these kinds of drugs have on growing bodies and brains.  As you stated, the drugs are dumb and don't know which sites to go to.  This also could mean that they are going to sites they should not be going to and harming a child's brain.  I am not stating this based on scientific research.  My perspective is that of a lay person, who has had personal experience with these drugs, along with incidental and professional information I have picked up along the way. 

 

And just how smart do we have to be to make the dumb meds work well?  Can we ever truly be smart enough, when even doctors and scientists tell you they are not sure why the drugs seem to work.  They have come to some very compelling reasons for why they work but, ultimately, no one seems to know for sure.  That, to me, is the scary part.  The risk of not knowing whether or not these meds will have a serious, negative impact on my child, scares the dickens out of me.

 

Still, as with anything else in life, you have to weigh the positive against the negative. Are the positive effects of these medications worth the risk of the potential negative things?  I suppose that is a question every parent must pose, when faced with a decision to medicate or not, with a medication that we truly do not understand completely.

 

I certainly cannot speak for other parents out there who are put in the position of having to make these decisions.  I only know that, for me, when the doctor told me  and my mom that my child needed anti-depressant meds, I seriously questioned his diagnosis.  My mom and I decided not to medicate and, two years later, my son is doing very well in all aspects of his life.  Would it have been different if we had medicated him?  That is a question that we can only theorize about.

 

I am happy to hear that you take pleasure in the simpler things life has to offer.  You also value your many friendships and contacts that you have made, as a result of being a national speaker and writer.  As you said, most of your friends do not live close to you; they are friends you have made by being a national speaker and attending conferences, as well as writing your own newsletter.  This is all wonderful;  I, too, made many friends when I was speaking on a national level; of course, that was a long time ago, and most of my friends and I no longer have contact with each other.

 

Any opportunity a person has, to make and develop friendships is a wonderful blessing.  In my mind, I think about the many thousands (millions?) of people who would love to have the opportunity to make and meet friends the way you do.  The reality for most of them is that they will never have the opportunity to do this.  These are the people I think would truly benefit from conferences such as the ones you attend.  Apparently, they have not worked hard enough or tried hard enough to make it into the world of national conferences and speakers.  Oh, but for a taste of that life, would many a bipolar person cherish.  And why should they be denied because they have not earned the right to be there?  They earned that right by their experience with bipolar disorder.  As the Bible says, the path to heaven is not paved with good intentions or good works.  It is by faith that people shall come to inherit the kingdom.  I guess in the real world of national conferences and speakers, faith is not enough.  People have to prove themselves worthy.  I expect that gets very tiring after awhile.  They have already had to prove that they deserve the right to be treated fairly, with dignity and respect.  Why must life constantly be a battle of proving to everyone that we are worthy of what life has to offer?  What ever happened to just accepting people at face value and giving them the benefit of the doubt?

 

Time to go.  It has been a long, but very fulfilling week at work.  I have been able to help many customers with their service issues and I really like the feeling I get from assisting others.  When someone else expresses pleasure, it can be very contagious and spread like a wonderful bon fire.

 

Hoping that this post finds you well,

 

Kay

 

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The studies cited by the FDA in approving Risperdal for schizophrenia and bipolar disorder in children are discussed in this FDA report:

www.fda.gov/cder/foi/esum/2007/020272s046s047,020588s006s037,021444s020s021_risperidone_clinical_BPCA.pdf

The FDA tells us the safety for schizophrenia was based on 3 studies. One was placebo-controlled (6 weeks), one low-dose controlled (8 weeks), and one open-label (6 months).

The safety for bipolar disorder was also based on 3 studies.  One was placebo-controlled (3 weeks), one was the same "long-term" open-label study mentioned above (6 months), and one was a "pharmacokinetic" study (length of study not mentioned).


WHY DID THE FDA OMIT THE LENGTH OF THIS STUDY?  THE ANSWER CAN BE FOUND IN ANOTHER FDA DOCUMENT:

http://www.fda.gov/cder/foi/esum/2007/020272s046_risperidone_clinpharm_BPCA.pdf

"The population pharmacokinetic study was done in 472 children and adolescents patients, ages 6-18. Study durations were from 12-21 days."


THERE YOU HAVE IT:

AS LITTLE AS 12 DAYS!  3 WEEKS AT THE MOST!


This allows the FDA to declare with a straight face:

"There were no reports of tardive dyskinesia in the pediatric study populations."


If you want to see the real-world incidence of tardive dyskinesia caused by Risperal in children, you won't find it ANYWHERE on the FDA web site.  But you will find a glimpse here:

http://www.psychdrugdangers.com/risperdal.html


For a real-world look at Risperdal prescribing patterns in a state Medicaid program, go here:

http://www.psychdrugdangers.com/psychotropicages0-18.html

The above web page lists all 7,327 New Jersey Medicaid Risperdal prescriptions for children under age 18 written in 2006.  The Risperdal prescriptions are sorted by age and dosage.

Note the number of children on Risperdal rises steadily until ages 11 or 12, then the numbers begin to decline.  This is NOT because the number of children on antipsychotics begins to decline.  Risperdal is the GATEWAY antipsychotic, but after a year or two the kids are often switched to a different antipsychotic (usually Seroquel or Abilify first, then Zyprexa or Geodon, and/or back to Risperdal later).
Meanwhile all sorts of other psychiatric drugs are thrown into the mix, and before you know it these kids are REALLY sick... thanks to the wonders of modern medicine, and thanks to all the doctors who write all the prescriptions, and thanks to all the taxpayers who foot the bill.


In October 2006 the FDA approved Risperdal for autistic irritability in children, based on two 8-week trials of 76 kids on Risperdal and 80 kids on placebo, detailed here:

http://www.fda.gov/MedWatch/safety/2006/Oct_PIs/RisperdalTabs_PI.pdf


Adverse Reaction     Risperdal        Placebo
Tremor                       12%              1%
Dystonia                     12%              6%
Automatism (tics)         7%              1%
Dyskinesia                    7%              0%
Parkinsonism                8%              0%


Reviewing these trial results, I have a question:

How is it that 6% of the kids on placebo develop dystonia, while only 1% develop tremor?  Can anyone out there offer possible explanations???


One more thing:

The average dose in the Risperdal autism trials was under 2mg/day.  The FDA approved Risperdal for kids over age 5, 0.5 mg/day for 15-20 kg body weight, and 1mg/day for those over 20 kg.  Look again at the New Jersey Medicaid prescriptions for Risperdal, and count the number of 2mg, 3mg and 4mg scrips.  Not to mention all the kids under age 5 on doses ranging from 0.25mg to 3mg.

When the FDA approves a psychiatric drug at a certain dose for a certain age, history shows that doctors often ignore the FDA guidelines.

On the subject of Risperdal's pediatric dosage, the author of the FDA report had this to say:


"While I believe we should certainly label the drug with the information learned from the clinical trials, and even identify target doses of 3 mg/day for pediatric schizophrenia and 2.5 mg/day for pediatric bipolar I disorder, I think it would be too restrictive to the prescriber to limit the dose to a maximum when we know that doses up to 6 mg/day were also shown to be efficacious in the same studies that demonstrated efficacy for the lower dose ranges."


Yes that's what FDA Deputy Director, Dr. Mitchell V. Mathis really said.  You can read his full report here:
www.fda.gov/cder/foi/esum/2007/020272s046s047,020588s006s037,021444s020s021_risperidone_clinical_BPCA.pdf


Ben Hansen
Traverse City, Michigan

Institute for Nearly Genuine Research
www.bonkersinstitute.org

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