It's rather sad that either it's ok or we have nothing better for austic kids that harm themselves or others than restraints, a chemical one in the case of abilify. It's horrible to imagine the choice a parent has to make when confronted with this choice.

We just have to do better.

When will the assault on children stop in the USA? when will the FDA become an agency that watches over the safety of children (and adults?)

As a parent of a 21 year old diagnosed with PDD/high functioning autism and as a teacher of children who do have very severe outbursts I can say that the children I teach and my daughter all became aggressive and agitated on Risperdal and Abilify.

I will leave it at that, this is a very sad day in news here, the FDA IS WORTHLESS!!!!!!!

This is absolutely astounding that in America we have a government regulatory body "FDA" that not only allows, but encourages the use of dangerous chemical behavioral controls/restraints on some of the most vulnerable segments of our population.

So this is what they meant by "change"; a brand new eugenics movement cleverly marketed and packaged as a "Treatment" pill.

As it's been said a thousand times before: "just follow the MONEY"

The saddest part about autistic kids is that many of them aren't verbal or are barely verbal and can't effectively tell anyone what these meds are really doing to them. It just makes me ill to think about it.

oh my gosh. how sad. =/

There are so many other choices - diet changes, supplements - that help. The parent just has to be smart enough to go that route, instead of the "easy choice" of drugging. The easy choice of drugging will turn out in the end to be the wrong choice, with all the side effects and long-term unknowns.

Oh, you can tell what it's doing to them. The student that I taught was totally non verbal and I knew something was wrong when he bit my hand and was agitated over the top when typically wasn't that agitated---so I asked and yes, in fact Risperdal has been prescribed, he also puffed up quite a bit with weight and he was only 10 years old and that was 4 years ago before the FDA approved the drug for use in kids at all.

No words are needed to describe drug-induced rages that last for hours at a time that's pretty easy to observe and connect the dots.

The FDA is a criminal entity, bought and paid for by pharma--hell those drug advisory FDA committee meeting panels are always loaded with conflicted "experts".

Remember the recent one where the psychiatrist had to be removed at the last minute? (for COI ie pharma money received) then they popped good old Barbara Geller in there as a sub? (CABF advisory panel)

It's a set up, these drugs (as I have whined about for years)will all be approved eventually for just about all reasons to take them, and no one truly has informed consent unless they research this stuff (the ghost writing, the non disclosed money received from companies, the skewed data in favor of study outcomes and the corrupt KOL's like Biederman and Nemeroff)then, with that information you stand back and wonder what the hell is going on here?

We've been targets, all of us, mothers, kids, adults...of a massive corporate industry that is out of control, making money hand over fist, at the expense of innocent lives.

Just like Zyprexa and Seroquel and Risperdal, next up in court for lawsuits via drug injury or internal company lies etc---will be Abilify and Geodon.

I hope the people who give these kids those drugs pay astute attention to the child's behavior after they take the drug, they will see, it's not always positive (I haven't seen one case yet, sorry but true if I do, I'll write about it).

Shame on the FDA.

These poor kids. I will be needing anger management is 3,2...

Just to play devil's advocate for a minute: the FDA is the FOOD and DRUG Administration, hence their purview is to make certain that consumable items like foodstuffs and medicines are safe and/or effective. And apparently Abilify is. Hats off to Bristol-Myers Squibb for recognizing this unmet need and capitalizing on the opportunity (pun partially intended).

The more important concern, in my mind at least, is one that the FDA cannot control, and that's our society's emphasis on the "quick fix" afforded by medications. Just as AnneS wrote, some parents and caregivers will reach directly for Abilify without asking what environmental triggers can be changed, or which coping strategies can be developed to help manage irritability. And in those cases, Abilify will probably work just fine.

I agree that people need to point out the long-term costs to society (and to patients) by focusing on the meds, but that's not the FDA's (and certainly not Bristol Myers') responsibility.

Abilify? Are they nucking futs? I was on Ability and it made me feel like my skin was turning inside out. And they're giving it to children? What's up with this system when major psychotropics are the answer for what's bothering our children?

This is appalling.
I thought that they had an agreement to leave children with autism alone.
No...
Who cares? They don't make money, only consume.
Let them be profitable by consuming Abilify.
Shame!

The FDA has a responsibility to make sure food and drugs are safe for all American consumers.

You would actually have to take a walk out on a very weak & shaky tree limb to believe atypical anti-psychotic "medicines are safe and/or effective" for use in treatment of irritability associated with autism in pediatric patients aged 6 to 17 years old."

It has become increasingly easy for many to blame parents; when it was the manufactures, FDA, and Doctors responcibility in the first place to make sure these dangerious and harmful drugs were never approved, and prescribed to these kids.

This old buck passing blame the patient/then the disease/and then the parent, arguments have gone on long enough; mumbled out by far to many MD's as an easy scape goat to shroud themselves in a false sense of innocence.

Doctors, please stop calling yourself medical professionals if you cannot act and treat responsibly. You took an oath "to do no harm" and not to "get rich, gain stature, and/or notoriety".

More good doctors need to take their ethical responsibility seriously, and begin to start holding their peers accountable for letting medicine go literally mad in greed, arrogance, and ignorance.

There are truly guilty parties in these drugging tragic scenarios:

1. Greedy pharmaceutical companies that are not in the business of Health Care or corporate ethics; They produce a product to make a hefty profit. Plane and simple truth in these modern times.

2. The FDA is guilty for ever approving drugs for children with such horrific side effect profiles. These drugs are no more effective than using an elephant tranquilizer gun to bring down a mouse.

3. Doctors that prescribe these drugs. There are no excuses any more; the information and results are in plan sight for everyone to see. PLEASE STOP looking in your wallet, and look into those kids eyes, while starting to develop a conscience.

Let us not ever forget these unsafe and "anything but easy fixes for the kids that take them" were created, and marketed by Pharma with one main goal "PROFITEERING".

Then they approved by the FDA with a little under the table wink and a smile from all those industry insiders working at a very shady and politicized FDA.

There are no long term studies about the devastating effects these drugs will have on children over the long hall. Without this vital information we are using Kids as virtual Ginny pigs and lab Rats today.

We do know that the short term negative effects far out weight any deemed benefits they may attach to these chemicals.

We also know the data/research is suspect at best with regards to the drug approval process.

Let us all consider the track record of these convicted criminals in pharma with a well established history of skewed data, misleading results, ghost written journal papers, funding of conflicted/tainted research (Yes, almost all the major pharmaceutical companies have admitted to felony fraud crimes, etc....... They are convicted criminals in America).

Is this who you trust mixing up your next batch of life saving medicine? Would you hire a convicted bank robber, as a teller at your bank?

Yet, in spite of all the information coming to light about the adverse effect of these drugs in children; it still took some doctor to recommend and write a script before any so called easy fix parent could use this so called treatment on their child.

It is about time the blame hammer lands squarely where it belongs, along with a giant helping of professional responsibility. Excuses will not save these kids lives from bad medicine or practice.

My personal opinion, you don't have to like it, or agree.

What if we imagined our autistic loved ones as highly, highly sensitive. Aware at deep levels of patterns of interaction that we are net yet able to comprehend. And at those deep levels, communication with others who are not so sensitively organized can be nearly impossible. Wouldn't we want to find better ways of listening and understanding? I highly recommend the book the 'Mind Tree.'

I blogged on a similar study, in April, and totally found a bogus, misleading analysis with another "atypical antipsychotic," seroqoul, for augmenting either lithium or valproic acid for bipolar.

I plan to dig up these Geodon studies to see if they used the same trick. Exposed in this post, half-way down:

http://www.medsvstherapy.com/2009/04/am-j-psychiatry-study-documents.html

Here is the trick: for most psych meds, you cannot get an easy blood measure of the drug level in body. But for lithiul and valproic acid, you can. So, you can get a study group to a level that is barely inside the "therapeutic window," barely inside the therapeutic range. This level will be effective for some but not most. [analogy: some but not most can have a headache clear up with a baby aspirin, so that 81 mg is the 'bottom' of the dose range to 'cure' a headache, while most of us need 200+mg]. THEN you "augment" the largely ineffective bipolar treatment with almost anything, and hope for at least a little placebo effect if nothing else, and have "proof" your augmentation works.

This method is all laid out in my blog post. I believe we will see many things approved as "augmentation" for bipolar on top of lithium or valprioc acid.