Source:
http://www.webmd.com/content/article/128...RSS_PUBLIC
FDA OKs Drug for Autism Irritability
Risperdal Approved to Treat Irritability Related to Autism in Children By Jennifer Warner
WebMD Medical News Reviewed By Louise Chang, MD
on Tuesday, October 10, 2006
Oct. 10, 2006 -- The FDA has approved Risperdal to treat irritability in children and adolescents with autism.
It's the first approval of a drug for use in treating behavior-related problems associated with autism in children. Classified under the general heading of irritability, these behaviors include aggression, deliberate self-injury, and temper tantrums.
"This approval should benefit many autistic children as well as their parents and other care givers," says Steven Galson, MD, director of FDA's Center for Drug Evaluation and Research, in a news release.
Risperdal is an antipsychotic drug that has been approved for use in treating adults with schizophreniaschizophrenia since 1993; it has been approved since 2003 for the short-term treatment of adults with acute manic episodes or episodes with extreme mood swings.
The approval for treating children with autism was based on two eight-week clinical trials that evaluated the drug vs. placebo in 156 children 5 to 16 years old. The results showed that children on Risperdal significantly improved in measures of irritability associated with autism compared with children who received the placebo.
The most common side effects of Risperdal were drowsiness, constipationconstipation, fatiguefatigue, and weight gain.
Risperdal is manufactured by Janssen Pharmaceutica N.V. in Beerse, Belgium.
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SOURCE: News release, FDA.
Please have a look here:
http://www.apana.org.uk/risp.htm
edit:
Given how prone autistic people are to epilepsy, movement disorders, and catatonia, and given the fact that neuroleptics (including risperidone) can cause these things or make them worse (and are more likely to prove fatal when given to someone with catatonia), these claims are doubly unacceptable when it is known that they will lead to risperidone and similar drugs being given to unconsenting people. Additionally, the strategy of releasing drugs before long-term studies are done so as to avoid having to mention the long-term effects (as happened with risperidone and is happening every time a new atypical neuroleptic comes out) means that parents are giving their children drugs that have not been anywhere near adequately tested yet. The irresponsible promotion of risperidone as some kind of miracle drug for autistic people needs to stop, not just because of my personal experiences but because of the actual facts about the drug (as opposed to the hype). Too many people are being hurt, and, I fear, potentially killed.
(A.M. Baggs)
There are some important differences between the implications of prescribing for children or for adults. There are some important differences between prescribing to individuals on the autism spectrum or to other people who are not. These differences are mainly ethical and physical in their range. The most general ethical points are obvious and cluster around issues about consent and communication. The most general physical point re autism is that all drugs which affect dopamine should be used with great caution if at-all in people who may already have atypical dopamine regulation, which appears to be the case in many if not all people on the autism spectrum. The most general physical point re children is that since the drugs cannot be extensively tested in this population on a long-term basis and are known to disrupt or influence a very wide range of bodily functions, we do not know how physically harmful it may be to prescribe them to people who are still growing.
The research evidence which can be interpreted as supporting the idea that risperidone may be beneficial ‘for autism’ is often rather poor quality, for a variety of reasons. An important reason is that both positive and negative effects may take longer to emerge than the few weeks most trials last: somnolence and sedation tend to be interpreted as improved behaviour, fewer problems, even better sleep hygiene. Many adverse effects such as prolonged QT intervals, fatty liver, raised blood sugar and above all Tardive Dyskinesia may emerge as the cumulative total dose over time rises. All those effects are very serious, from being potentially fatal to causing lifelong disability. Another important reason why the research is of dubious relevance is that it is too easy to assume a lack of adverse effects in people who are unlikely to self-report. It is also too easy to assume that if some behaviour which we regard as a cause for concern is suppressed that that will be in the best interest of the individual, which is not necessarily the case.
Risperidone should never be prescribed at-all to growing children whether on the autism spectrum or not(...)
(Dinah KC Murray)
...
There are more contributions after (negative and positive).
Depression is the number one side effect of anti-psychotics and is quite common in autistics anyway. I would not want to see them prescribed simply for irritability.
And I would say much of the "irritability" is probably caused when too much pressure is placed upon these children to conform and they become overloaded.
And I would say much of the "irritability" is probably caused when too much pressure is placed upon these children to conform and they become overloaded.
That and "lack of communication" which can also be remediated; i am not sure but i think nearly all people can be taught to communicate in some way that works for them.
Noctivagus, I think he'd go well beyond being irritable - probably would be more like ropeable!
Sorry, I didn't mean to give you "dictionary wrist". Some other descriptives include "stroppy" and "berko". They could also be applied to somebody else we both know.
Dogface, sadly to say I think you are absolutely correct here. The Big Drug companies have a lot of clout in modern society. Even when a drug is found to have unacceptable side effects in say, the US, it is then shipped off to a developing country where people are considered more expendable.
Noctivagus, thanks. I can give you some more interesting words if you like eg. albescent, absquatulate, and carunculated.
In thje early days they wanted to give Amber risperdal and me and the pharmacist wife said, NO WAY!!!!!!
Giving anti-psychotics to a pre-pubescent child should be outlawed or punishable by a prison sentence.
BBBOOOOOOOOOOOOOGUUUUUUUUUUUUUUUSSSSSSSSSSS
<BOGUS>
I have a dear friend who was dosed up with valium during primary school and he doesn't even know why (he is not Aspie but has epilepsy). He used to have to have a sleep in the sick room for an hour or so during each school day.
Dosing kids with drugs should be seen as a last resort rather than a first option.
Dosing kids with drugs should be seen as a last resort rather than a first option.
bingo
Thanks Gareth. Also, I'm not sure if enough time has elapsed for all the long term effects of drugging kids with Ritalin and similar medications to show up.
I agree that drugs should be a last resort, and never forced on children. I think we'll soon see the long-term effects of Ritalin being prescribed too much for children with ADD. I'm about to get another psych evaluation for my SSI application process, and I'm going to remain adamant about not being put on any drug. I took an antidepressant for depression over 5 years ago, and it was very nasty.
Thank you for informing us about this, Mish.
This is really bad news, and sadly many children will suffer because of this. This news is proof that the authorities are listening to the loudest and strongest interest groups (NT parents and drug companies) to the exclusion of the more enlightened majority of the scientific community, who i think are starting to grasp the idea that autism/AS is a condition to be worked with, not against.
As a parent of kids who are certainly somewhere on the spectrum, and an aspie in an aspie family, I do understand that those on the spectrum can be a right royal pain in the backside to deal with at times, but drugging anyone just for being too much trouble and a painin the posterior is plainly unethical.
If I trotted along to my local GP and asked for an NT child of mine to be prescribed a drug to stop their temper tantrums, I'm absolutely sure the doctor would be horrified and deny my wish and would tell me to brush up my parenting skills instead. But If I asked a doctor to prescribe this sinister and powerful neurolepetic drug to banish the temper tantrums of an autistic youngster, apparently that's just fine. HOW IS THIS NOT DISCRIMINATION? :evil: