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FDA OKs Abilify for autism-linked irritability

November 20th, 2009

The Autism News | English

By Associated Press

The U.S. Food and Drug Administration has approved top-selling Abilify as a treatment for autism-related irritability in children from the ages of 6 to 17, drug maker Bristol-Myers Squibb Co. said Friday.

Bristol-Myers and Otsuka Pharmaceutical Co., based in Tokyo, are collaborators on the development and distribution of Abilify in the U.S. and Europe.

Abilify is Bristol-Myers’ second-biggest revenue generator, with $2.2 billion in 2008 sales.

The FDA’s latest approval allows the drug to be used to treat symptoms associated with autism such as aggression toward others, deliberate infliction of self-injury, tempter tantrums and moodiness.

The companies said in a statement that it was intended to be used as part of a more comprehensive treatment program that includes educational, psychological and social aspects.

Several other drug companies sell medications that compete with Abilify for customers. One is Schering-Plough Corp.’s Saphris, used to treat schizophrenia and bipolar disorder. Others include Pfizer Inc.’s Geodon, Johnson & Johnson’s Risperdal, AstraZeneca PLC’s Seroquel and Eli Lilly & Co.’s Zyprexa. The drugs have combined sales of well over $15 billion a year.

Bristol-Myers shares rose 4 cents to $24.50 in after-hours trading Friday after closing at $24.46, up 43 cents from a day earlier.

Source: http://www.forbes.com/feeds/ap/2009/11/20/business-health-care-us-abilify-fda_7147257.html

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  1. November 21st, 2009 at 09:51 | #1

    Amy Catron McCarty
    well finally!

    Cindy Killeen Waeltermann
    Abilify is an awful drug. It can result in tardive’s dyskenesia, excessive weight gain and has been linked to childhood diabetes and obesity.

    Jeanette Davids Guillory
    It works wonder for my son!

    Cindy Killeen Waeltermann
    Worked wonders for mine until it gave him PERMANENT tics.

    Gabriella True
    oh great, just what our kids need, more poison. Big pharm always wins out over real health

    Cindy Killeen Waeltermann
    Just throw drugs at them, they’ll be fine.

    Christina Nifong
    my son will never take drugs for his autism

    Cindy Killeen Waeltermann
    Let me reiterate — if it works for you, great. But abilify has been known to only be effective for a few months and then it has some nasty side effects. I don’t want to see anyone go through what we went through.

    Amy Catron McCarty
    Helped mine be able to actually BE in public and learn how to handle his behavior. I knew the risks, and he was on it for a year and we weaned him off. I saw great benefits. Yes there are risks…. and Cindy, while we all welcome your thoughts and opinions, you don’t need to be a jerk about it. We all do whats best in our own situations.

    Christina Nifong
    I think drugs should always be a last resort.

    Amy Catron McCarty
    We posted that at virtually the same time. Yes, with my son, he was on it for 4 months and off for 1 rotation. It helped us immensely – and was recommended with our DAN protocol. But, again, theres lots of knowledge to know before placing your kid on any medicine – and thats up to you to research before you decide. I’d never take just the word of any doc.

    Vicky Rojas
    I agree with Christina. And I appreciate the info Cindy! Thanks.

    Cindy Killeen Waeltermann
    Good that you took him off of it quickly. We had a hard time getting him back to baseline afterwards. Behaviors were awful. Most of the parents I talk to tell me that it only works short term.

    Amy Catron McCarty
    agreed there. I couldn’t figure out why it worked fantastic… then seemed to do nothing at all – pretty much overnight. No use keeping him on something I know wasn’t doing a darned thing! But he has been off of it for 7 months now – and completely med free. It just took a little more than a year for me to get control of him to get him to learn – and age a little…. before I could safely wean him, and know that he knew basic safety, and could focus and know rules.

    Jamie Wheeler
    Cindy- I didn’t think you sounded jerky, just honest. Sometimes it’s hard to hear that what’s working for you might not be the magic after all.

    Amy Catron McCarty
    “just throw drugs at em” is what I was referring to. Not productive.

    Jamie Wheeler
    I don’t think she meant you were at fault. Of course, we all want help/relief. But it is often the case that docs don’t want to listen to us when writing a scrip is so much easier. Ya know?

    Cindy Killeen Waeltermann
    It’s all good….. no fighting.

    Dala May Blethen
    Ugh I dont believe in medicating kids unless its absolutely necessary.

    Mandi Erickson Coats
    The decision is such an excrutiating one when it comes to “shall we medicate or not?” Clearly everbody is different. Some parents feel guilt and shame to share that their child is taking medication, but not all parents. I think when we make careless sarcastic statements such as “lets throw drugs at em” it can make parents feel even worse. Amy, sounds like it worked for you and for that I am happy! I understand it’s not the case in many of these situations.

    Jennifer Henry Radcliffe
    Necessary in our case, but we don’t use abilify. Our son wouldn’t walk into a room if there were other people in there! Made preK and family gatherings interesting, to say the least. We have him on low-dose prozac and the anxiety has been drastically reduced. But, it really was a last resort, we tried everything else we could. He responds very well to the prozac with no side effects and has been on it for about 2 1/2 years (he’s now in 2nd grade and thriving!). Our doctor mentioned adding abilify when our son was briefly regressing, but I didn’t like what I’d heard about it so I declined. We slightly raised the dose of the prozac and saw results within 2 weeks.

    Carole Rutherford
    I know families here in the UK whose adult kids are now locked up because of the medication they were prescribed as kids. It’s not always an immediate fall out. It’s not for us.

    Maria Mills Greenfield
    When I decided we had to medicate, my son was 17. I asked my dr for prozac, he said “I’ll put him on it, but it won’t help”…. 3 DAYS later I stopped by his office to re-introduce him to his “new” patient. Prozac helped tremendously, but now, several years later, we are struggling again. He recently put him on respirdone, with benztropine to counteract the bad side-effects of the respirdone…now he’s having all sorts of problems…can’t see, lethargic…on the lowest dose… so maybe I’ll ask the Dr. to try the abilify! This is great news for us!

    Amy Gould Caraballo
    Abilify works no better than Risperdal and in fact, caused more anxiety in our kiddo. In the end, finding out what the irritability was about (in our case, PTSD), was key in curbing it!

    Rachel Ezekiel-Fishbein
    My son has Tourette and ADHD and when we finally learned why he was different, he would have done anything to be able to control his behaviors (I know, because he told us he wished he knew why he couldn’t and wanted to know how we cold help him). Abilify has been a God send for him and us. I disagree that drugs are a last resort. I would give my child medication for diabetes or epilepsy. Why would I withhold meds for a neurological difference, when using them might let more of him out, rather than make him be controlled by his disability.

    Jennifer Henry Radcliffe
    Rachel, because some neurological disorders can be improved with behavioral/speech/occupational therapies, and side effects for drugs can be dangerous. But- each person is different, and what works for one may not work for another. My son’s anxiety did not improve despite all his therapies and behavioral interventions, so we tried meds. Thankfully it works well with no noticeable side effects.

    Jennifer Henry Radcliffe
    Maria, you may want to try the prozac again in the future. It could be that your son’s body needed a break from it, and it might work again. It’s very difficult to get the right dose, especially because kids and teens grow so fast. And boys can keep growing till they’re 22!

    VoicingAutism Esther Irizarry
    My 7 yr old son has been on abilify for about 2 yrs now. It worked like a miracle, the first 10 days, then tapered off a bit. We did stop it for a short period as we thought it wasn’t helping as much as we’d hoped, he’s chronically hyper/adhd as well as autistic, but when he was off of it he awoke from sleeping in an absolute rage, very destructive. So he’s been back on it ever since.

    Matt Musikar
    As stated in the previous posts . The right dosage is key. You know your child best. My son has been on abilify since April. It does have its pros and cons but does enable my 5 year old to somewhat focus in a CABAS/Greer school. Learning and understanding is key.

    Donna Williams
    could be an idea to look at salicylate intolerance… which effects salicylate intolerant people like cocaine… and look at 1000mg omega 3s as a natural mood leveller… worth a thought.

    Donna Williams
    low salicylate diet and omegas is used in both the ADHD and bipolar communities

    Gabrielle Hogg
    i don’t like this, no body knows the long term effects on any medications!

    Alyson Bradley AsPlanet
    Having aspergers, bipolar and adhd I have never used any medication and only advice ever been given is to take… I grew up watching my mother on one medication after the next, up the dose, down the dose, that was her life and she never found sefl or was happy when alive…

    I accept who I am and work with my moods, imy differences as apart of who I am as an individuals, it does mean living a healthy balanced life, but to me no choice never want to take serious medication have taken omega 3 etc… personally I feel only a very few children should be on medication, those in real need, because if medicated to simply control behaviour they may not have a choice when older, in away I am glad no one notice me in that respect because I would of been put on medication if born now….

    Cindy Killeen Waeltermann
    @Gabrielle — I agree. I read “this is great news for our kids” and cringed. I’m not against ALL meds — Temple Grandin gets relief from antidepressants, but ABILIFY IS A DANGEROUS DRUG. DO YOUR RESEARCH PEOPLE.

    Rachel Ezekiel-Fishbein
    Jennifer, completely agree with you. I say throw everything you’ve got at the problem and learn what works for your individual kid. The thing is that most of us don’t know what it feels like to be inside our kid’s body or brain, and it is our job to try to make life as livable and happy for them, and to give them all of the tools they need to thrive.

  2. November 24th, 2009 at 10:18 | #2

    Amy Catron McCarty
    Abilify is just as dangerous as most of the others. Im just glad its now approved for children instead of reading all over the place that its not, yet my kid was still taking it. That was the point, I believe of this post. Not for one to say “do your research”. Most of us research every day. Its a part of our lives to do whats best suited for our children. I knew the risks, but the benefits we saw outweighed the risks at the time. My son made awesome progress while using it.

    Kristy Casey Deal
    Omega 3 has helped in our household – also a balanced multi-vitamin meeting his vitamin b needs as well as others – I have never medicated my kids for their autism – there is not enough known about the repercussions down the line. I hope that you will all try nutritional therapy – it has done wonders for my boys! Check out some great diet info on the Autism & Nutrition group, too! The gut has a lot to do with what our kids go through too! We just got our Probiotic Plus to try to day and I am so excited! I will try natural sources all day , but as for me ans my house we try to stay drug free! And this is not meant to offend anyone who uses them! Grin

    Amy Catron McCarty
    We have done both, and I dont think anyone will be offended by your ideas. Thats what we are all here for. Omegas made my son crazy though. Again, its all a trial and error with each individual kid. Its just a wild roller coaster ride Wink

    Matt Musikar
    well said Amy. Anyone know of about Nemenda and uses for Autism?

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