FDA Approves Abilify Antipsychotic For Teens

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teens-and-pills.jpgThe Bristol-Myers med can now be used for kids between ages 13 and 17. This is the second schizophrenia med that the agency has endorsed for youngsters. Earlier this year, the FDA approved Johnson & Johnson’s Risperdal for kids in the same age group, as well as for treating bipolar disorder for children between ages 10 and 17.

The move comes after prolonged controversy over increased prescribing of antipsychotics for kids, despite a lack of FDA approval and studies indicating the meds are safe for youngsters. Bristol-Myers received the FDA nod based on results from a six-week, randomized, double-blind, placebo-controlled study that the drugmaker says demonstrated “significant improvement” compared to placebo on the primary efficacy endpoint, which measured symptoms. Side effects included extrapyramidal disorder, somnolence, tremor and weight gain. Here’s the press release.

Whether the FDA will make it three antipsychotics in a row remains to be seen. A three-member FDA team of medical reviewers initially urged rejecting Lilly’s Zyprexa for pediatric use because of inconsistent data from studies in US and Russian teens. But in an April 29 memo posted on the FDA’s Web site (look here), Thomas Laughren, head of the agency’s psychiatry division, wrote that the drug’s benefits in some studies outweighed the reviewers’ concerns.

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  1. In every deck of cards,there is a joker:…
    And Tom Laughren is the biggest “JOKER” at FDA..

    No one in their right mind would consider him to be a truthful human being….

    And Reality,
    If you would like to put your two cents in!!!…Im Ready.

  2. Congratulations Reality!!!!!

    You have replaced me, Atlex, and I am sure many others before us!!!!

    I have never in my life seen someone so intent on internet bickering. It reminds me of college football message boards.

    I wish I had more time, and by that I mean all day, to devote to picking internet fights, but darn it some of us are contributing to society! And by that I mean positively contributing.

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