FDA Approves Another Antipsychotic for Children

Rob Wipond
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108

The US Food and Drug Administration has approved the atypical antipsychotic Saphris (asenapine) for use in “manic or mixed episodes associated with bipolar I disorder in pediatric patients” aged 10-17. The approval, according to Medscape, came as a result of positive results in only one clinical trial that lasted just three weeks.

“All three dose levels were associated with improvements in both mania and overall disease severity compared with placebo,” reported Psychiatric News. “Side effects included sleepiness, dizziness, strange taste sensations, numbness of the mouth, nausea, tiredness, increased appetite, and weight gain.”

FDA Approves Antipsychotic for Treatment of Pediatric Bipolar Disorder (Psychiatric News, March 13, 2015)

FDA Okays Saphris for Pediatric Bipolar Disorder (Medscape, March 13, 2015. Free registration.)

10 COMMENTS

  1. I’m still waiting for the reports showing the increased mortality rates of persons started on psychiatric drugs as children. There are several studies examining adults dying on-average 20-30 years earlier. What kind of future should a 10 year old expect when started on drugs like these? Will he/she even see their 30th birthday? I’m sure the FDA knows best.

    • I have worked with at-risk youth in one shape or form since 1998: alternative high school, Job Corps, and foster homes. If in deed psychiatric diagnoses are like any other medical diagnosis we wouldn’t be finding such a disproportionate rate of psychiatric drugging of at-risk children. Job Corps and Foster Youth are under a much higher rate of surveillance than other youth. Job Corps youth undergo an initial drug screen upon arrival at the center, and they have 30 days to get their THC levels down below an acceptable level, upon which they are retested. Also, upon the discretion of the drug counsel, they can be subject to random drug testing. Foster Youth are regularly tested and always so upon their return from a home visit.
      One of the more odious tasks that I was asked to perform at Job Corps was to write discipline referrals for kids sleeping in class. I butted up against management on this issue: In my experience, sporadic compliance with ADHD medication is one factor leading to sleepiness in class. Also given the high rate of usage of psychotropics in the US military, I deduced that similar usage was taking place with my students. Interestingly, neither my manager, the human resources director, nor my union rep could come up with a stated policy from the Department of Labor concerning the use of psychotropic drugs (Job Corps is run in partnership with the the Department of Labor and a private contractor-The prior contractor Management and Training Corporation is also in the business of running private prisons, including the one in Texas, where the most recent uprising occurred).
      The widespread drugging of these youth has occurred by the complicity of governmental authorities, which has allowed psychiatry to run unchecked. Piierre Bordieu (sic) the French sociologist posited that conservatives selectively rant against governmental social programs (the soft arm of the state) while valorizing the strong arm of the state (police and the military). Given the creeping mechanisms of control, including the clamor to drug test “welfare recipients’, the line between the two is becoming more blurred.

    • “Side effects included sleepiness, dizziness, strange taste sensations, numbness of the mouth, nausea, tiredness, increased appetite, and weight gain.”
      Weight gain after 3 weeks. That can’t end well. But we all know how this looks like, there’s enough data on these drugs from adults and other alike drugs (not that any of them is in any way better than the previous version – it’s all manipulated bs in order to extend patents) – it’s so outrageous I have no words to describe it and all that come close would probably be moderated.

  2. “The approval, according to Medscape, came as a result of positive results in only one clinical trial that lasted just three weeks.”

    Is it legal for the FDA to approve a drug based upon only one trial?

    “With regard to quantity, it has been FDA’s position that Congress generally intended to require at least two adequate and well-controlled studies, each convincing on its own, to establish effectiveness.”

    From: http://www.fda.gov/downloads/Drugs/…/Guidances/ucm078749.pdf

    And it strikes me that since the benefits have only been shown to exist within a three week trial, that should be the maximum length of time the drug is ever given to any child, since after that, who knows if there are any benefits at all. No one.

  3. “The approval, according to Medscape, came as a result of positive results in only one clinical trial that lasted just three weeks.”
    Wonderful. How diligent and thoughtful of the FDA to approve this drugs after such a comprehensive (and I’m sure not at all manipulated) study. There has to be a revolution.