FDA Committee to Rule on Psych Meds for Youths

Youth Today
by John Kelly

The Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee will vote next week on whether to allow three psychotropic medications to be marketed as effective and acceptably safe for youths with certain conditions.

Doctors have been prescribing all three to children for years, and many of them are youths who are known to child welfare and juvenile justice systems. About 14 percent of youth in foster care are prescribed a psychotropic medication, according to a policy paper written in 2006 by the Institute for Juvenile Research at the University of Illinois at Chicago. And any committee vote of confidence is unlikely to curb what many believe to be an overreliance on psychotropics in dealing with troubled youths.

That a committee was asked to rule on the issue is itself a statement on the controversial nature of the issue. The FDA is not required to seek committee approval to accept a pharmaceutical company’s application.

“When an advisory committee is convened, it usually means the evidence is not so clear,” said David Cohen, a psychotherapist and professor at Florida International University. Committees are called in when “other issues need to be considered, or the consequences are so weighty.”

The three drugs up for discussion, their makers and their prescribed uses:

-Zyprexa, Eli Lilly: “for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the acute treatment of schizophrenia in adolescents.” Lilly agreed to pay the U.S. government $1.4 billion to settle criminal and civil cases regarding its promotion of Zyprexa for use with the elderly and children. The drug’s side effects include significant weigh gain and diabetes. Zyprexa is one of the three drugs that was prescribed to Gabriel Myers, the 7-year-old Florida foster child who is believed to have committed suicide. Myers’ death has prompted the Florida Department of Children and Families to examine the use of psychotropic medication by children in the agency’s care.

-Seroquel, AstroZeneca, “for the acute treatment of schizophrenia in adolescents from 13 to 17 years of age, and the acute treatment of bipolar mania in children from 10 to 12 years of age and adolescents from 13 to 17 years of age.”

-Geodon, Pfizer, “for the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features in children and adolescents ages from 10 to 17 years of age.”

In November 2008, the FDA’s pediatric advisory committee surprised the agency when it unanimously rejected a proposal that the FDA routinely monitor Zyprexa and another drug, Risperdal. The meeting was supposed to be a routine review of the pediatric safety of the drugs.

Cohen would like to see this committee act in a similar manner. Medicaid agencies are leery of the costs associated with the drugs, he said, and “This hearing is a desperate attempt to legitimize” the use of these drugs on children, Cohen said. A favorable ruling for the drugs’ manufacturers “would take lot of heat off” of them.

Notice of the meeting is available here http://edocket.access.gpo.gov/2009/E9-10451.htm on the Federal Register website.

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1 Comment

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One response to “FDA Committee to Rule on Psych Meds for Youths

  1. Katy Blake

    No. Keep the heat on the drug manufacturers and the drug pushers, psychiatrists and doctors who prescribe them. The use of psychotropic drugs (and many other drugs as well) has gone waaaay overboard, obviously by statistics and the deaths that have resulted. We need to go waaaay the opposite direction to really help ourselves and others. The use of psychotropic drugs should be tightly regulated, closely supervised, and their use reduced with the end goal of eliminating them. If the massive profits were taken away from the pharmaceutical industry and the psychiatrists, the manufacture and use of these drugs just might decline so that other real solutions would be more promoted and used instead of the drugs.

    What about the basics of correct nutrition, rest, exercise, and real communication/help in learning and teaching problem solving life skills for the life problems faced by both minors and adults? Life is full of problems for all of us, some more than others. Gabriel Myers life, according to the current information was very difficult. Getting true help in solving life’s problems gives us as individuals confidence, strength, and courage to persist and succeed in life. Drugs do not.

    Doctors and psychiatrists, by prescribing these drugs, encourage the masking of awareness, ability and responsibilty. HOW IS THIS HELP??? Aren’t they supposed to be really helping people??? However, they can be paid very handsomely for promoting drugs by the pharmaceutical industry.

    We need causative responsible, aware citizens at all ages who can solve their life problems, not drugged infants, minors, teens, adults and the elderly, as passive/suicidal sheep.

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