FDA Approves anti-psychotic drug for Children with Depression

Deborah Gray Health Guide
  • When I first read the headline that the FDA had approved the first anti-psychotic for use in children, I was, shall we say, apprehensive. When I read further into the story, I didn't feel any better.


    I am not anti-medication when it comes to psychiatric ills, even in children. But neither am I a huge fan of the FDA. Their approval of a drug makes it seem completely safe in the eyes of most consumers. Over the past few years, however, we've found that that sense of security that consumers have in the FDA's approval of a drug may be misplaced (Vioxx, anyone?).


    My main thought as I read the story was, "What the hell are they basing this approval on?". I was pretty sure that there hadn't been any large-scale testing done on children with Risperdal. Sure enough, the reports said that the FDA had relied on two short-term trials (three weeks!). You have got to be kidding me.

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    The FDA, post-approval, is asking the drug's maker to begin a study looking into the potentially negative impact on adolescent growth and development. Do you know how much incentive a drug maker has to do a study after a drug is approved? Zippo.


    I realize that this Risperdal approval is potentially a boon for children who have been dealing with schizophrenia and bipolar disorder and their parents. In some severe cases, using a largely untested drug is worth the risk. My concern is for the other 90% or so of parents who are operating under the assumption that anything the FDA approves is completely safe and thoroughly tested, and therefore allow their children to be put on a powerful anti-psychotic when there are other options.


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Published On: August 24, 2007