FDA Approves Antipsychotic for Bipolar Kids: What Does It Mean?

John McManamy Health Guide
  • What is wrong with this sentence?


    "The powerful anti-psychotic drug Risperdal was approved by the US Food and Drug Administration on Wednesday for use in children and adolescents who have schizophrenia or bipolar disorder."


    This was the lead to a news report by HealthDay. Note the second word, "powerful." It is an emotionally-charged word. In certain contexts, such as "powerful CEO", the adjective is a compliment. But when describing a medication, there can be no interpretation but negative, especially when kids are thrown into the equation.


    Innocent fragile toddlers being force-fed powerful drugs. You get the picture.

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    Earlier this year, the New York Times reported:


    "When Anya Bailey developed an eating disorder after her 12th birthday, her mother took her to a psychiatrist at the University of Minnesota who prescribed a powerful antipsychotic drug called Risperdal."


    Ah, the P-word again. Think. If you are in a medical crisis, would you actually ask for a WEAK intervention?


    This week's news represents the first new generation antipsychotic approved by the FDA for use in kids for treating bipolar and schizophrenia (earlier, Risperdal picked up an autism indication). The indication comes in the context of an unprecedented round of bad press this year. It started in February with a report in the NY Times of the unfortunate death of Rebecca Riley, age 4, who had been prescribed extremely high doses of Depakote and Seroquel. The rest of the media picked up the story.


    More anti-drug, antipsychiatry stories followed, all of them based on a number of false assumptions, namely that: 1) Psychiatrists are "medicalizing" quite normal behavior in kids 2) Prescribing meds off-label (ie without FDA approval) is bad medical practice.


    Let's examine the first assumption. From the third edition of "The Bipolar Child" by Demitri and Janice Papolos:


    "One day, after [mother] Melissa refused to buy him candy, Eric [kindergarten age] ran out of the grocery store and attempted to run across the street. A few times he attacked her - hitting, kicking, and biting. Once, when sent to his room for a time-out, he opened the second-story window, knocked out the screen, and threatened to jump. Later he told his mother he thought he could fly."


    As Joseph Biederman MD of Harvard, who has pioneered the treatment of juvenile bipolar, explained to me, bipolar in kids is fairly easy to spot. We are talking about wild and frightening behavior, not something that can be mistaken for normal youthful rambunctiousness. In talking to dozens of bipolar parents, I keep hearing similar stories to the one related in "The Bipolar Child."


    These are kids who literally hold their families hostage, who act out in school, who are ostracized by kids their age, who can't sleep at night and can't wake up in the morning, who are in great pain and suffer mightily.


    Barbara Geller MD of Washington University (St Louis), who has tracked a cohort of kids over the years, once told a psychiatric conference that a manic kid is sicker than a manic adult.


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    As for the second assumption, at this year's American Psychiatric Association's annual meeting, one of the world's leading psychopharmacologists, Stephen Stahl MD PhD of UCSD, reminded his audience that the FDA regulates the sale of medicine, not the practice of medicine. The medical profession, he said, regulates the practice of medicine.


    Different psychiatric illnesses typically share some of the brain's biochemical pathways. For the medical part of treatment, it's all about matching the symptom to the compound. It's not about waiting for the DSM or the FDA to catch up to clinical reality.


    So is there any reason to be cynical over the FDA approving Risperdal in children? Yes. Risperdal went off-patent this year. Johnson & Johnson is now promoting "Son of Risperdal" marketed as Invega. The new indication breathes new life into the old drug.


    Further, the industry has been guilty of over-hyping new generation antipsychotics such as Risperdal as kinder and gentler and more effective versions of old meds such as Haldol. Psychiatrists and patient/family groups have bought into the hype, but are now reappraising their positions, especially with their significant side effects and metabolic risks. For many, antipsychotics are miracle meds, but for long term use it is wise to employ them advisedly


    Significantly, the FDA indication is for short-term use of the drug in children, not long-term.


    Any parent has the right to give their kid's psychiatrist the third degree when prescribing an antipsychotic, but in the final analysis, when your kid is in serious danger with a serious illness, do you act or do nothing?



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Published On: August 23, 2007