FDA Approves Risperdal for the Treatment of Schizophrenia and Bipolar Disorder in Children
The approval by the FDA for the use of Risperdal in the treatment of schizophrenia and bipolar disorder in children is a momentous event. The decision was apparently made on the basis of a few very short term studies populated by a small number of subjects, a decision which is most uncharacteristic of the FDA. I have a number of acquaintances involved in drug development who have indicated to me that it is very difficult to find children available for any studies involving neuroleptics, let alone longer term studies. It is my opinion (and to a degree, my experience) that Risperdal and many other anti-psychotic medications have been prescribed off-label for children by psychiatrists for years because of the dearth of approved medications.
Risperdal is a powerful drug with both substantial benefits and significant side affects. Many fear that children may react differently than adults to such medications. In any event, because of this, and the short term nature and small populations of the studies done with children, the decision of the FDA is a courageous one. Because of this it is imperative that the consequences of the decision be closely monitored on a long term basis.
When I was diagnosed with schizophrenia at thirteen years of age over fifty years ago, I was immediately put on what at that time was the only neuroleptic available to anyone regardless of their age. It did not work well for me. My doctor and I then systematically tried every new medication that was introduced over the next ten years until we finally found a combination of drugs that returned me to full functionality. It is my firm belief that without the medications we tried over this 10 year period, I would almost certainly have experienced an increasing and irreversible loss of functional capacity over this ten year period and well beyond. In the end, after spending many years on the back ward of a state mental hospital, I would probably have long ago died on the streets. The trade-off in the use of these medications, at least for me, was enormous. The fact that my psychiatrist employed these medications profoundly changed my life for the better.
The many psychiatrists that have been prescribing neuroleptics off-label in an attempt to rescue the children in their care from the disastrous consequences of crippling and progressive brain diseases have done so at considerable personal and professional risk. Personally, I am pleased to see that the FDA has recognized the trade-off in the use of these medications in children and has now begun to share that risk by joining these psychiatrists in their compassionate struggle.
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