FDA GOV DOC: DRUGS ADVISORY COMMITTEE
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http://blogs.wsj.com/health/2009/06/05/fda-sees-benefits-risks-in-antipsychotics-for-children/
June 5, 2009, 3:17 PM ET
FDA Sees Benefits, Risks in Antipsychotics for Children
By Shirley S. Wang
Powerful antipsychotics currently used to treat adults for schizophrenia and bipolar disorder appear to be effective in treating children and teens as well, though there are serious risks associated with the medicines, according to documents put out by the FDA staff today.
AstraZenecas Seroquel, Eli Lillys Zyprexa and Pfizers Geodon are all being considered by the FDA for use in children. A panel of outside experts will meet next week to discuss the risks and benefits of these medicines for use in children and make a recommendation to the FDA.
Though they work at combating serious symptoms such as delusions and hallucinations in schizophrenia, or severe mood swings associated with bipolar disorder, the drugs also appear to induce weight gain and sleepiness, according to Dow Jones.
These risks are of particular concern in pediatric patients because of the life-long nature of these disorders, wrote Thomas Laughren, director of the FDAs psychiatric product division, in a memo.
Recent studies of effectiveness have shown that the antipsychotics arent as good as previously believed. They reduce some symptoms for some people but they help too few people recover, Thomas Insel, director of the National Institute of Mental Health, wrote in an email to the Health Blog. We really need a new generation of compounds that will target the full range of problems in serious mental illness.
Insel said using antipsychotics in children is a tough balance between the risk vs. the benefits of the medicines. With current antipsychotics you risk either metabolic side effects or neurological side effects, he wrote. Sometimes these potentially serious risks are worth the benefit, but in children the balance needs to favor minimizing risks.
Currently only two antipsychotics, J&Js Risperdal and Bristol-Myerss Abilify, are approved for use in children."
