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ADELPHI, Md. — A Food and Drug Administration advisory committee will vote Wednesday on whether the makers of three blockbuster antipsychotic drugs — already widely prescribed "off-label" to children and teens — should be allowed to market them to treat schizophrenia and bipolar disorder in young people.
AstraZeneca's Seroquel, Pfizer's Geodon and Eli Lilly's Zyprexa are approved for schizophrenia and bipolar disorder in adults. Two other antipsychotic drugs, Risperdal and Abilify, already are approved for treating bipolar disease and schizophrenia in patients under 18.
"We generally are in agreement that the sponsors (the makers of Seroquel, Geodon and Zyprexa) have provided adequate support to suggest effectiveness" for treating those conditions in children and adults, said Thomas Laughren, director of the FDA's Division of Psychiatry Products, in a memo to committee members before the two-day meeting began here Tuesday.
In addition, Laughren said, the drugs' safety profiles appear to be "qualitatively similar to those observed with these drugs in adult patients." Adverse reactions that can occur with these "atypical" antipsychotics, he said, include sedation, weight gain, increases in blood fats and sugars and tardive dyskinesia, a condition characterized by involuntary repetitive movements.
Although the FDA isn't required to follow advisory committee recommendations, it usually does.
After listening to scientific presentations by FDA staffers and representativesfrom the three drug companies, panel members heard testimony from the public. No matter whether the speakers felt the companies should get the FDA's approval or not, virtually all agreed that more research is needed into the drugs' long-term safety and effectiveness in children and teens.
"Serious questions have not been answered," said Ronald Brown dean of the College of Health Professions at Temple University-Philadelphia. Three years ago, Brown chaired an American Psychology Association panel work group on psychiatric medications for children and adolescents.
Doctors prescribe the three antipsychotic drugs to about a million Americans ages 13 to 17 every year, says Diana Zuckerman, president of the National Research Center for Women & Families in Washington, D.C. "Unfortunately, the studies are inadequate," Zuckerman said. "They provide really no useful information about the long-term risks of tardive dyskinesia, sudden death or diabetes."
Christina Bagno of Brooklyn Heights, N.Y., says a combination of Seroquel and lithium have enabled her 7½ -year-old daughter, diagnosed with bipolar disorder, to live a normal childhood. "Antipsychotics saved my child," Bagno said.
But Liza Ortiz, of Austin, Texas, says Seroquel killed her 13-year-old son in January. He started hearing voices when he was 11 and was diagnosed with schizophrenia last year, Ortiz told the panel. Doctors prescribed a "cocktail" of antipsychotic drugs, she said, and he died four days after Seroquel was added to it.
David Fassler, a Burlington, Vt., psychiatrist who serves as secretary-treasurer of the American Psychiatric Association, says schizophrenia and bipolar disorder are "very real illnesses" in children and adolescents.
"In actual clinical practice, these medications are not used on a short-term basis," Fassler said of Seroquel, Geodon and Zyprexa. "We don't yet have sufficient data on longterm safety and efficacy in pediatric populations."
If the advisory committee recommends approving the three drugs for the treatment of children and teens, Fassler said, it should do so only for short-term or on-again, off-again use and only if manufacturers don't advertise their use in young people directly to consumers.
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