FDA Panel to Vote on Seroquel, Zyprexa and Geodon for Kids

A vote is scheduled for next week regarding three psychotropic medications and their safety and efficacy for children with specific conditions. Youth Today reports that although the U.S. Food and Drug Administration (FDA) does not need committee approval for pharmaceutical company applications, the agency’s Psychopharmacologic Drugs Advisory Committee will be voting on <"http://www.yourlawyer.com/topics/overview/zyprexa">Zyprexa, <"http://www.yourlawyer.com/topics/overview/Seroquel-And-Cardiac-Death">Seroquel

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, and <"http://www.yourlawyer.com/topics/overview/geodon">Geodon.

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While it is widely known that physicians have been prescribing Zyprexa, Seroquel, and Geodon to pediatric patients for some time, what might not be known is that many of those younger patients have connections to child welfare and juvenile justice systems, said Youth Today. For example, approximately 14 percent of children in foster care are prescribed some psychotropic medication, reported Youth Today citing a 2006 policy paper written by the Institute for Juvenile Research at the University of Illinois at Chicago.

The issue is rife with controversy because not only is the FDA not required to obtain approvals of this sort, many critics feel that there are too many so-called “troubled” children prescribed psychotropic medications, pointed out Youth Today.

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According to David Cohen, a psychotherapist and professor at Florida International University, “When an advisory committee is convened, it usually means the evidence is not so clear,” quoted Youth Today, which added that these types of committee rulings are sought in cases when “other issues need to be considered, or the consequences are so weighty,” said Cohen.

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For instance, in the case of Eli Lilly’s Zyprexa, prescribed “for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the acute treatment of schizophrenia in adolescents,” quoted Youth Today, there have been huge financial settlements linked to illegal marketing as well as significant adverse effects. Lilly agreed to pay the government $1.4 billion to settle criminal and civil cases, noted Youth Today. Zyprexa is known to cause significant weigh gain; diabetes, hyperglycemia, and other blood sugar disorders; lowering of good, or HDL, cholesterol levels; and cardiac issues.

AstroZeneca’s Seroquel is, quoted Youth Today, prescribed “for the acute treatment of schizophrenia in adolescents from 13 to 17 years of age, and the acute treatment of bipolar mania in children from 10 to 12 years of age and adolescents from 13 to 17 years of age.” This January, a study published in The New England Journal of Medicine found that patients taking Seroquel and other atypical antipsychotics were more likely to suffer sudden cardiac death than patients taking older antipsychotic drugs. This April, an FDA advisory panel cited the risk of Seroquel sudden cardiac death when it recommended the drug not be approved as a first line treatment for depression. AstraZeneca faces over 9,000 Seroquel lawsuits filed by people who claim the company withheld information about the antipsychotic drug’s diabetes risk.

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Pfizer’s Geodon is prescribed “for the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features in children and adolescents ages from 10 to 17 years of age.” In addition to blood sugar risks, there are concerns Geodon might increase the possibility of a specific, potentially fatal heart-rhythm irregularity. Additional side effects include: Feeling unusually tired; nausea; constipation; dizziness; restlessness; diarrhea; rash; cough; runny nose; and abnormal muscle movements, including tremor, shuffling, and uncontrollable movements.

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