FDA Docs: Antipsychotic Drugs for Kids Have Risks, Benefits

Glory download Last week we wrote that a U.S. Food and Drug Administration (FDA) advisory panel vote was scheduled regarding three psychotropic medications and their safety and efficacy for children with specific conditions. Now, the Wall Street Journal reports that the agency has said that the medications—AstraZeneca PLC’s Seroquel, Eli Lilly and Company’s Zyprexa, and Pfizer Inc.’s Geodon—effectively treat some psychiatric disorders in pediatric patients, but come with serious risks, including sedation and weight gain.

The FDA is looking at the possibility of taking applications for <"http://www.yourlawyer.com/topics/overview/Seroquel-And-Cardiac-Death">Seroquel

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and <"http://www.yourlawyer.com/topics/overview/zyprexa">Zyprexa for bipolar disorder and schizophrenia in children and adolescents, and <"http://www.yourlawyer.com/topics/overview/geodon">Geodon

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for bipolar disorder in children 10 to 17, said the Journal. The FDA

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panel of external medical experts is meeting later this week to vote on the drugs’ safety and efficacy in pediatric patients, said the Journal.

The risks, said the FDA’s psychiatric product division director, Thomas Laughren, “are of particular concern in pediatric patients because of the life-long nature of these disorders,” quoted the Journal, which added that the issue with weight gain as a result of many antipsychotic medications is that extra weight can lead to diabetes and cardiovascular disease.

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Although not FDA approved for the pediatric treatment of bipolar disorder and schizophrenia, Seroquel, Zyprexa, and Geodon have long been prescribed off-label to this demographic for these diseases. 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 last week. 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.

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.

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.

The FDA asked the drug makers to look into the side effects more prevalent in children versus adults reviewed in clinical trials, reported the Journal. Lilly said Zyprexa showed increased weight gain and blood lipid changes in children over adults. AstraZeneca said Seroquel side effects seen more in children over adults included increases in blood pressure and appetite as well as some movement side effects, including tremors. Pfizer’s Geodon in children was linked to increased sleepiness or sedation.

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