FDA Debates Safety Of Antipsychotic Drugs In Kids More and more children are getting prescriptions for three powerful antipsychotic medications that have been approved for use by adults. Many doctors and parents say the drugs help children, but questions remain about their side effects. The FDA is scheduled to vote Wednesday on whether to approve the drugs for children.
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FDA Debates Safety Of Antipsychotic Drugs In Kids

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FDA Debates Safety Of Antipsychotic Drugs In Kids

FDA Debates Safety Of Antipsychotic Drugs In Kids

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Let's turn now to an ongoing issue involving children and drugs. More and more are getting prescriptions for antipsychotic medications. Those drugs have been tested and approved, mostly for adults. Now the Food and Drug Administration is hearing from parents and outside experts about whether three of these drugs should or should not be prescribed to kids. NPR's Joseph Shapiro reports.

JOSEPH SHAPIRO: Christina Bagno will testify before the FDA Advisory Panel today. She's got a seven-year-old daughter who's been diagnosed with pediatric bipolar disorder.

Ms. CHRISTINA BAGNO: Back when she was three, and before we tried medication, I wondered if she would be alive, frankly, or at least living in our home, because her own rages were so very scary and destructive. She would bite herself — to the point of bite marks up and down her arm, banging her head. And now she doesn't have the rages that she once had.

SHAPIRO: Bagno will tell the FDA Panel that until those medications, her daughter had hallucinations of explosions and dangerous things that kept her in a frequent state of anxiety and terror. Now she's able to settle down in school. She's learning to read and do basic math this year.

And this past weekend, there was another milestone: her first sleepover with a friend.

Ms. BAGNO: It was tremendous, and she was just so happy. It was a joy to watch — just to see her have a friend like that and have her be able to sit and watch a movie with a friend and have a pillow fight and just do all these things that kids do is just, really, a blessing.

SHAPIRO: Drug companies are asking the FDA to approve three drugs for use in children. The medications — Seroquel, Zyprexa and Geodon — are already approved for adults. And doctors already prescribe them to Christina Bagno's daughter and at least two million other children, even without approval from the FDA.

Last week, FDA staff members released reports saying the drugs do help kids, but that there are serious side effects. They can cause sedation, heavy weight gain and other problems that can lead to heart disease and diabetes.

Dr. William Cooper is a professor of pediatrics at Vanderbilt University. He says the side effects may be more serious for kids than what's been seen in adults.

Dr. WILLIAM COOPER (Professor of Pediatrics, Vanderbilt University School of Medicine): If these children are starting these medications at very young ages, they're likely to be on them for many years. So the adverse effects, such as weight gain, increased lipids, increased blood sugar are likely to have potentially long-term and important side effects for these children.

SHAPIRO: Cooper started seeing a lot of kids coming to his clinic who had been prescribed these expensive and heavily marketed medications designed for adults, so he did a national survey and found that the number of prescriptions to kids had increased five times over a recent seven-year period.

Cooper was surprised that in most cases, doctors weren't prescribing them for serious mental illness.

Dr. COOPER: Only one-third of the use was for bipolar or schizophrenia.

SHAPIRO: Nearly 30 percent were prescribed to kids diagnosed with attention deficit hyperactivity disorder; nearly 15 percent went to children and adolescents with no psychiatric diagnosis at all.

Still, Cooper thinks these medications are important tools to help kids with bipolar disorder and schizophrenia. Most pediatricians and child psychiatrists agree. The FDA has already approved two similar antipsychotic drugs for kids.

The FDA experts will hear two days of testimony, then tomorrow afternoon, they're scheduled to vote whether three more of the drugs are effective and safe for use by children 10 to 17 years old.

Joseph Shapiro, NPR News.

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