FDA Debates Safety Of Antipsychotic Drugs In Kids

A panel of medical experts for the federal Food and Drug Administration is being asked to approve three powerful and expensive antipsychotic drugs for use in children. The FDA panel begins a two-day meeting outside Washington on Tuesday and is scheduled to vote Wednesday on whether to approve the drugs.

The hearing and the vote highlight growing use of these drugs by children, even as questions remain about their side effects.

The medications — Seroquel, Zyprexa and Geodon — are already approved for adults. Many doctors and parents say they can also be life-changing for children and adolescents with schizophrenia and bipolar disorder. Doctors already prescribe them to kids, even without FDA approval.

A Daughter's Milestone

Christina Bagno, of Brooklyn, N.Y., will testify about her 7-year-old daughter, who has been diagnosed with pediatric bipolar disorder.

"Back when she was 3 and before we tried medication, I wondered if she would be alive, frankly, you know, or at least living in our home," says Bagno, "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, and banging her head. And now she doesn't have the rages that she once had."

Until her daughter began those medications, she had hallucinations of explosions and dangerous things that kept her in a frequent state of anxiety and terror, Bagno says. Now she's able to settle down in school. She's learning to read and do basic math this year.

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

"It was tremendous, and she was just so happy," says Bagno, who belongs to a group called Families for Depression Awareness. "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."

Measuring Side Effects

Last week, FDA staff members released reports saying the three 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.

"If these children are starting these medications at very young ages, they're likely to be on them for many years," says Dr. William Cooper, a professor of pediatrics at Vanderbilt University School of Medicine. "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."

Cooper says bad outcomes may be worse in kids than they are in adults, and there needs to be more study of the side effects in children.

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

Over a similar period, another study found, the number of children diagnosed with bipolar disorder had increased 40 times. Still, Cooper says that doesn't explain all of the increase in the use of antipsychotics among children and adolescents.

Cooper says he was surprised that, in most cases in his survey, doctors weren't prescribing the drugs for serious mental illness. "Only one-third of the use was for bipolar or schizophrenia," says Cooper.

Instead, 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.

Mental Health Groups Urge Approval

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

On the eve of the hearing, a coalition of nine national mental health and suicide prevention organizations released a letter urging the FDA committee to keep the drugs available.

"Like cancer, aggressive treatment may be needed for some patients with bipolar disorder and schizophrenia, diseases with a higher risk of death than some forms of cancer," the groups said in the letter. They added that "no one treatment option works for all children," and that physicians and families need "a full range of medications and treatment options." The groups also called for more long-term research about the risks and benefits of these drugs to children.