FDA Questions Use of Antipsychotics in Children

Antipsychotic medications can carry serious risks, especially for children, warn experts.

Drug regulators need to do more to warn physicians and patients about the serious risks of antipsychotic medications, especially for children, a panel of FDA experts said on November 18.

Panel members were concerned with the use of Risperdal, as well as others in its class, such as Zyprexa, Seroquel, Abilify, and Geodon. More than 389,000 children and teenagers were treated last year with Risperdal, 240,000 of whom were 12 or younger. In many cases, the drug was prescribed to treat attention deficit disorder (ADD ADHD).

The risks include substantial weight gain, metabolic disorders, muscular tics that can be permanent, and in rare cases, fatal strokes. Because the drug has not been approved for attention deficit disorder (it is currently prescribed off-label), panel members felt the risks were too great to justify its use in treating ADHD.

In the past year, Risperdal prescriptions to patients 17 and younger increased 10 percent, partly due to the increase in the diagnosis of pediatric bipolar disorder.

As of now, no studies have been done to test the drugs’ long-term safety.

Read more about the warning.