WASHINGTON -- The Food and Drug Administration yesterday approved the antipsychotic drug Risperdal to treat children with schizophrenia and bipolar disorder.
The FDA allowed Risperdal as a treatment for adults with schizophrenia in 1993, but until now psychiatrists did not have an approved drug to treat schizophrenia in youths.
More than 2 million Americans have schizophrenia, a condition characterized by the inability to differentiate between real and unreal experiences, to think logically, or to behave normally in social situations. One in 100 Americans will be diagnosed with the disease, but the bulk of diagnoses occur between ages 15 and 25, said Jeffrey Lieberman, chairman of psychiatry at Columbia University.
Once the FDA approves a drug for adults, manufacturers seldom retest it in children. Physicians, however, frequently treat children with drugs approved for adults -- a practice called off-label prescribing -- without knowing the proper dosing or whether the therapies even work in children. Drug industry critics say companies should conduct more pediatric trials, a push reflected in legislation pending before Congress.
The FDA asked Risperdal's maker, Janssen LP, to study it in children. The Titusville, N.J., manufacturer complied within five years, a relatively speedy turnaround. Janssen, a subsidiary of Johnson & Johnson, conducted clinical trials involving nearly 600 children. Based on those results, the FDA approved the drug for use in children ages 13 to 17 with schizophrenia and agreed to its short-term use to treat manic or mixed episodes of bipolar I disorder in children ages 10 to 17.
Because newer antipsychotic drugs, such as Risperdal, carry serious -- and sometimes fatal -- side effects, the FDA considers the pediatric studies on its use significant, as does the American Psychiatric Association, whose 38,000 members diagnose, treat, and conduct research into mental disorders.
Because Risperdal is also in a class of drugs associated with weight gain that can lead to diabetes, Janssen, at the FDA's request, is conducting a longer-term trial to look at weight gain and any impact that earlier use of the drug may have on children's growth and development.
Still, the FDA's move, which was made without first airing scientific data publicly through an advisory committee hearing, is certain to stoke an already fierce debate about how frequently such drugs should be prescribed.
Antipsychotics, among the nation's top-selling pharmaceuticals last year, already generate $16 billion annually for drug makers. Last year, Risperdal was the second best-selling antipsychotic in the United States, with $2.6 billion in sales, according to
Some argue that adults have been overprescribed such drugs, driven, in part, by aggressive advertising campaigns. They should not be prescribed to growing children, said Vera Hassner Sharav, founder of the Alliance for Human Research Protection, pointing to the drugs' link to such side effects as uncontrolled growth of breast tissue in boys that must be corrected by surgery.
FDA approval "helps to provide doctors cover," Sharav said. "These are dangerous, toxic drugs. Every piece of evidence points in that direction."
But Dr. Carolyn Robinowitz, president of the American Psychiatric Association, said medications are "an important part of a comprehensive treatment program."
Columbia's Lieberman agreed, with caveats. A study that he led, funded by the National Institutes of Health, found that older, cheaper drugs worked as well in treating adults with chronic schizophrenia as newer, second-generation drugs like Risperdal. The older therapies also cost one-10th the price.
FDA approval of Risperdal use among children is "great to know," Lieberman said. "Now, we can use it with a higher degree of confidence. The question is, with the cost of the newer medicines, do we think the older medicines would do as well? Are the newer medications, indeed, better?"
A second, NIH-funded trial that aims to answer that question is complete, but its results have not yet been published, he said.
Diedtra Henderson can be reached at firstname.lastname@example.org.