FDA considers approving antidepressants for children

April 30, 1997

INDIANAPOLIS (AP) Dr. Paul Riley has prescribed Prozac to
chronically depressed and obsessivecompulsive kids almost since it
appeared on the market in 1988.

After 35 years as a pediatrician and child psychiatrist, Riley says
he knows from experience that Prozac and drugs like it are safe and
effective.

"I lived in the old days when we didn't have antidepressants," said
Riley, now at St. Vincent Stress Centers in Indianapolis. "Fifty
percent of the people were dead" from suicide "within a year.
People don't remember that, but I do."

Now the Food and Drug Administration is considering formally
approving the use of Prozac in kids, a move that could help open a
huge market for Eli Lilly and Co., the Indianapolisbased maker of
the drug.

Some worry, though, that there haven't been enough studies of the
drug's effects on children.

And others are concerned that doctors will dispense Prozac for
typical adolescent moodiness, in the same way that the
hyperactivity drug Ritalin is said to be overprescribed to children
who are merely rambunctious or unmotivated.

"Once the drug is on the market, its use is totally up to
individual physicians, and hopefully it's based upon sound
scientific fact and not marketing," said Larry Sasich, a research
analyst for the consumer group Public Citizen.

Doctors can legally prescribe FDAapproved drugs for nonapproved
uses. But former FDA approval would allow allow manufacturers to
actually market the drugs for use in kids. That could bring around
many doctors and parents who might be wary of giving Prozac to a
youngster.

Young people could represent a huge new market at a time when drug
companies have seen sales of their bestselling antidepressants
begin to slow. Millions of children and adolescents are believed to
suffer from depression or obsessivecompulsive disorder, and
advocates say many go untreated.

Last year, U.S. physicians prescribed Prozac and competitors Paxil
and Zoloft to more than 580,000 children and adolescents, according
to the research firm IMS America Ltd.

About 28 million adult Americans in 1996 took the drugs, which are
known as serotonin reuptake inhibitors for their ability to boost
brain levels of the mood regulator serotonin.