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FDA to Weigh Wisdom of Antidepressants for Kids

Widely used SSRIs and suicide connection discounted by most

MONDAY, Feb.2, 2004 (HealthDayNews) -- As the federal government focuses on the future of antidepressants for kids, health experts reiterate there is a real need for these medications.

But, they add, don't expect the government's public hearing, which begins Monday, to produce any clear resolution to the issue, save for a call for more research on the drugs, known as selective serotonin reuptake inhibitors (SSRIs).

"If there are some children who we're not allowed to treat with [SSRIs], it's going to be a real shame. That's why we're all waiting with bated breath for what's going to happen," says Dr. Jason Wuttke, a child and adolescent psychiatrist with the Ochsner Clinic Foundation in New Orleans. "My suspicion is that they're going to make a statement about cautions and about monitoring and about the need for research."

The panels in question, the Psychopharmacological Drugs Advisory Committee (PDAC) and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee (Peds AC) of the U.S. Food and Drug Administration, will be focusing mainly on whether the use of SSRIs for kids could raise the risk of suicide.

SSRIs, widely used antidepressants that include brand names such as Prozac, Zoloft and Effexor, have amassed quite a history. A decade ago, physicians and patients fretted over case reports indicating that some individuals, mostly adults, experienced a worsening of suicidal tendencies while taking the drugs.

Last year, the controversy flared again when British health officials advised doctors not to prescribe any SSRIs except for fluoxetine (the generic name for Prozac) for depressed youth under the age of 18 because the drugs might increase suicidal thinking and behavior.

Last fall, the FDA recommended that physicians not prescribe Paxil to children under 18.

Just last week, though, the American College of Neuropsychopharmacology (ACNP) concluded SSRIs are both safe and effective for children and teenagers.

The FDA groups will be focusing much of their attention on whether these drugs increase "suicidality," or thoughts of suicide.

Although there is a dearth of research on children and adolescents, experts in the field say they have not encountered this problem.

"There's an absence of a real link between suicidality and actual suicide," says Dr. Frederick Goodwin, a member of the ACNP panel and director of the Psychopharmacology Research Center at George Washington University Medical Center in Washington, D.C. "Studies in adults don't indicate a tight link at all between suicide ideation and actual suicide."

In fact, Goodwin adds, individuals (at least adults) who think about suicide are less likely to actually do it. And for those who do attempt suicide, their first attempt is likely to be their last, because they succeed, he says.

"The drugs have been used extensively in children -- and I mean extensively -- and they are not known for causing that type of problem," adds Dr. Jorge Armenteros, an associate professor of psychiatry at the University of Miami School of Medicine. "It's not as if you have situations where suicidality is occurring on a regular basis. In my experience, I have yet to see that."

Closely linked is the issue of bipolarity. Antidepressants given to a bipolar person without a mood stabilizer such as lithium can exacerbate the situation and put that person in a state associated with suicidal behavior, Goodwin explains. The problem is that it is notoriously difficult to recognize (and therefore monitor) this disorder in adolescents because they are often so moody to begin with, he adds.

All of these concerns ultimately lead back to the fact that there just have not been many studies done in children and adolescents. Clinicians mostly have to rely on data from adult studies and, as of now, the only SSRI actually approved for children and adolescents is Prozac.

"The efficacy problem is much more elusive in adolescents. There are no huge trials with hundreds and hundreds of patients," Goodwin says. "There are lots of smaller studies and a very strong consensus among child psychiatrists that these are important drugs to have in their armamentarium."

What is lacking in trial data may be at least partly compensated for by recent real-life data, which no doubt will be taken into account by the FDA experts. "In the very beginning, there was not that much in the way of experience using these drugs in children," Armenteros says. "This accumulates over time, and that's a difference between looking at the data now and looking at it five years ago."

Many people, however, are faulting the pharmaceutical industry for withholding information. A recent Washington Post article reported that manufacturers of SSRIs have refused to reveal the details of many clinical trials involving children and adolescents.

Again, experts hope the Monday meeting will lead to more access both for the public and for the academic community, says Dr. Harold Koplewicz, director of the New York University Child Study Center and author of More Than Moody: Recognizing and Treating Adolescent Depression.

The FDA's full analysis is not likely to be completed until this summer.

Meanwhile, experts are waiting, watching and hoping.

"We hopefully will be finding that the FDA will agree with the panel from the ACNP in remembering that, as of today, there has not been a single death due to SSRIs in children or adult," Koplewicz says.

More information

The American Academy of Child and Adolescent Psychiatry and the National Institute of Mental Health have information on depression in young people.

SOURCES: Frederick Goodwin, M.D., director, Psychopharmacology Research Center, George Washington University Medical Center, Washington, D.C.; Jorge Armenteros, M.D., associate professor, psychiatry, University of Miami School of Medicine; Harold Koplewicz, M.D., director, New York University Child Study Center, and author, More Than Moody: Recognizing and Treating Adolescent Depression; Jason Wuttke, M.D., child and adolescent psychiatrist, Ochsner Clinic Foundation, New Orleans; Jan. 29, 2004, Washington Post
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