Antidepressant Use In Children Reviewed By FDA

Medications For Depression In Children Sometimes Needed, Physicians Report

< February 4, 2004 > -- 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 that the government's public hearing, currently underway, will unlikely produce any clear resolution to the issue any time soon, 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," says Dr. Jason Wuttke, a child and adolescent psychiatrist with the Ochsner Clinic Foundation in New Orleans. "That's why we're all waiting with bated breath for what's going to happen.

"My suspicion is that they're going to make a statement about cautions and about monitoring and about the need for research," Dr. Wuttke says.

In October 2003, the US Food and Drug Administration (FDA) issued a public advisory alert to physicians about reports of suicidal thinking and suicide attempts in clinical studies of various antidepressant medications in children with major depressive disorder.

Medications and Suicide Link Reviewed

Now, the Psychopharmacological Drugs Advisory Committee (PDAC) and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee (Peds AC) of the FDA will be focusing mainly on whether the use of SSRIs for children could raise the risk of suicide.

SSRIs, widely used antidepressants, include brand names such as Prozac^TM, Zoloft^TM, and Effexor^TM.

A decade ago, physicians and patients were concerned 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^TM) 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^TM to children under 18.

The FDA pointed out in its advisory that the medication labeling already states that suicide attempts are an inherent possibility in major depressive disorder. The FDA stated that high-risk patients should be closely supervised during initial drug therapy.

In addition, the FDA cautioned that a child should not discontinue using any of the prescribed medications without a parent first consulting the child's physician.

However, the American College of Neuropsychopharmacology (ACNP) panel that studied this issue recently concluded SSRIs are both safe and effective for children and teenagers.

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

Child Psychiatrists Defend Antidepressants

Although there is a dearth of research on this topic, many 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. "Studies in adults don't indicate a tight link at all between suicide ideation and actual suicide."

Dr. Jorge Armenteros, an associate professor of psychiatry at the University of Miami School of Medicine, says, "The drugs have been used extensively in children - and I mean extensively - and they are not known for causing that type of problem. 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."

Experts say too few studies have been conducted 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^TM.

"The efficacy (how well a medication works) problem is much more elusive in adolescents," Dr. Goodwin says. "There are no huge trials with hundreds and hundreds of patients. 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 clinical 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," Dr. Armenteros says. "This accumulates over time, and that's a difference between looking at the data now and looking at it five years ago."

Again, experts hope the committee meetings will lead to more access to information both for the public and for the academic community, says Dr. Harold Koplewicz, director of the New York University Child Study Center.

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 adults," Dr. Koplewicz says.

Always consult your physician for more information.

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Overview of Depression in Children

Depression is a mood disorder that involves a child's body, mood, and thoughts. It can affect and disrupt eating, sleeping, or thinking patterns, and is not the same as being unhappy or in a "blue" mood, nor is it a sign of personal weakness or a condition that can be willed or wished away.

Children with a depressive illness cannot merely "pull themselves together" and get better. Treatment is often necessary and many times crucial to recovery.

There are three primary types of depression, including:

• major depression (clinical depression)

• bipolar disorder (manic depression)

• dysthymic disorder (dysthymia)

Symptoms of Major Depression in Children

The following are the most common symptoms of major depression. However, each child may experience symptoms differently:

• persistent feelings of sadness

• feeling hopeless or helpless

• having low self-esteem

• feeling inadequate

• excessive guilt

• feelings of wanting to die

• loss of interest in usual activities or activities once enjoyed

• difficulty with relationships

• frequent physical complaints, such as headache

• sleep disturbances

• changes in appetite or weight

• decreased energy

• difficulty concentrating

• a decrease in the ability to make decisions

• suicidal thoughts or attempts

• running away or threats of running away from home

• hypersensitivity to failure or rejection

• irritability, hostility, or aggression

For a diagnosis of major depression to be made, a child often needs to exhibit a "cluster" (several) of the above symptoms during the same two-week period.

The symptoms of major depression may resemble other problems or psychiatric conditions.

Always consult your child's physician for a diagnosis.

Online Resources

(Our Organization is not responsible for the content of Internet sites.)

American Academy of Child & Adolescent Psychiatry

American College of Neuropsychopharmacology

Centers for Disease Control and Prevention (CDC)

HealthierUS.Gov

National Institute of Mental Health

National Institutes of Health (NIH)