Student Well-Being

FDA Cautions Doctors That Antidepressants May Pose Youth Risks

By Darcia Harris Bowman — November 05, 2003 3 min read
  • Save to favorites
  • Print

Concerned that antidepressant use may lead to suicidal behavior in children and adolescents, the U.S. Food and Drug Administration is urging doctors to proceed with caution when prescribing the medications to youngsters.

In a health advisory issued Oct. 27, the FDA cited as the source of its concern “an excess” of reports of suicidal thinking and suicide attempts in clinical studies of pediatric patients taking such drugs to treat severe depression.

Richard Lieberman, the coordinator of the suicide-prevention program for the 740,000- student Los Angeles school district, applauded the federal warning.

“I think it’s prudent—we need to back the truck up,” the school psychologist said. “I don’t know that there’s been enough study on the use of these drugs on children.”

In 20 placebo-controlled trials overseen by the FDA for eight antidepressant drugs, involving more than 4,100 pediatric patients, there were no reports of completed suicides. The data did, however, suggest more suicidal behavior and thinking among patients who were assigned to several of the antidepressants, compared with those who were given placebos, according to the FDA advisory.

Though the evidence is far from conclusive, the agency warned that “it is not possible at this point to rule out an increased risk of these adverse events for any of these drugs” when children with severe depression take them.

The drugs studied in the trials were: citalopram, fluoxetine, mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine. Fluvoxamine was also included, though it is not approved for use as an antidepressant in this country.

Of the eight medications, Prozac, the brand name for fluoxetine, is the only one the FDA has approved for use by children and adolescents with depression.

‘Difficult Task Ahead’

The advisory last week is not the FDA’s first on pediatric use of antidepressants. Last summer, the agency warned against prescribing Paxil, the brand name for the drug paroxetine, for children and adolescents because three controlled studies of pediatric patients using the drug showed “possible increased risk of suicidal thinking and suicide attempts.”

Clinical studies had failed to show that Paxil was even effective in treating children who suffered severe depression, the agency noted in a June 19 warning. The FDA never approved Paxil for use on pediatric patients.

School health experts said last week they hoped the federal advisory would prompt greater communication between the doctors who prescribe antidepressants to children and school health officials. And some said they hoped parents would be more assertive about asking prescribing physicians whether a drug is even approved for use on younger patients.

“The decision of whether to put a student on an antidepressant is best made by a team that includes the parents, the school-health personnel, and the prescribing physician,” said Scott Poland, the director of psychological services for the 75,000-student Cypress-Fairbanks school district in Houston.

Several mental- health experts said it was important to note the cautious tone of the FDA advisory.

The agency “is not saying they have proof that antidepressants cause children to commit suicide,” said Stephen E. Brock, an assistant professor of psychology at the California State University-Sacramento. “What we should all do is continue to be vigilant in watching for suicidal behavior and ideation in individuals who suffer from major depressive disorder.”

In a paper posted on its Web site, the FDA cautions that recent press and medical- journal reports of suicides and attempted suicides by youngsters on antidepressants “are very difficult to interpret, in the absence of a control group,” because the same behavior is seen in children with major depressive disorders who are not treated with such drugs.

“The FDA has a difficult task ahead of it,” Mr. Brock said. “What needs to be sorted out is, ‘Is it the depression causing the suicidal behavior or is it the drug?’”

Related Tags:


This content is provided by our sponsor. It is not written by and does not necessarily reflect the views of Education Week's editorial staff.
Professional Development Webinar
Strategies for Improving Student Outcomes with Teacher-Student Relationships
Explore strategies for strengthening teacher-student relationships and hear how districts are putting these methods into practice to support positive student outcomes.
Content provided by Panorama Education
This content is provided by our sponsor. It is not written by and does not necessarily reflect the views of Education Week's editorial staff.
Classroom Technology Webinar
Transform Teaching and Learning with AI
Increase productivity and support innovative teaching with AI in the classroom.
Content provided by Promethean
Curriculum Webinar Computer Science Education Movement Gathers Momentum. How Should Schools React?
Discover how schools can expand opportunities for students to study computer science education.

EdWeek Top School Jobs

Teacher Jobs
Search over ten thousand teaching jobs nationwide — elementary, middle, high school and more.
View Jobs
Principal Jobs
Find hundreds of jobs for principals, assistant principals, and other school leadership roles.
View Jobs
Administrator Jobs
Over a thousand district-level jobs: superintendents, directors, more.
View Jobs
Support Staff Jobs
Search thousands of jobs, from paraprofessionals to counselors and more.
View Jobs

Read Next

Student Well-Being School Sports Participation Drops, Raising Concern About 'Physical Learning Loss'
But interest in e-sports and inclusive teams is rising.
5 min read
The Michigan City High School Girls Varsity Basketball team hosted a Future Wolves basketball camp for elementary and middle school girls on Saturday, March 5, 2022 at the high school.
The varsity girls basketball team at Michigan City High School in Michigan City, Ind., hosted a basketball camp for elementary and middle school girls last spring.
Kelley Smith/The News Dispatch via AP
Student Well-Being Biden's National Strategy on Hunger: What It Means for Schools
The administration seeks more access to free school meals and nutritious foods. But a universal free meals bill is stalled in Congress.
4 min read
President Joe Biden speaks during the White House Conference on Hunger, Nutrition, and Health, at the Ronald Reagan Building, Wednesday, Sept. 28, 2022, in Washington.
President Joe Biden speaks during the White House Conference on Hunger, Nutrition, and Health in Washington on Sept. 28.
Evan Vucci/AP
Student Well-Being Opinion Why Students Give In to Peer Pressure. Here’s How to Help Them Resist It
Punishments like suspension don’t solve behavior problems. These tools are more effective.
Geoffrey L. Cohen
2 min read
Images shows a stylized artistic landscape with soothing colors.
Student Well-Being Explainer The School Year Is Getting Hotter. How Does Heat Affect Student Learning and Well-Being?
Climate change will lead to more hot school days, and experts say schools are not prepared.
10 min read
With only open windows and fans to cool the room down, students enter their non-air-conditioned classroom at Campbell High School in Ewa, Hawaii, on Aug. 3, 2015. Most of Hawaii's public schools don't have air conditioning, and record-high temperatures have left teachers and students saying they can't focus because of the heat. Hawaii lawmakers are saying it's time to cool Hawaii's public schools. A proposal being considered by the House Committee of Finance would fund air conditioning for Hawaii Department of Education schools and expedite the process to get cooling systems installed in classrooms.
Only open windows and fans cooled the room as students arrived at Campbell High School in Ewa, Hawaii, in August, 2015. Most of Hawaii's public schools don't have air conditioning, even as research shows that heat can depress student learning.
Marco Garcia/AP