Education

Antidepressant Safety Concerns Are Increasing

September 24, 2004 1 min read
  • Save to favorites
  • Print

Could antidepressants be the cause of suicidal behavior in some children?

A statement released by the U.S. Food and Drug Administration last week suggests the answer is yes, signaling a major change in the agency’s position.

An advisory committee for the federal agency, which met Sept. 13 and 14, reviewed data about antidepressants at a two-day public hearing.

The statement, released two days after the committee’s meeting, recommends that any warning related to the increased risk of suicidal thoughts be applied to all antidepressant drugs.

In February, FDA officials asked drug manufacturers to place stronger warnings on the labels of 10 antidepressants to alert people to monitor patients closely for signs of suicidal behavior.

A controversial report released earlier this year in Britain concluded that antidepressants contributed to suicidal behavior in children. Drug manufacturers have disputed those findings.

Susan Bro, a spokeswoman for New York City-based Pfizer Inc., which manufactures the widely used antidepressant Zoloft, said that her company supports the agency’s February recommendation to monitor pediatric patients for suicidal behavior.

“Clearly, we share the FDA’s concerns to this vulnerable population,” Ms. Bro said. “Pfizer supports careful patient monitoring.”

The advisory committee is recommending that the FDA require drug companies to place “black box” labeling with bold type on information sheets that accompany the drugs. The labeling would discuss warnings and specific issues that physicians and patients should consider before beginning treatment.

But Pfizer officials are worried that grouping drugs without considering each company’s clinical data could jeopardize the availability of beneficial treatments.

“One of our major concerns in this dialogue is how overlooked the problem of major depression is, especially when left untreated,” Ms. Bro said.

Events

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.
Sponsor
Mathematics Webinar
Engaging Every Learner: Strategies to Boost Math Motivation
Math Motivation Boost! Research & real tips to engage learners.
Content provided by Prodigy 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.
Sponsor
Student Well-Being Webinar
The Ripple Effect: Mental Health & Student Outcomes
Learn how student mental health impacts outcomes—and how to use that data to support your school’s IEP funding strategy.
Content provided by Huddle Up
Artificial Intelligence K-12 Essentials Forum How AI Use Is Expanding in K-12 Schools
Join this free virtual event to explore how AI technology is—and is not—improving K-12 teaching and learning.

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

Education Quiz How Is Trump Changing School Discipline Rules? Take This Week’s Quiz
Test your knowledge on the latest news and trends in education.
1 min read
Education Briefly Stated: April 30, 2025
Here's a look at some recent Education Week articles you may have missed.
8 min read
Education Quiz What Is Trump’s New AI Plan for K-12 Schools? Take This Weekly Quiz
Test your knowledge on the latest news and trends in education.
1 min read
Illustration of tasks assisted with AI.
Canva
Education Quiz ICYMI: Moms for Liberty Launched Its Own University And More
Test your knowledge on the latest news and trends in education.
1 min read
Moms for Liberty co-founder Tina Descovich speaks before Republican presidential nominee former President Donald Trump at the Moms for Liberty annual convention in Washington, Friday, Aug. 30, 2024.
Moms for Liberty co-founder Tina Descovich speaks before Republican presidential nominee former President Donald Trump at the Moms for Liberty annual convention in Washington, Friday, Aug. 30, 2024.
Mark Schiefelbein/AP