FDA Beefs Up Antidepressant Safeguards for Children

October 15, 2004

• Black Box Warning Linked to Suicide Spike • Study Finds Lessened Suicide Risk in Young Adults on Antidepressants • Antidepressant Benefits May Outweigh Suicide Risks: Study • Firearms Stored Less Safely in Homes With Older Children • Study Links Anti-Depressants, Youth Suicide • Study Suggests Antidepressant-Suicide Link • FDA Issues Suicide Warning on ADHD Drug • Study Finds Stronger Link Between Paxil And Suicide • Former Prozac Users Slam FDA • FDA Updates Analysis of Prozac in Children • FDA Beefs Up Antidepressant Safeguards for Children

Concerned about the increased risk of suicidal thoughts and behavior in children and adolescents being treated with antidepressant medications, the government is directing pharmaceutical companies to toughen its warnings to doctors.

The Food and Drug Administration is directing manufacturers to add a "black box" warning to the health professional labeling of all antidepressant medications to describe this risk and emphasize the need for close monitoring of patients started on these medications. FDA has also determined that a Patient Medication Guide, which will be given to patients receiving the drugs to advise them of the risk and precautions that can be taken, is appropriate, and is in the process of developing one.

"Today's actions represent FDA's conclusions about the increased risk of suicidal thoughts and the necessary actions for physicians prescribing these antidepressant drugs and for the children and adolescents taking them. Our conclusions are based on the latest and best science. They reflect what we heard from our advisory committee last month, as well as what many members of the public have told us," said Dr. Lester M. Crawford, Acting FDA Commissioner.

In letters issued October 15, FDA directed the manufacturers of all antidepressant medications to add a "black box" warning that describes the increased risk of "suicidality" in children and adolescents given antidepressant medications and notes what uses the drugs have been approved or not approved for in these patients.

FDA's letters to the manufacturers also discuss other labeling changes designed to include additional information about pediatric studies of these drugs. These labeling changes are applicable to the entire category of antidepressant medications because the currently available data are not adequate to exclude any single medication from the increased risk of "suicidality."

Prozac is currently the only medication approved to treat depression in children and adolescents. The analyses of the placebo controlled trials in children and adolescents summarized in the revised labeling are based on studies of five selective serotonin reuptake inhibitors (SSRIs) (Celexa, Prozac, Luvox, Paxil and Zoloft) and four "atypical" antidepressants (Wellbutrin, Remeron, Serzone and Effexor XR). In these studies, there was no reported case of a suicide.

A "black box" warning is the most serious warning placed in the labeling of a prescription medication. Advertisements that serve to remind health care professionals of a product's availability (so-called "reminder ads") are not allowed for products with "black box" warnings.

Until now, only ten drug products approved for children contained a black box warning about their use in children. The new warning language does not prohibit the use of antidepressants in children and adolescents. Rather, it warns of the risk of suicidality and encourages prescribers to balance this risk with clinical need.

FDA said it recognizes that depression and other psychiatric disorders in pediatric patients can have significant consequences if not appropriately treated. The new warning language recognizes this need but advises close monitoring of patients as a way of managing the risk of suicidality.

The second element of the agency's strategy is a Patient Medication Guide, an FDA-approved user-friendly information for patients. MedGuides are intended to be distributed by the pharmacist with each prescription or refill of a medication. FDA will work with the manufacturers of antidepressant medications to make the MedGuides available as soon as possible.

In addition, FDA said it intends to work with manufacturers to implement "Unit of Use" packaging for all antidepressants as a means of ensuring that patients receive a MedGuide with every prescription or refill. "Unit of use" packaging is a method of preparing a medication in an original container, sealed and pre-labeled by the manufacturer, and containing sufficient medication for one normal course of therapy.

Report Your Experience
If you've had a bad experience -- or a good one -- with a consumer product or service, we'd like to hear about it. All complaints are reviewed by class action attorneys and are considered for publication on our site. Knowledge is power! Help spread the word. File your consumer report now.

Follow us on Twitter.

Back to the top |

Terms of Use Your use of this site constitutes acceptance of the Terms of Use

Advertisements on this site are placed and controlled by outside advertising networks. ConsumerAffairs.com does not evaluate or endorse the products and services advertised. See the FAQ for more information.

Company Response Welcome If complaints about your company appear on our site, we welcome your response. Please see the Response Form for more information.

For more information, see the FAQ and privacy policy. The information on this Web site is general in nature and is not intended as a substitute for competent legal advice.  ConsumerAffairs.com Inc. makes no representation as to the accuracy of the information herein provided and assumes no liability for any damages or loss arising from the use thereof. 

Copyright © 2010 ConsumerAffairs.com Inc.  All Rights Reserved.    The contents of this site may not be republished, reprinted, rewritten or recirculated without written permission.