- Suicide Prevention, Awareness, and Support is a 501c3 NON-PROFIT Organization and Website Suicide Survivors Forum - Click for Info!

FDA Advisory Recommendation: 'Black Box' Warning (Highest Warning) for Antidepressants Prescribed to Children and Teens

FDA Advisory Recommendation: 'Black Box' Warning (Highest Warning) for Antidepressants Prescribed to Children and Teens

by Kevin Caruso

September 16, 2004

After a two-day hearing, two U.S. Food and Drug Administration advisory committees have recommended that packages of antidepressants carry a "black box" warning - which is the highest FDA warning level -- indicating that the drugs can increase suicidal tendencies in children and adolescents.

A "black box" warning is so-named because the warning information is conspicuously circumscribed by a black box.

Numerous accounts of suicide attempts and suicides in children and teens have been attributed to the drugs. Yet other accounts have shown that many children and teens have recovered from depression because of them. Thus, a sharp division has existed in the ongoing debate about the safety and usefulness of the drugs in young people.

The 23-member advisory panel, which included psychiatrists, pediatricians, pharmacists, and statisticians, decided against an outright ban on the drugs, instead voting 15 to 8 in favor of "black box" warnings. (It should also be noted that in December 2003 Great Britain banned all antidepressants except Prozac for use in children and teens.)

The most poignant part of the two-day advisory-panel hearing occurred when many parents who lost their children to suicide because of the drugs testified.

In addition to the testimonies, the advisory panels used information from a just-released Columbia University study that found that 2% to 3% of children and teens on antidepressants experienced an increased risk of suicidal behavior or though compared with young people who took placebos.


It should be noted that antidepressants have helped many children and teens overcome their depresssion and suicidal thoughts, so the option of taking them should at least be explored; but proceed with great caution and consider all other options before making a decision.

And conduct as much research as possible. You want to be extremely knowledgable about antidepressants. Know all of the risks.

And if a phsychiatrist recommends antidepressants, you may want to get a second or even a third opinion from other psychiatrists.

And please monitor your child as closely as possible if you do allow him or her to take antidepressants and immediately report any significant change in behavior to the psychiatrist.

The decision as to whether or not your child takes antidepressants will be up to you and your child -- do not let anyone force something upon you that you do not want to do.

And make sure that all of your questions are answered before you allow your child to take antidepressants.

And if you do not like the psychiatrist who is treating your child, consider finding another one.

Again, conduct as much research as possible, monitor your child very closely, and do not hesitate to get another opinion or change psychiatrists

If you or someone you know is suicidal, please go to the Home Page of this website for immediate help.

Thank you.

I love you.

Take care,

Kevin Caruso

Free Newsletter!
Enter Your Email:

Disclaimer and Terms of Use: is provided for informational and educational purposes only; is not intended to diagnose or treat suicidal individual; and is not intended to constitute medical advice. While care has been taken in the preparation of the information contained on, all information is provided on an "as is" basis without any representation, warranty or condition, whether express or implied, statutory or otherwise, as to: quality; accuracy; completeness; legality; reliability; efficacy; or fitness for any particular purpose. Anyone using this information does so at his or her own risk, and by using such information agrees to indemnify and its content providers from any and all liability, loss, injury, damages, costs and expenses (including legal fees and expenses) arising from such person's use of the information and resources on this website. Anyone who is suicidal should call 911 now and receive help from trained mental heath professionals.