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.
I love you.