U.S. FDA urges caution over antidepressant use

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U.S. FDA urges caution over antidepressant use

Last Updated: 2004-03-22 12:50:51 -0400 (Reuters Health)

WASHINGTON (Reuters) - Patients taking antidepressants, including

children and teenagers, should be closely monitored for signs of

worsening depression and suicidal thoughts, U.S. health authorities said

on Monday.

The warning comes after a panel of experts last month called on the U.S.

Food and Drug Administration to issue stronger warnings about the

possible risks of suicidal behavior among children and teenagers taking

antidepressant drugs.

U.S. health officials are studying whether antidepressants can make

children and teenagers suicide-prone but have not yet reached a

conclusion.

" It is not yet clear whether antidepressants contribute to the emergence

of suicidal thinking and behavior, " the FDA said in a statement.

Questions about a possible link with suicidal behavior arose last year

when regulators were reviewing clinical trials of children who took

GlaxoKline Plc's Paxil.

The other antidepressants the FDA is evaluating include Forest

Laboratories Inc.'s Celexa, Solvay's Luvox, Akzo Nobel's Remeron,

Bristol-Myers Squibb's Serzone, Pfizer's Zoloft, Eli Lilly and Co.'s

Prozac, and Wyeth's Effexor.

Only Prozac, sold generically as fluoxetine, is approved for treating

pediatric depression.

The FDA advised patients and doctors watch for signs of hostility,

anxiety, insomnia and other behaviors that could signal worsening

depression and suicidal thoughts.

The agency asked manufacturers to change the labels of 10 drugs to

include stronger warnings about patient monitoring.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org