FDA seeks antidepressant suicide warning

[Guest guest]

http://news./s/ap/20070503/ap_on_he_me/antidepressants_suicid

e;_ylt=AmHAOlAMunACxv62qIwKVNuKOrgF

FDA seeks antidepressant suicide warning

By ANDREW BRIDGES, Associated Press Writer Wed May 2, 10:51 PM ET

WASHINGTON - Young adults face an increased risk of suicidal thoughts

and behavior when they first begin taking antidepressants and should

be warned about the danger, federal health officials said Wednesday.

The Food and Drug Administration asked makers of the drugs to expand

its warning labels to include adults age 18-24. The labels already

include similar warnings for children and adolescents.

Eli Lilly and Co., the maker of Prozac, Zoloft manufacturer Pfizer

Inc. and other pharmaceutical companies said they would comply with

the FDA's request.

" We believe this step will help ensure that the millions of people

with depression who are young adults age 24 and under and their

families can make informed treatment decisions while minimizing the

fear and stigma associated with depression, " Eli Lilly said in a

statement.

Pfizer spokeswoman Shreya Prudlo said the company would update its

label, which she said already calls for close monitoring of patients

when they begin taking Zoloft. She added, however, " There is no

established causal link between Zoloft and suicide in adults, young

adults or children. "

The proposed labeling changes would note that studies have not shown

this increased risk in adults older than 24 and that adults 65 and

older taking antidepressants have a decreased risk of suicidal

thoughts and behavior.

The expanded warnings would emphasize that depression and certain

other serious psychiatric disorders are themselves the most important

causes of suicide.

" Antidepressant medications benefit many patients, but it is

important that doctors and patients are aware of the risks, " said Dr.

Galson, the FDA's drugs chief.

The FDA advises that patients of all ages starting on antidepressants

should be " monitored appropriately and observed closely " for

worsening symptoms, suicidal thoughts or behaviors or unusual changes

in behavior.

Still, any risks are small. For every 1,000 patients 18-24 treated

with antidepressants, the FDA would expect there would be five

additional patients who have suicidal thoughts or exhibit suicidal

behavior, said Dr. Laughren, who oversees psychiatric drugs

for the FDA. The FDA analysis was based on studies of 11

antidepressants in more than 77,000 patients.

The proposed changes came with the endorsement of FDA expert

advisers. Some experts have argued that the changes are overdue while

others maintain they could keep drugs from those who need them.

Last month, a comprehensive analysis of antidepressants for children

and teenagers found the benefits of treatment trump the small risk of

increasing suicidal thoughts and behaviors in some patients. The

Journal of the American Medical Association study also found that

risk is lower than what the FDA identified in 2004, the year the

agency warned the public about the risks of the drugs in children.

After that warning, doctors wrote children fewer prescriptions for

antidepressants, and U.S. youth suicides increased.

That suggests the warnings could have a net effect that is harmful if

they keep the drugs from patients who would benefit from them, said

Dr. Brent, a University of Pittsburgh School of Medicine

psychiatry professor and co-author of the JAMA study.

" When you have a black-box warning and within it you caution people

that the biggest risks are from the disease and not being treated,

people will still pay attention to the headline and not the small

print, " Brent said.

Laughren said the FDA's doesn't know if the previously strengthened

warnings led to the decrease in prescriptions or the increase in

youth suicides.

" These are data that are hard to reach any conclusion about in terms

of causality, but obviously it is something we are concerned about, "

Laughren said.