NEWS - US panel urged to back new antidepressant warning

[Guest guest]

SCIENCE NEWS

December 13, 2006

U.S. panel urged to back new antidepressant warning

By Richwine

WASHINGTON (Reuters) - Angry and grieving family members pleaded with

U.S. advisers on Wednesday to back strong new warnings on antidepressant

drugs, saying the risks of suicidal behavior seen in children also apply to

adults.

Psychiatrists, however, cautioned against tough language that could

scare patients from effective treatment for depression, a mental illness

that can lead to suicide. Millions of patients now take the drugs.

A Food and Drug Administration analysis found short-term therapy with

the newest antidepressants seemed to increase the chances of suicidal

thoughts and actions in adults up to age 25. The drugs appeared to reduce

suicidal behavior in older adults, particularly after age 65.

Officials said they were considering adding that information to a

current warning that states use of the drugs may trigger suicidal thoughts

and attempts in some children and teens.

Relatives of patients who killed themselves urged an FDA panel of

outside advisers to add a strong warning for adults of all ages. Some said

the agency should have acted years ago when the debate about suicidal

behavior first emerged.

Suzanne testified that her 40-year-old husband shot himself

in the head shortly after he started taking GlaxoKline Plc's Paxil.

" I hold you all responsible for his death, and I always will, "

shouted to FDA officials and outside experts seated around tables

in a hotel meeting room.

" I keep asking myself ... what was my husband thinking? How crazy did

you make him that morning that he would get up .. and do this to himself? "

she said.

Newer antidepressants include Paxil, Pfizer Inc.'s Zoloft, Eli Lilly

and Co.'s Prozac, and Cymbalta and Wyeth's Effexor. Sales topped $12.5

billion in 2005, according to data from health information company IMS

Health. Some of the drugs come in generic versions.

Psychiatrists said the warnings about suicidal behavior in children

and teens already had sharply reduced prescribing, which could put patients

at risk of killing themselves because they get no relief from their

depression.

" A much greater risk of disrupted lives and suicides ... exists with

untreated depression, " said Dr. Darrel Reiger, research director for the

American Psychiatric Association.

FDA officials said they would ask the advisory panel for input on its

analysis and plans to add information about the risk in adults to the drug

labels. The committee was not scheduled to take any votes.

The FDA review found the chances of suicidal thoughts or behavior

among adults younger than 25 " approaches that seen in the pediatric

population. " In clinical trials of nine antidepressants, 4 percent of

patients who took the drugs reported suicidal thoughts or behaviors,

compared with 2 percent who were given a placebo.

The new analysis of adult use spanned 372 clinical trials involving 11

antidepressants and almost 100,000 patients.

Pfizer has said it found no higher rate of suicidal behavior in adult

or pediatric patients who took Zoloft in short-term clinical trials. Lilly

said it was working with the FDA to better understand the safety and

effectiveness of antidepressants.

Glaxo said in June it added findings to the Paxil label from a study

showing young adults who took the drug in clinical trials were more likely

to report suicidal behavior than others who got a placebo. The company said

at the time it was hard to tell if the drug caused the behavior.

http://www.sciam.com/article.cfm?chanID=sa003 & articleID=905669063311D8A17BD6958C\

D353EEDD

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org