Panel urges broader suicide warning on antidepressants

AP

Thursday, December 14, 2006 -

Antidepressants increase the risk of suicidal behavior for people
up to age 24, the government said Wednesday. It plans new warning labels,
and says users of all ages should be closely monitored.

The label change proposed Wednesday would expand a warning now on the
antidepressants that applies only to children and adolescents.

The Food and Drug Administration presented its plan to update the drug
labels at a meeting of outside advisers on the issue. They endorsed
the plan.

The FDA also stressed that patients of all ages should continue to
be carefully monitored for signs of suicidal tendencies when they are
beginning treatment on the drugs.

Public reaction was split, with some saying the changes were overdue
and others arguing they could keep drugs from those who need them. (Dr.
Sanjay Gupta ponders the seeming contradiction. )

In emotional testimony illustrated at times by slides of family photos,
relatives of suicide victims pleaded for the new warnings.

Suzanne Gonzalez, shouting and in tears, goaded the panel to action,
telling the experts that her 40-year-old husband who had been taking
Paxil shot himself.

"I wake up every morning thinking, 'Oh my God, he's dead. He is
freaking dead.' Do you wake up and think, 'How many people are going
to die today because I am doing nothing?"' Gonzalez asked.

Still, mental health experts worry that additional warnings could curtail
use of the drugs and ultimately do more harm than good.

Dr. John Mann, a Columbia University psychiatrist, suggested simply
replacing the proposed expanded warnings with the recommendation that
doctors more closely monitor their patients.

"We can do more good by providing more treatment for depressed
children and adults," Mann said.

The FDA proposed the changes after completing a review that found use
of the drugs may increase the risk of suicidal thoughts and behavior
among young adults 18 to 24, as well as among younger patients.

Psychiatrists testified Wednesday that the 2004 addition of a warning
for children led to a falloff in antidepressant prescriptions being
written for patients under 18 -- and an increase in suicides in that
age group.

Still, overall use of antidepressants continues to grow, with nearly
190 million prescriptions dispensed in the United States last year,
according to IMS Health, a health care information company. That suggests
doctors have placed more weight on the long-term benefits of the drugs
than on any short-term risks, said Dr. Thomas Laughren, director of
the FDA's division of psychiatry products.

Expanding the "black box" or other warnings on the drugs
could dissuade patients from seeking or starting treatment, mental health
experts said. They warned that people with untreated depression -- about
half of those who suffer from the disease -- face an estimated 15 percent
greater likelihood of death by suicide.

Dr. Joseph Glenmullen, a Harvard Medical School clinical instructor
in psychiatry and author of "Prozac Backlash," said expanding
the warnings wouldn't scare off patients, but instead would allow them
to make informed choices.

The FDA recently completed a review of 372 studies involving about
100,000 patients and 11 antidepressants, including Lexapro, Zoloft,
Prozac and Paxil.

When the results were analyzed by age, it became clear there was an
elevated though small and short-term risk for suicidal thoughts and
behavior among adults 18 to 24, the FDA said in documents released ahead
of Wednesday's meeting of its psychopharmacologic drugs advisory committee.

The FDA's analysis of the multiple studies suggests an age-related
shift in the risk of suicidal thoughts and behavior associated with
treatment with the drugs. For instance, antidepressants seem to protect
against suicidal thoughts and behavior in adults 30 and older, with
the effect most pronounced in patients over 65.

The FDA said the increased risk could mean as many as 14 additional
cases of suicidal thoughts or behavior in every 1,000 children treated
with antidepressants. For adults 18 to 24, there could be four additional
such cases per 1,000.

In May, GlaxoSmithKline and the FDA warned Paxil may raise the risk
of suicidal behavior in young adults and added that to the drug's label.

"Anytime suicide is involved it is a tragic outcome. It is one
of the things that keeps us motivated to search for better treatments
because depression can be a fatal illness," GlaxoSmithKline spokeswoman
Mary Anne Rhyne said.