The federal government ordered drugmakers Friday to include a
strong warning on the labels of all antidepressants linking the
drugs to an increased risk of suicide or suicidal thoughts among
The U.S. Food and Drug Administration's action comes amid
swirling controversy over the effectiveness and safety of more than
two dozen medications prescribed by doctors to treat clinical
Advocates say such drugs save the lives of children by
alleviating a dangerous mental illness. Critics say they have not
been proven effective in treating depression among children, and now
are linked to an increased risk of suicidal thinking.
In recent years, federal regulators have sought to balance the
risks of leaving depression untreated with medication against the
risk associated with taking the drugs. At a September Congressional
hearing, one parent said the ''blood'' of her daughter, who had
hanged herself last January, was on the government's hands.
''We are talking about children, one of our most precious
resources,'' said Russell Katz, director of the FDA's Division of
Neuropharmacological Drug Products. ''Depression in children is a
very serious condition. We owe these children and adolescents with
depression the right answer,'' Katz said.
Dr. Sandra Kweder, acting director of the FDA's Center for Drug
Evaluation and Research, called the agency's vigilance in studying
the drugs' risks ''unprecedented.'' The agency has issued four
public health advisories on pediatric antidepressant use since
FDA officials ordered drugmakers to include a ''black box''
warning to health professionals. The warnings are the most serious
such cautions the government can require for the labeling of
''Antidepressants increase the risk of suicidal thinking and
behavior in children and adolescents with major depressive disorder
and other psychiatric disorders,'' the warning says. ``Anyone
considering the use of [such drugs] in a child or adolescent must
balance this risk with the clinical need.''
A total of 24 clinical trials, which involved more than 4,400
patients, showed that children or adolescents taking antidepressants
were at greater risk of experiencing suicidal thoughts during the
first several weeks of treatment than patients taking placebos, or
None of the patients in clinical trials killed themselves.
FDA officials also announced they will produce a pamphlet for
parents or other consumers who are considering the use of
antidepressant medication for children.
BEHIND THE DECISION
Dr. Lester M. Crawford, acting FDA commissioner, called the new
initiative the result of an accumulation of new scientific study, as
well as a response to the growing demands of consumers.
''Our conclusions are based on the latest and best science,''
Suicide is the third-leading cause of death among children aged
10-19, experts say.
Only one antidepressant drug, Prozac, is approved by the FDA as
safe and effective for use among children. The first of the
so-called ''new generation'' of antidepressants to be approved in
the U.S., Prozac is now taken by more than 40 million people
Dr. Eugenio Rothe, director of the child and adolescent
psychiatry clinic at Jackson Memorial Hospital, called the FDA's
actions Friday a welcome development.
Often, Rothe said, psychiatric drugs are prescribed by
pediatricians who do not have the same breadth of knowledge as
trained psychiatrists -- and may not be informed of all the
'This points to the need for more research on children's and
adolescents' mental health,'' said Rothe, who is also a professor of
pediatric psychiatry at the University of Miami.
Sara Fritz, a Washington, D.C. woman whose 12-year-old son hanged
himself in October 2000, also praised the FDA on Friday for issuing
its warning. Doctors should be aware of all the risks when
prescribing drugs to depressed children, she said.
SEEKING A BALANCE
But she also expressed grave concerns that some doctors or
parents may misinterpret the new warnings and forgo the use of drugs
that can save lives.
Fritz's son, Daniel Kidney, was being treated by a psychologist
and neurologist for attention deficit/hyperactivity disorder. She
now believes her son's severe depression went unrecognized, and
Daniel may have been helped by treatment with an antidepressant
drug, along with therapy designed to combat the depression.
''The only thing I am worried about is that this warning may
discourage people from seeking treatment for their children,'' said
Fritz, 59, is a retired journalist who is writing a book about
children's mental health. ``That is a very risky thing.''