FDA orders antidepressant warning

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 youths.

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 depression.

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 2003.

TOUGHEST WARNING

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 prescription drugs.

''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 sugar pills.

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,'' Crawford said.

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 worldwide.

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 risks.

'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.''