Sharp Decrease Seen After Reports of Risks
By Shankar Vedantam
Washington Post Staff Writer
Wednesday, February 2, 2005; Page A08
The number of American children taking antidepressant drugs fell sharply last year, after months of controversy over evidence that the medications increase the risk of suicidal thoughts and behavior among some children.
The steep decline among children is a dramatic reversal of a decade-long trend of soaring prescription rates for drugs such as Prozac, Paxil and Zoloft, and the pattern of the data suggests the numbers could fall even further.
Activists who had urged the Food and Drug Administration to require a black-box warning about the risks of the drugs said the drop reflects the better decisions that parents and physicians are making after being warned about the medications.
But medical groups such as the American Psychiatric Association and the American Academy for Child and Adolescent Psychiatry warned that the government had unwittingly unleashed an uncontrolled experiment that would cause many depressed children to go without treatment and ultimately lead to more suicides.
The turnaround in prescription trends was reported yesterday by Medco, which manages drug benefits for about 60 million Americans.
Various studies have shown a three- to tenfold rise in the use of antidepressants among children between 1987 and 1996, and an additional spike of 50 percent between 1998 and 2002. There was a further increase of about 9 percent between 2002 and 2003, but the new data revealed a 10 percent decline last year, said Robert Epstein, chief medical officer at Medco.
The decline was gradual at the start of the year but gathered momentum, Epstein said. While the raw data do not indicate why fewer children were getting medications, Epstein said the fall coincided with FDA warnings last year that culminated in October with a requirement that antidepressant manufacturers place the black-box label on their drugs.
That warning states that antidepressants increased the risk of suicidal thoughts and behavior in short-term trials involving depression and other psychiatric disorders. Doctors who use such medications "in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior."
Medical organizations said that language was making it increasingly difficult for general physicians and pediatricians to prescribe the drugs. The requirement to closely monitor patients presents a difficult hurdle, said Darrel Regier, director of the division of research at the American Psychiatric Association, because insurance plans often do not provide the same level of coverage for mental illness as for physical ailments.
Regier said that pediatricians renewing their malpractice insurance policies are being asked whether they prescribe antidepressants and that they face higher premiums if they say yes.
Epstein said the data indicated that psychiatrists as well as general physicians were writing fewer prescriptions.
At an APA news briefing announcing a new information site for parents and physicians -- ParentsMedGuide.org -- one member of the advisory committee that recommended that the FDA require a black-box warning said she would not have voted for it if she had known it would have such dramatic consequences.
"If I knew how much prescriptions would fall, I would not have voted in favor of the black-box warning," said Gail Griffith, who was the patient representative on the panel.
David Fassler, a child and adolescent psychiatrist in Burlington, Vt., said that while there may be some inappropriate prescribing for children, there are many more youngsters who need help and are going untreated. He and Regier said untreated depression is a far greater risk for suicide than any risks caused by the medications.
FDA spokeswoman Susan Cruzan said the agency would monitor the use of the drugs, including prescription trends. But asked whether the FDA would revisit the data, she said, "We just had a long, deliberative process. We had two advisory committee meetings, we worked with manufacturers to get the wording right."
With the exception of Prozac, none of the drugs involved is specifically approved to treat depression in children, and the majority of clinical trials of the drugs have not shown they are superior to placebos, or dummy pills. Part of the controversy last year focused on the fact that manufacturers had not informed physicians and the public about the negative trials.
"When parents and physicians were kept in the dark about the scientific evidence, they trusted the drug advertisements that promised wonderful results with no risk," said Vera Hassner Sharav, founder of the Alliance for Human Research Protection, a patients' rights organization.
"When given an opportunity to weigh the risks and benefits after learning the facts, parents are making responsible choices for their children," she said. "They are being cautious and skeptical, as they should be."