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FDA considers antidepressant risks for kids

September 15, 2004 By Erika Check This article courtesy of Nature News.

US agency advised to label drugs with stronger suicide warning.

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Advisers to the US Food and Drug Administration (FDA) have told the agency to issue a sweeping new warning about the risks of all antidepressants in children.

The warning would state that such medicines cause some children to try to commit suicide. This is a step up from warning labels adopted by the FDA in March, which say that antidepressant drugs are associated with a risk of suicide in children, but do not necessarily cause it. The warning would appear on all antidepressants on the market, as well as those approved in the future. The committee said antidepressants should also be sold with a guide that tells parents to monitor children on the drugs for suicidal tendencies.

The advisers came to their conclusions last night after a two-day hearing, in which they examined data from 24 clinical trials, as well as hearing passionate testimony from patients, parents and doctors who work with depressed children. The FDA convened the hearing on 13 September to ask its advisory committee how to interpret the clinical trials, which examined the effect in children and teenagers of nine antidepressant medications on five types of mental illness.

The FDA usually adopts its advisory committee's recommendations, but will discuss them internally before announcing a decision, says Robert Temple director of the Office of Drug Safety in the agency's drug evaluation centre.

Demanding disclosure

Those fighting the patients' corner have hailed the committee's recommendations as a major victory. They say that drug companies are downplaying the risks of a new family of antidepressants called selective serotonin reuptake inhibitors, or SSRIs.

Data requested by the FDA last year showed that children who took SSRIs in controlled clinical trials were more likely to think or act suicidally than children who did not take the drugs. But drug companies have failed to publish much of these data, and this has spurred lawmakers, doctors and journal editors to push for more openness about results.

"The big message from this is the importance of full disclosure," says Vera Hassner Sharav, president of the non-profit group known as the Alliance for Human Research Protection.

Strong warnings

The advisory committee was also concerned about the information drug companies distribute about their products. The committee voted 15 to 8 to tell the FDA to issue a "black box" warning, which is the strongest possible warning released by the agency. Drug companies must post black-box warnings prominently in any television or magazine advertisements for their products.

Some psychiatrists on the advisory committee said that black-box warnings might be the only way to get patients and doctors to pay attention to negative information about the drugs in the face of a deluge of advertisements. These ads tout the drugs' benefits even though most of the drugs have not been shown to help depressed children.

"It is almost a penalty for the intense direct-to-consumer advertising, which does play a huge role in driving sales for some of these drugs," said Bruce Pollock, a psychiatrist at the University of Pittsburgh School of Medicine.

Impeding treatment

Committee members who voted against the black-box warning were concerned that it could scare doctors away from using the medications in depressed children. As a result, these untreated children might kill themselves, they said.

"I fear the black box would impede access to treatment," said Matthew Rudorfer of the National Institute of Mental Health.

But other committee members pointed out that the clinical trials they examined show that most of the drugs do not work in children. And they were concerned by reports from the families who testified on 13 September that paediatricians had prescribed the drugs for relatively minor ailments, such as insomnia.

"That somebody would get Zoloft for insomnia is beyond anything I can understand," said child psychiatrist James McGough of the David Geffen School of Medicine at the University of California, Los Angeles. He says the purpose of the black-box warning would be "to inform physicians that this group of medicines can cause problems".

Company response

Most of the drug companies that make antidepressants have not yet responded to the advisory committee's recommendations. But one, Wyeth Pharmaceuticals of Madison, New Jersey, says that it supports some aspects of the committee's recommendations.

"Wyeth will discuss with the agency how to implement the recommendations of the committee to provide warnings and additional information to physicians, as well as patients and their parents," the company said in a press statement.

This article has been corrected from an earlier version; in the title, 'Congress' has been changed to 'FDA'.


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