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W arnings urged for depression fighters

Youth risk spurs call for strongest caution
Wednesday, September 15, 2004
Star-Ledger Staff

BETHESDA, Md. -- A panel of medical experts yesterday recommended the Food and Drug Administration issue the most severe type of warning for antidepressants, a popular group of medicines that has been linked to suicide.

The panel voted 15-to-8 for a so-called Black Box warning for children and adolescents after reviewing clinical-trial data that showed the drugs are twice as likely as a placebo to cause suicidal thoughts or behavior. The warning does not apply to adults.

"The purpose is to put physicians on notice that this group of drugs is a problem," said James McGough, a psychiatry professor at the UCLA School of Medicine during a two-day meeting here.

This type of warning, which is currently found on hundreds of medications, was chosen by the panel because it is prominently placed on package inserts in hopes of quickly capturing the attention of doctors and patients. The warning could affect current and future antidepressants.

"A Black Box is something that catches everybody's eye, because it's the first thing you see," Robert Temple, the director of the FDA's Office of Drug Evaluation, explained to the panel. "It's used for things that matter."

Although the FDA does not have to adopt a panel recommendation, the agency often follows its advice, and a decision is expected in a few months. The panel also suggested that the FDA issue Medication Guides, which are information sheets that are distributed to patients by their pharmacies.

The recommendations cap more than a year of escalating controversy over antidepressants, which generated more than $11 billion in retail sales last year and include well-known names such as Zoloft, Paxil and Effexor. Scientists, parents and politicians have weighed in on a debate that starts with a basic question: Do these drugs help or hurt?

The issue is complicated and emotional because many doctors and families say antidepressants are life-saving medicines for people suffering from depression. Any move, they argued, to restrict availability may rob patients of needed help.

Only one antidepressant, Prozac, is approved for use by people under age 18. But doctors are free to prescribe whatever drugs they want, a controversial practice known as off-label use. As a result, prescriptions to youngsters accounted for nearly 8 percent of the total written during the first six months of 2004, according to IMS Health, a market-research firm.

The issue was triggered last year by U.K. regulators who warned doctors not to prescribe the medicines to children. The furor intensified after it became known that pharmaceutical companies never fully disclosed clinical trials showing links to suicidal behavior.

Reaction yesterday was largely favorable.

One consumer advocate, Vera Sharav of the Alliance for Human Research Protection, described the panel recommendation as a "good first step," but continued to demand tighter standards for clinical-trial testing and disclosure of data.

Similarly, David Healy, a psychiatrist from the U.K. who has criticized drug makers for failing to disclose unfavorable data and has served as an expert witness in lawsuits against drug makers, said a Black Box "is the right thing and makes sense."

And Joseph Camardo, senior vice president for medical affairs at Wyeth, which sells Effexor, said the Madison-based drug maker was pleased. While Effexor showed the greatest link to suicide in the review, Wyeth hopes any warning would apply equally to all antidepressants, he said.

The vote followed a highly emotional session on Monday afternoon, when dozens of people described how a family member attempted or committed suicide while taking an antidepressant.

One parent, Lisa Van Syckel of Raritan Township, was angry the panel did not support a ban, and chastised the FDA for not releasing trial data sooner. Her teenage daughter attempted suicide while taking Paxil, a GlaxoSmithKline drug.

The panel yesterday briefly considered recommending a ban for anyone younger than 18, but the idea was shelved after several panel members indicated they would not support it.

A Black Box "will make prescribing more difficult," said Wayne Goodman, a University of Florida psychiatry professor who chaired the meeting. "And it will raise the threshold to prescribing."

The warning may also have the practical effect of limiting direct-to-consumer advertising, because such ads must contain information that is difficult to convey on television. These ads are blamed by critics for creating unwarranted consumer demand.

Last March, the FDA issued a public-health advisory instructing doctors to monitor their patients for signs of suicidal behavior or thoughts. That warning applied to adults and children; the new panel recommendation is targeted only at teens and children.

The agency also commissioned a team of Columbia University researchers to sift through clinical trial data from the drug makers. The goal was to identify, if possible, any reasonable links to suicide.

This week's meeting was held to review those findings, as well as an internal FDA review, which found that two to three of every 100 patients who are given an antidepressant can be expected to develop suicidal thoughts or behavior.

The reviews revealed weaknesses in the data that confounded panel members during much of yesterday's discussions. At times, the debate was little more than a series of statistical skirmishes as panel members sought to decipher the information.

Yesterday, FDA officials appeared relieved the panel took a strong step.

"I'm sure there will continue to be people who think we didn't act fast enough or were (not) critical enough," Temple said.

The controversy may not be over, though.

Congressional inquiries are under way, and momentum is building to require drug makers to register their clinical trials with a national registry. A hearing by a House panel is scheduled for next week on the FDA's handling of the issue.

Ed Silverman can be reached at (973) 392-1542 or

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