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A stronger warning on antidepressants about a potential suicide risk in children could scare people from getting the treatment they need, some psychiatrists say.
The warning was proposed last week by an expert panel of the Food and Drug Administration. It voted to recommend to the full FDA that all antidepressants carry a warning, highlighted in a black-lined box on their labels, about a small chance of suicide in children.
While the warning worries some, it comes as a heartening sign to others, including lawyers who have sued antidepressant makers. They see the proposed warning as belated acknowledgement by the FDA that the drugs have a risky side.
The black-box warning is the toughest safety warning regulators can put on a drug, and it would cover the entire class of antidepressants, prescribed 160 million times to Americans last year.
Few drugmakers have as much at stake in the issue as Eli Lilly and Co. The Indianapolis drugmaker dominated the antidepressant market in the 1990s with its product Prozac and this year launched a successor, Cymbalta, which carries the promise of becoming a top-seller.
The warning could hobble sales of antidepressants at a time when pressures mount on drugmakers to reduce prices of their products.
A call for a warning also undercuts the contention of Lilly and other drugmakers that antidepressants of the Prozac class don't cause suicidal behavior. Lilly, for one, has made the claim in defending against numerous product-liability lawsuits filed against it.
The full FDA probably will take several months to act on the recommendation, said spokeswoman Crystal Rice. The agency also may require a medical guide with the black-box warning to be attached to antidepressant prescriptions when they are handed out at pharmacies.
"It's far too early to try to put numbers to any impact" from the black-box warning, said Lilly spokesman David Shaffer. "We are just going to have to wait and see first whether the FDA decides this is appropriate."
Doctors say they already are seeing an effect.
"We already are hearing reports of pediatricians and primary care physicians who are increasingly reluctant to use these medications," said Dr. David Fassler, clinical associate professor of psychiatry at the University of Vermont College of Medicine.
Dr. John T. Walkup, an associate professor at the Children's Center at Johns Hopkins University School of Medicine, said he now often takes 30 minutes before therapy sessions start to explain the proposed warning to patients.
"People are saying, 'Should I do this, doctor, or not?' "
Walkup said he fears "there will be a whole group of patients who won't get treatment" because of fears raised by the warning.
In addition, some say the warning could expose physicians to greater legal liability.
By prescribing an antidepressant to a child, "You're taking a risk against a fairly in-your-face warning," said Dr. David Shaffer, professor of psychiatry and pediatrics at Columbia University. He is not related to the Lilly spokesman.
Only about 5 percent of U.S. antidepressant prescriptions are written for patients under 19, said John T. Boris, a health care analyst at Harris Nesbitt Inc. in New York.
That limits the negative financial effect of the warning on drugmakers, he said.
But drugmakers already face slowed sales growth for antidepressants. Sales grew just 5 percent for the first half of this year over last year, compared with double-digit growth during 2003, Boris said.
The FDA also has said it will analyze industry study data to see if a warning of suicide should be extended to adults.
If that happened, "obviously that would be another lagging effect" on antidepressant sales, Boris said.
The call for the black-box warning came after the FDA ordered drugmakers to submit all their studies of antidepressants on children and then reanalyzed them, looking for the rare cases of suicidal acts or other violent acts.
The review found that, on average, users of leading antidepressants were twice as likely as those given a dummy pill to take suicidal action.
The only FDA-approved drug to treat depression in children is Prozac. But doctors routinely use non-approved antidepressants for children.
Lilly no longer actively promotes Prozac, which went off-patent in 2001 and now is prescribed mostly in generic form.
"It's an unfortunate situation, really, that the drug we believe is most effective for pediatric use (for depression) has nobody pushing it," said Dr. Shaffer.
Lilly sold $645 million worth of Prozac last year, a far cry from its peak sales of more than $2.6 billion.
Andy Vickery, a Houston trial lawyer who has filed lawsuits on behalf of about a dozen children who committed suicide or harmed themselves after taking antidepressants, said the proposed warning vindicates his plaintiffs' charges that the drugs can harm a minority of users.
"It's huge," he said of the legal effect of the FDA's proposed warning. "Causation has been established. The mainstay of product-liability defense has been there is no proof of causation" that the drugs can cause users to turn violent.
Vickery was one of dozens of people who testified before the FDA panel that recommended the warning.
He told the committee about a 15-year-old Florida boy who was hospitalized in 2000 after having suicidal thoughts while taking the antidepressant Paxil. Hospital doctors increased the boy's dose of the drug, and he committed suicide soon after, said Vickery, who settled a lawsuit the boy's parents filed against Paxil maker GlaxoSmithKline.
If a black-box warning had existed at the time, "it probably would have saved his life," Vickery said of the boy. "The black-box warning would tell (doctors), 'By God this drug could be causing this. Take him off it.' "
Call Star reporter Jeff Swiatek at (317) 444-6483.
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