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Black box warnings

Panel votes to extend antidepressant black box warning to children and teens

Thursday, January 04, 2007 by: Ben Kage
Tags: black box warnings, antidepressants, children's health

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(NewsTarget) An advisory panel for the FDA recommended that warnings of suicidal thoughts and behavior in adults up to age 25 be put on antidepressant drug packaging, but a health advocate notes that few people pay attention to these warnings anyway.

Currently, antidepressant drugs such as Pfizer's Zoloft and Eli Lilly's Prozac and Cymbalta carry "black box" warnings -- the FDA's most severe warning for dangerous prescription drugs -- stating that the medications may increase suicidal thoughts or behavior in children and teens shortly after initial treatment. According to health information company IMS Health, sales of these drugs brought in $12.5 billion in 2005.

The recommendation was proposed in a 6-2 vote in favor, and also advised the FDA to note that the dangers seemed to drop after age 30 and the drugs even seemed to protect against suicidal behavior in older patients, particularly those older than 65. They also recommended the labels warn that untreated depression could lead to serious consequences, including suicide.

"We want to extend the age in the black box and at the same time not discourage treatment," said panel member Dr. Andrew Leon, a psychiatrist at Weill Medical College of Cornell University in New York. In 2004, after the FDA ordered warnings about antidepressants causing suicidal behavior in some youths, use of the drugs declined. While one analyst for the FDA estimated there could be 14 additional cases of suicidal behavior for every 1,000 patients younger than 18 -- and four cases for every 1,000 patients between 18 and 24 -- some psychiatrists claimed that suicide rates rose slightly after the number of prescriptions issued for antidepressants waned.

Before the recommendations were debated, family members of patients who had committed suicide while on antidepressants testified to the panel that strong warnings for the drugs should be applied to patients of all ages. Some said the first emergences of antidepressant-linked suicidal behavior should have spurred the FDA into action in the early 1990s.

"I hold you all responsible for (my husband's) death, and I always will," said Suzanne Gonzales, whose 40-year-old husband shot himself in the head soon after beginning treatment with GlaxoSmithKline's Paxil. Recently, GlaxoSmithKline has added information from a study that showed young adults on placebo were less likely to report suicidal behavior than those on antidepressants to their label.

Pfizer and Effexor maker Wyeth maintained that adult trials indicated no link between their drugs and suicidal thoughts or behavior, although Wyeth's Vice President for Neurosceince, Dr. Philip Ninan, said the company would support some type of warning about possible risks for such behavior in young adults taking any antidepressant.

"Black box warnings are health safety gimmicks that allow the FDA to avoid having to ban dangerous prescription drugs that should be banned," said Mike Adams, a consumer health advocate and critic of the overmedication of children and teens. "The warnings are all but ignored by doctors and patients alike. They serve no purpose other than allowing the FDA to disclaim responsibility for the hazardous side effects.

While the FDA usually follows recommendations from its advisory panels, Adams noted that this is not always the case. Earlier this year, the panel voted to require black box warnings on Ritalin after methylphenidate, the generic name for Ritalin, was implicated in 19 cases of sudden death. As noted in the Feb. 18 issue of New Scientist, the FDA decided to reject the recommendation.

"I have no doubt that if antidepressants were actually herbs, the FDA would declare them to be 'unsafe at any dose' and ban them from the marketplace," Adams said. "But because they are high-profit pharmaceuticals that earn billions of dollars for drug companies, the FDA keeps them on the market as long as possible, using black box warnings to excuse themselves from drug safety responsibilities."


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