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To: Biomaven who wrote (23477)	4/17/2007 6:28:32 PM
From: Biomaven	Respond to of 52153

Here's an example of how how an abundance of caution by the FDA (black boxes everywhere!) can probably do more harm than good: UPDATE 1-Antidepressants' benefits exceed risks - US study Tue Apr 17, 2007 4:27 PM ET (Adds FDA comments, paragraphs 5, 14,15) By Julie Steenhuysen CHICAGO, April 17 (Reuters) - The benefits of antidepressants for children and teens far outweigh the risk of suicide, and U.S. regulators should revise strong warnings that may have scared off some doctors and patients, researchers said on Tuesday. A wide-reaching review of studies on antidepressants in young patients showed the risk of suicidal behavior is smaller than previously thought and should be viewed in light of the relief these drugs can offer, the researchers said. "The benefits seem to be much stronger than the risks," said Dr. David Brent, a researcher at the University of Pittsburgh School of Medicine, whose study appeared in the Journal of the American Medical Association. The research calls into question "black box" warnings on the labels of antidepressants called selective serotonin reuptake inhibitors or SSRIs that caution of a higher risk of suicidal behavior among children and teen-agers. The U.S. Food and Drug Administration said there is no reason for a change in the labeling and said doctors are still free to prescribe the drugs to young patients. The FDA introduced the warnings on the most popular antidepressants in October 2004 after studies in the United States and Britain suggested the drugs may raise the risk of suicide in children and adults. Millions of Americans use antidepressants, which include Wyeth's <WYE.N> Effexor, Pfizer Inc.'s <PFE.N> Zoloft, GlaxoSmithKline Plc's <GSK.L> Paxil, Eli Lilly and Co's <LLY.N> Prozac and Forest Laboratories <FRX.N> Lexapro. MORE HARM THAN GOOD? "Clearly, their intent was to protect people, but you have to then re-evaluate whether your warning may be doing more harm than good," Brent said in a telephone interview. According to data from Medco Health Solutions Inc., the number of children 19 and under taking antidepressants fell by 13 percent from 2004 to 2005. Brent noted that suicide rates in adolescents have, at the same time, begun to rise. "That is after 10 consecutive years of a decline in the rate," he said. He pointed to a February study in the journal Pediatrics that found deaths from suicide in 10 to 19-year-olds rose 18.2 percent in 2004 from 2003. No other causes of child death increased during that period. "It is possible that people who would benefit from this medication are being frightened away," he said. But the FDA disagreed. "At this time nothing indicates a need for change in the 'black box' warning, which urges attention to patients starting treatment," said Dr. Thomas Laughren, director of the FDA's division of psychiatry products, in a statement e-mailed to Reuters. For the study, Brent and colleagues reviewed data from 27 major clinical trials assessing antidepressant use in 4,400 children and adolescents with major depressive disorder, obsessive-compulsive disorder and anxiety disorders. The analysis, funded by the National Institute of Mental Health, included data from an additional 700 patients not available when the FDA issued its warning. The study showed an increased risk for suicidal thoughts and attempts, but the size of the effect was smaller than in the FDA report. There were no completed suicides. Brent said young people on the drugs should be monitored closely and taken off them if they derive no benefit, but stressed that depression is the leading cause of suicide. "The risk of no treatment can be deadly," he said.

To: Biomaven who wrote (23477)	4/17/2007 6:46:41 PM
From: scaram(o)uche	Respond to of 52153

Almost any indication. About time! Your post gets to be the first one to a thread that I established some time ago, as it's a point that I intended to get to...... Message 23467685 :-) Add extensive phase IV's and much more, of course.

To: Biomaven who wrote (23477)	4/17/2007 7:09:08 PM
From: scaram(o)uche	Read Replies (2) \| Respond to of 52153

>> folks that claimed that Vioxx was a miracle drug for them compared with other NSAIDS << Makes perfect sense to me. I tolerate ibuprofen extremely well, but bleed from aspirin. Ibuprofen is now an effective first line defense, backed by the triptan stopper. Life in a gym rather than in a dark, quiet room. That combo has virtually given me freedom from debilitating headaches. Just coincidence, since it was the first and only triptan that I've ever used, but.... 40 years of pain wiped clean by a MERCK pain killer. Good example of the point you made, re. bringing the drug forward for an indication where patient need can be differentiated, and given that I mentioned "first and only" triptan.... frodo's approval for menstrual pain.