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FDA strengthens suicidality warning on antidepressants.   Message List  
Reply | Forward Message #85 of 440 |
 
      The CBS Evening News (5/2, story 5, 0:30, Couric) reported, "The FDA has been warning for some time now that giving children antidepressants could actually raise their risk of suicide. Today the agency said it wants to expand that warning to include young adults. Right now labels for Prozac (fluoxetine) and other antidepressants carry a suicide warning for children and adolescents. The FDA says it plans to expand that to include adults between the ages of 18 and 24."
      NBC Nightly News (5/2, story 5, 1:50, Bazell) reported, "This is all about a rare side effect of these antidepressant drugs. Previous studies had shown that occasionally children, when they start taking the drugs, can have increased thoughts about suicide. Now new studies show that can also happen with young adults and that's the reason for the label change. However, the new label also points out that depression is the most common cause of suicide and these drugs are very good at eliminating the depression so most psychiatrists think they do far more good than harm."
      The Wall Street Journal (5/3, Dooren) reports that the FDA "said Wednesday it was expanding a 'black-box' warning on antidepressants to caution that the drugs appear to increase the risk of suicidal thinking in young adults up to age 25. The current warning, added in 2004, does say that antidepressants increase the risk of suicidal thinking and behavior in children and adolescents, but it doesn't include an age limit." Furthermore, the FDA said there "wasn't an increased suicidality risk in adults older than 24 and that, in adults ages 65 and older, 'taking antidepressants have a decreased risk of suicidality.' That language would also be reflected in the new warnings." Meanwhile, "many psychiatrists have complained the warnings are too strong and have prompted young people and their families from seeking treatment for depression and other mental disorders."
      The New York Times (5/3, Carey) reports that the FDA "also recommended that the labels remind doctors to balance this risk against the 'clinical need' for treatment and to mention that the drugs, which include well-known products like Paxil (paroxetine) and Zoloft (sertraline), are associated with no increased suicide risk in patients older than 25."
      Bloomberg (5/3, Larkin) reports that the FDA said "the makers of 36 antidepressants" must revise their labels "within 30 days." Meanwhile, although the FDA said that "scientific data hasn't shown an increased danger in adults older than 24," some consumer groups "have urged the agency to broaden the warnings. 'What is magic about the cutoff of 24?' said Sidney Wolfe, M.D., director of health research at Public Citizen in Washington, in a telephone interview. 'It doesn't make sense to pretend that the problem goes away once you get older.'"
      The Los Angeles Times (5/3, Gellene) reports the "action comes about five months after an FDA advisory committee recommended the warnings after finding a small increase in suicidal thoughts and behavior among young adults taking 11 commonly used antidepressants. The agency said five of every 1,000 patients age 18 to 24 were at increased risk."
      Notably, as reported in the April 18 briefing, a study in the Journal of the American Medical Association found that antidepressants "outweigh the risk of suicidal behavior." That study found that for every 100 patients being treated with the antidepressants, "fewer than one -- or 0.7 percent -- had an increased risk of suicidal thoughts," and there were "no completed suicides in any of the studies." Moreover, the analysis also found that "antidepressants were more effective than placebos" in treating children and teens.
      The Chicago Tribune /AP (5/3, Bridges) notes that since "2004, the year the agency warned the public about the risks of the drugs in children," physicians wrote children "fewer prescriptions for antidepressants, and U.S. youth suicides increased." The Tribune quotes Dr. David Brent, a University of Pittsburgh School of Medicine psychiatry professor and co-author of the aforementioned JAMA study, who said, "That suggests the warnings could have a net effect that is harmful if they keep the drugs from patients who would benefit from them. When you have a black-box warning and within it you caution people that the biggest risks are from the disease and not being treated, people will still pay attention to the headline and not the small print."
      HealthDay (5/3, Gardner) reports that "Wednesday's announcement is a follow-up to recommendations made in December by an FDA advisory committee." Dr. Thomas Laughren, director of the FDA's Division of Psychiatry Products, Center for Drug Evaluation and Research, admitted during a teleconference, "The risk [of suicidality] is quite small." However, he added, "We think it is a real risk and something we need to pay attention to." As for the increase in suicides, as noted in the JAMA study, Laughren said, "It would be speculation, but the coincidence of a decrease in prescribing and an increase in adolescent suicides after years of suicides coming down is a concern. I don't disagree with that."
      WebMD (5/3, DeNoon) reports that "CDC data shows an 8-percent increase in suicides among children age 10-14 and a 12 percent increase in the 15-19 age group. This is coincident with the finding of a decrease in antidepressants in these age groups. ... Laughren says if new CDC data continue to show declining antidepressant use and increased suicide among children, the FDA will reconsider its recommendations."
      Medpage Today (5/3, Bloom) also notes the FDA labeling change; and, the Wall Street Journal (5/3, Goldstein) includes a health blog on the new warning.


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Thu May 3, 2007 1:30 pm

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FDA strengthens suicidality warning on antidepressants. The CBS Evening News (5/2, story 5, 0:30, Couric) reported, "The FDA has been warning for some time now...
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