Monday, August 08, 2005

FDA Responds to Criticism With New Caution August 6 New York Times article - "Stung by a series of drug safety scandals, the Food and Drug Administration has in recent months issued a blizzard of drug-safety warnings and approval times for new drugs are slower. The agency is issuing twice the number of public advisories about drug risks as it did a year ago and adding five times as many black box warnings - its most serious alert - to drug labels. And drugs approved in the first half of this year took almost twice as long to get that approval as drugs approved in the same period last year. This new conservatism, a response to fierce recent criticism from Congress that the F.D.A. has failed to protect the public against drug dangers, has upset some doctors and drug makers..." [Viewing New York Times resources requires registration, which is free].  
  

Data Behind Antidepressant Advisory Don't Give Clear-Cut Answers  Psychiatric News story - "The FDA's most recent public health advisory regarding antidepressants appears to have been based on seemingly contradictory studies published earlier this year. The FDA's June 30 public health advisory concerning antidepressants was prompted, the advisory said, by 'several recent scientific publications' that suggested 'the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications.' FDA spokesperson Christine Parker told Psychiatric News that the advisory was prompted by 'two papers of particular interest.' Both appeared in the February 19 BMJ..." See also abstracts of the BMJ studies.  
  

FDA Alert Covers Cymbalta  Psychiatric News story - "In conjunction with its release of the public health advisory regarding increased risk of suicide in adults taking antidepressants, the FDA issued a separate FDA Alert involving duloxetine (Cymbalta) and suicidality in pediatric and adult patients. The alert largely echoes the language of the advisory, noting that the FDA is 'highlighting that adults being treated with any type of antidepressant medication, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior.' "