Tuesday, October 19, 2004

APA Responds to New FDA Warning on Antidepressants
Press release, in Adobe Acrobat format, from the APA - "The American Psychiatric Association believes antidepressants save lives. As part of a comprehensive treatment plan, antidepressants can be extremely helpful for many young people struggling with depression, an illness with significant long-term consequences, including an increased risk for suicide. We believe the biggest threat to a depressed child’s well-being is to receive no care at all. We restate our continued deep concern that a 'black box' warning on antidepressants may have a chilling effect on appropriate prescribing for patients. This would put seriously ill patients at grave risk..."  
  

Congress Hammers FDA Over Handling of SSRIs
Psychiatric News story - "Officials of the U.S. Food and Drug Administration (FDA) first suspected an increase in suicidal thoughts and behaviors linked to antidepressant use in children and adolescents in March 1996—eight and a half years ago. Yet no apparent action was taken by the agency until a pattern seemed to emerge in the first half of 2003. During a dramatic pair of hearings before the House Energy and Commerce Committee's Subcommittee on Investigations and Oversight last month, FDA officials were repeatedly put on the defensive as to whether there existed a conspiracy to cover up the link between the drugs and harmful behaviors. Unsatisfied with answers and explanations from agency officials during the second hearing, at least two committee members, Rep. Diana DeGette (D-Colo.) and Rep. Bart Stupak (D-Mich.), threatened to introduce legislation banning the prescribing of antidepressants to anyone under age 18 'if the FDA didn't act forcefully and swiftly to protect America's children.' "  
  

SSRI Prescriptions to Youth On Decline Since February
Psychiatric News story - "Conflicting emotions, combined with uncertain data, led to the FDA advisory committees' arriving at a split vote recommending black-box warnings for antidepressants. Now concerns about the drugs' safety could make a difficult situation worse. It did not take long for the data on prescriptions of antidepressants to children and adolescents to reflect shifting patterns as physicians reacted last spring to the potential connection between SSRIs and suicidal thoughts and behaviors. Now, serious concerns are being expressed about the probable impact of a "black-box" warning, jointly recommended last month by two Food and Drug Administration (FDA) advisory committees..."