Monday, October 18, 2004

FDA Launches a Multi-Pronged Strategy to Strengthen Safeguards for Children Treated With Antidepressant Medications
October 15 FDA press release - "The Food and Drug Administration (FDA) today issued a Public Health Advisory announcing a multi-pronged strategy to warn the public about the increased risk of suicidal thoughts and behavior ('suicidality') in children and adolescents being treated with antidepressant medications. The agency is directing manufacturers to add a 'black box' warning to the health professional labeling of all antidepressant medications to describe this risk and emphasize the need for close monitoring of patients started on these medications. FDA has also determined that a Patient Medication Guide (MedGuide), which will be given to patients receiving the drugs to advise them of the risk and precautions that can be taken, is appropriate, and is in the process of developing one. "  
  

Depression Drugs to Carry a Warning
Washington Post story reprinted at Yahoo - " The federal government ordered yesterday that all antidepressant drugs carry a prominent "black box" warning to alert doctors that the medications increase the risk of suicidal thoughts and behavior among children and adolescents. Clinical trials showed that children taking antidepressants have a 4 percent risk of suicidal thoughts and behavior, compared with a 2 percent risk among children getting placebos, said regulators at the Food and Drug Administration..."  See also the AP story FDA Orders Strong Antidepressant Warnings and the New York Times story, F.D.A. Toughens Warning on Antidepressant Drugs. [Viewing New York Times resources requires registration, which is free].