advertisement
© 2004 American Academy of Pediatrics
AAP, FDA urge label changes for antidepressants
The American Academy of Pediatrics is urging manufacturers of 10 antidepressant drugs to swiftly revise their labels to include stronger cautions and warnings about the need to monitor patients for worsening symptoms of depression and the emergence of suicidal ideation, regardless of the cause of such worsening. The antidepressant drugs recommended for label changes include: bupropion, citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, escitalopram and venlafaxine. The only drug that has received approval for use in children with major depressive disorder is fluoxetine. The Academy's call for labeling changes follows a similar recommendation made by the Food and Drug and Administration (FDA) in a Public Health Advisory warning of the possible link between antidepressants and increased risk of suicide. "Stronger cautions and warnings will better inform pediatricians, psychiatrists, family physicians and other clinicians who prescribe these drugs to their patients," said AAP President Carden Johnston, M.D., FAAP. The agency advised clinicians, patients, families and caregivers of adults and children that they should closely monitor all patients being placed on therapy with these drugs for worsening depression and suicidal thinking that can occur during the beginning of treatment or when there is an increase or decrease in dose. The FDA further advised that these patients be observed for certain behaviors that are known to be associated with these drugs, such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania and mania. Physicians should be particularly vigilant in monitoring patients who may have bipolar disorder. The FDA has been closely reviewing the results of antidepressant studies in children since June 2003, after an initial report on studies with paroxetine (Paxil), and subsequent reports on studies of other drugs, appeared to suggest an increased risk of suicidal thoughts and actions in the children given antidepressants. On close examination of these initial reports, it was unclear whether certain behaviors reported in these studies represented actual suicide attempts or other self-injurious behavior that was not suicide-related. FDA has initiated a full review of these reported behaviors by experts in such evaluation. However, it is not yet clear whether antidepressants contribute to the emergence of suicidal thinking and behavior, the advisory stated. "Today's action by the FDA is yet another step in an ongoing process to ensure that all the drugs prescribed to children are safe and effective," said Dr. Johnston. "The AAP supports two federal laws that are increasing the testing of medicines prescribed to children: The Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, also known as the Pediatric Rule. Getting medication properly studied and having labels changed to reflect new safety, efficacy and dosing information as soon as possible is a critical goal in pediatric treatment. In this particular case, the FDA reviewed the current data and determined that a prominent label warning was warranted given concerns, but no concrete evidence, about the drugs contributing to suicides or suicidal thoughts." The public health advisory containing the new label warnings and cautions is available online at www.fda.gov/cder/drug/antidepressants/default.htm
  CiteULike  Connotea  Del.icio.us  Digg  Facebook  Reddit  Technorati  Twitter What's this?
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
