Black Box Warnings In short-term studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (<24 years) taking antidepressants for major depressive disorders and other psychiatric illnesses This increase was not seen in patients >24 years;...
The FDA issued a black box warning in October 2004 about prescribing Prozac for children, and two years later extended the warning to include people as old as 24. In 2007, the FDA began requiring manufacturers of antidepressants to update warnings about the increased risks of suicidal thoughts ...
The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [seeBOX WARNINGandWARNINGS AND PRECAUTIONS] Serotonin Syndrome [seeWARNINGS AND PRECAUTIONS] Allergic Reactions and Rash [seeWARNINGS ...
Finally, we’re in agreement that there was indeed sufficient reason for the FDA black box warning on antidepressants, and we stand by their requirement of the warning to provide people with the most up-to-date and accurate information on this topic. So in that regard, the discussants on ...
Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [seeBOX WARNINGandWARNINGS AND PRECAUTIONS] Serotonin Syndrome [seeWARNINGS AND PRECAUTIONS] Allergic Reactions and Rash [seeWARNINGS AND PRECAUTIONS] Screening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania [seeWA...