Friday, October 15, 2004

The Black Box

The FDA just released the contents of the new black box labels for antidepressants. I included the whole thing, just for shits and giggles.

"McMan’s Depression and Bipolar Weekly

Breaking News Oct 15, 2004

FDA Implements Black Box Warnings on Antidepressants for Kids

The FDA has directed the manufacturers of all antidepressants to add a "black box" warning to their product labeling that describes the increased risk of suicidality in children and adolescents given these drugs. A "black box" warning is the most serious warning placed in the labeling of a prescription medication, but does not ban physicians from prescribing the drug to children and adolescents.

The warning reads:

Suicidality in Children and Adolescents

Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of [Drug Name] or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. [Drug Name] is not approved for use in pediatric patients except for patients with [Any approved pediatric claims here]. (See Warnings and Precautions: Pediatric Use)

Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of nine antidepressant drugs (SSRIs and others) in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events on drug was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.


The FDA has mandated additional product labeling changes that include:

• All pediatric patients should be observed closely for clinical worsening, suicidality, and unusual behavior, especially during the initial months of treatment or during dose changes. At least weekly face-to-face contact is advised between physicians and patients or family members or caregivers during the first four weeks of treatment, biweekly visits for the next four weeks, then at 12 weeks, and as clinically indicated beyond that.

• Anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness), impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have not been causally linked to antidepressant use, “there is concern that such symptoms may represent precursors to emerging suicidality.”
• Consideration should be given to changing the treatment regimen or discontinuing the medication in patients whose depression worsens or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality.
• Families and caregivers of pediatric patients on antidepressants need to monitor patients for unusual changes in behavior, agitation and other symptoms, as well as the emergence of suicidality, and report these symptoms immediately to health care providers.
• Rule out bipolar disorder to the extent possible. “Prior to initiating treatment with an antidepressant, patients should be adequately screened to determine if they are at risk for bipolar disorder.”

The FDA has also advised that a user-friendly patient medication guide will be included with every prescription or refill."