Black Box Warning
In October 2004, the U.S. Federal Drug Administration (FDA) issued what is known as a “black-box” warning stating that certain antidepressants, when used in young people 24 years old and under, could increase their risk for suicidal thoughts and behaviors. The FDA noted that there was no association found between antidepressant use and suicidal thoughts and behaviors in adults over the age of 24. This black box warning, which is the most serious type of warning that can be issued regarding a prescription medication, was ordered following a thorough review of all available clinical trials, including unpublished ones, regarding the use of antidepressants in children and adolescents. The study included a total of 24 short-term trials of nine different antidepressants used in over 4,400 child and adolescent patients. In addition, there were 295 short-term trials of 11 different antidepressants involving 77,000 adult patients. While the risk of suicidality varied between drugs, the pattern of seeing increased suicidality in young people remained true for almost all drugs studied. It should be noted that no suicides actually occurred among the young people studied. Although there were some suicides among the adults studied, the numbers were too few for any conclusions to be drawn about whether the antidepressants used were a causal factor. For more mental health resources, see our National Helpline Database. It is also important to remember that depression itself is also a known risk factor for suicide and cannot be ruled out in these cases. The black box warning further suggests:
In addition, families and other caregivers should be instructed to contact the patient’s physician or another appropriate medical professional in the event that any problems occur.Patients of all ages should be monitored closely when they begin treatment with an antidepressant.They should be watched for any signs of worsening depression, increased suicidality, or changes in behavior.
Impact of the Warning
The FDA’s decision was not without controversy. There were unintended consequences of the FDA decision and the research itself was criticized due to methodological issues. Research has shown that there was a decrease in both depression diagnoses and antidepressant prescription rates in the wake of the FDA’s decision to include the black box warning. Another concerning trend was a resulting increase in psychotropic-drug poisonings. This may indicate an increase in suicide attempts, although whether these poisonings were accidental or intentional is not clear.
What to Watch For
In particular, the FDA recommends that a healthcare provider be contacted if you—or a person who you are caring for—experience any of the following:
Aggression, anger or violence Any other unusual changes in mood or behavior Extreme increases in activity or talking (signs of mania) Feelings of agitation or restlessness Impulsiveness New or worsening anxiety New or worsening depression New or worsening irritability Panic attacks Problems with sleeping Suicide attempts Thoughts of suicide or death
While a black box warning might cause some to feel concerned, they should be aware that the benefits to be obtained from treating depression with an antidepressant greatly outweigh the risks in the majority of cases. Untreated depression is quite serious and is much more likely to lead to suicide than is an antidepressant.
