Dr. Fassler: Yes, the hearings took place in an emotionally charged environment. Parents testified, telling powerful and tragic stories about kids who had committed suicide. There was extensive media coverage. Based on the data presented at the FDA hearings, there was no evidence that these medications actually increase the risk of suicide in children and adolescents, but the media painted a different picture. For example, The New York Times reported, “FDA Links Drugs to Being Suicidal.” The headline in the Washington Post read, “FDA Confirms Antidepressants Raise Children’s Suicide Risk.” In the end, the Advisory Committee voted 15 to 8 in favor of imposing a black box warning on all antidepressants, and the FDA subsequently followed that recommendation.

TCPR: Why do you think the FDA approved the warning, given the evidence was so ambiguous?

Dr. Fassler: It’s my sense that the FDA recognized that the data on suicidal thinking and behavior was weak, at best. I believe they acted, in part, because of the relative lack of efficacy data for these medications, particularly when used in the treatment of depression. The data on use in anxiety disorders was more convincing.

TCPR: Do you think antidepressants are helpful in children?

Dr. Fassler: I think these medications can be helpful for some, but not all, children and adolescents who suffer from depres- sion or anxiety disorders. They’re generally most effective when used as a component of a comprehensive treatment plan. I also think that it’s difficult to extrapolate from short term trials to actual clinical practice, where children and adolescents typ- ically have multiple comorbidities and are often treated for a more extended period of time.

TCPR: How has the black box warning affected clinical practice?

Dr. Fassler: There was a fairly dramatic shift in practice patterns throughout the country. The FDA initially recommended a monitoring schedule that was pretty unrealistic: Once a week for 4 weeks, every two weeks for next four weeks, then at 12 weeks. This didn’t fit into reality of pediatric practice, and pediatricians and other primary care physicians became particularly reluctant to use these medications. The APA and the Academy of Child and Adolescent Psychiatry went back to the FDA and argued that there was no data to support this specific schedule, and it was eventually removed. Nonetheless, the decline in prescriptions was precipitous. Studies suggest that in 2003, 60% of kids diagnosed with depression received an SSRI, and by 2005 the figure had dropped to below 30%.

TCPR: Does this mean that these kids are being referred to therapy instead of getting medications?

Dr. Fassler: Unfortunately, no. The research actually suggests that fewer children and adolescents are being diagnosed with depression and referred for treatment of any kind. Of significant concern, we’ve also seen the first increase in the adolescent suicide rate since the early 1990s, an increase which corresponds to approximately 300 actual deaths per year, in the U.S. 

TCPR: Is this caused by the decline in antidepressant prescriptions?

Dr. Fassler: It’s too early to tell if the increased suicide rate is a direct result of the reduced use of SSRI antidepressants. There are other potentially intervening variables, including access to firearms, enhanced reporting, and the overall availability of mental health services. However, the trend is clearly of significant concern. Given the information currently available, it would seem appropriate for the FDA to reconvene the Advisory Panel to review recent studies and to consider the public health consequences of the black box warnings. I think the FDA has an obligation to monitor the impact of their regulatory decisions and to make modifications, as appropriate, based on subsequent data and research findings.

TCPR: At this point, what are your monitoring recommendations for psychiatrists starting children on antidepressants? 

Dr. Fassler: There’s no one schedule or approach that’s appropriate for all kids. For some, it’s best to see them weekly or biweekly until they’re relatively stable. For others, it may make more sense to see them less frequently, but to have regular telephone contact with their parents and other members of the treatment team. Ultimately, the approach to monitoring should be based on your clinical assessment and individualized to the needs of the child and family.[Ed. Note: The American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry have pro- duced a free guide to help answer parents’ questions about SSRI antidepressants. The guide is available at www.ParentsMedGuide.org.]