Authors

  1. Wallis, Laura

Abstract

Did FDA warnings about these drugs have unintended consequences for teens?

 

Article Content

In 2003 and 2004, the Food and Drug Administration (FDA) issued a number of health advisories stating that children and adolescents taking antidepressants might be at increased risk for suicidal ideation and behavior and in 2004 required that a boxed warning to that effect be added to the labeling of all antidepressants. Although the warnings were based on conflicting scientific studies, the possible link was nonetheless reported in the media. However, those warnings may have had an unintended and unfortunate consequence.

 

Not surprisingly, an abrupt decline in antidepressant use followed the FDA warnings, particularly among adolescents. Now, a long-term, nationwide study examining that drop's effect on suicidality shows that suicide attempts among adolescents and young adults increased in the years immediately after the FDA warnings.

 

Lu and colleagues studied 11 large health care organizations providing care to a diverse population of 10 million people across 12 U.S. states. In the second year after the warnings, there were increases in rates of psychotropic drug poisonings-considered a reliable proxy for suicide attempts-21.7% among adolescents (ages 10 to 17 years) and 33.7% among young adults (ages 18 to 29 years). No changes were found in completed suicide rates, though, which is a rare outcome in all age groups.

 

The FDA warnings were issued at a time when antidepressant use was on the rise across all age groups and, presumably, more young people were being treated for depression. But the sudden change in that trend doesn't seem to have been accompanied by an increase in the use of treatment alternatives, nor was there an increase in the monitoring of patients who were taking antidepressants, despite specific calls for both in the boxed warnings.

 

Medication and therapy is best. "Anytime someone seems suicidal, they need to be monitored, not just given medication," says Donna Sabella, director of global studies in the College of Nursing and Health Professions at Drexel University in Philadelphia and an AJN contributing editor. It's generally held that, in young people especially, a combination of medication and therapy is best for treating depression, says Sabella. "We have a whole arsenal," she says. "To leave out half of the equation is poor mental health practice."

 

The study can't provide a complete picture, of course. Sabella stresses the importance of being careful about correlation and causation, noting that suicide attempts were on the rise even as antidepressant use appeared to level off in young adults, suggesting that there were other factors at play.

 

Nevertheless, as the authors of the study note, well-intentioned FDA advisories can be "crude and inadequate" ways to communicate with the public-a situation only worsened by media frenzy-and the impact of such poor communication is clear. But Sabella says some of the blame belongs to health care providers.-Laura Wallis

 

REFERENCE

 

Lu CY, et al. BMJ. 2014 Jun 18;348:g3596