In 2004, the Food and Drug Administration (FDA) issued a public warning about the increased risk of suicidal thoughts and behavior seen in children and adolescents taking popular antidepressant medications such as Prozac and Zoloft. After a review of all available clinical trials, the FDA directed drug manufacturers to add the dreaded "black box" label to their products to describe these increased risks. In 2006, the warning was expanded to include patients up to age 25.
A black-box warning appears on medication containers in bold print with a black outline. Although it doesn't prohibit the use of antidepressants in children and adolescents, it does warn of the risks involved and encourages prescribers to balance those risks with clinical need.
The widespread coverage of the FDA's decision, along with the deterrent of the black labels themselves, has resulted in a drop in antidepressant prescriptions—a development that could prove to be far more dangerous than the threat posed by the medications, says UAB child and adolescent psychiatrist James T. Cullinan, D.O.
Cullinan argues that clinicians, families, and patients need to understand the nuances behind the studies cited by the FDA so they can make decisions that are in the best interest of those struggling with depression.
First, he says, even though the studies showed that suicidal thinking and behaviors doubled with the use of some medications, and "that got everyone excited and worried," it's not the whole story. Suicidal thinking and behaviors increased from 2 percent in patients taking a placebo to 4 percent in patients taking active medication. "But there were zero suicides," he points out.
Cullinan says that in the year after the FDA issued its warning in 2004, prescriptions dropped by almost 10 percent—and adolescent suicides increased 8 percent. "That's not suicidal thinking," he points out. "That's actual, completed suicides. Suicide is the third leading cause of death for teenagers. Not treating depression can be a much more dangerous option."
Cullinan says that the increased risk does make it important for physicians to see patients more frequently if they are taking antidepressants. The need for close monitoring, in fact, may be one of the reasons that some doctors are less likely to prescribe antidepressants now.
Contrary to what one might expect, most prescriptions for these medications are not written by psychiatrists. "Pediatricians still constitute the greatest number of people prescribing them," notes Cullinan. "But they shouldn't just give out samples or write a prescription with three refills. You have to monitor these patients carefully, especially at the beginning of treatment. And some primary-care doctors may not have the ability to see people with depression once every week or two weeks."
Even if practitioners have that ability, Cullinan points out, insurance companies may not cover the cost of these extra visits, thereby limiting patients' accessibility to the medications.
Despite the concerns about antidepressants for children and adolescents, Cullinan is adamant that they have their place. "Depression is serious business, and if you ignore it, it's not necessarily going to go away. It can get worse and result in a very bad outcome. Treatments are available, and if doctors carefully monitor their patients, the risks can be greatly minimized."