In 2004, the FDA added a "black box" warning to antidepressants prescribed to children and adolescents, advising prescribers that the drugs may increase suicidal thinking and behavior among younger patients and recommending increased monitoring during the first six to eight weeks of treatment.
According to a paper by M. David Rudd, PhD, Liliana Cordero and Craig J. Bryan, PsyD, in the August Professional Psychology: Research and Practice (Vol. 40, No. 4), the warning resulted in unintended consequences that might be partially responsible for an 18 percent increase in youth suicide rates from 2003 to 2004.
According to a September 2007 Centers for Disease Control and Prevention report, from 1990 to 2003, the combined suicide rate for people age 10 to 24 declined from 9.48 to 6.78 per 100,000 persons. But from 2003 to 2004, the rate increased from 6.78 to 7.32 per 100,000 people for that age group, the largest single-year increase from 1990 to 2004. More recent information is not yet available.
In the study, Rudd and his fellow authors surveyed non-specialist prescribing physicians and found that 91 percent erroneously believed there was a risk of death associated with the medications. That suggests that physicians misunderstood the black box and were less likely to prescribe antidepressants to young patients who would have benefited from medication, they said. The warning also might have led physicians to refer depressed patients to psychiatrists—and studies have shown that anywhere from 30 percent to 75 percent of patients do not show up to an initial mental health appointment, with the net result of fewer people getting care, Rudd says.
The warning may also have made parents less likely to bring children in for treatment, or be hesitant to fill prescriptions for the medications, he says.
In the public mind, it's now a common belief that young people who take antidepressants are at an increased risk for suicide, Rudd says.
"If you tell a parent, 'Here, I want to give you this medicine to help your child,' and 'Oh by the way, it increases the possibility that your child is going to kill himself,' not many parents are going to give that kid that medicine," Rudd says.
Rudd also notes that suicide rates for adolescents, which had decreased following the advent of antidepressants, have risen since the warning was added.
While not calling for changes to the warning, Rudd says there's a critical role for psychologists to play in the issue, particularly those psychologists working in integrated care settings: talking to physicians and parents about what the warning means, working with patients who won't take their medications and helping monitor youths on antidepressants for suicide warning signs such as sleep disturbance, anxiety and agitation.
"One thing's clear in the data: Combined therapies are most effective, in terms of medicine and psychotherapy," he says.
Not everyone agrees that the black box warning, in itself, has resulted in fewer prescriptions to children and teens. Morgan Sammons, PhD, dean of the California School of Professional Psychology, points out that suicide rates began trending upward in adolescents in 2003, the year before the FDA warning was published.
According to Sammons, another likely reason for the recent drop in antidepressant use in adolescents is that pharmaceutical companies are marketing them less aggressively since many have become available generically. Sammons adds that suicide rates are on the rise for all age groups, even though adults' antidepressant use is still rising significantly.
In his view, physicians were prescribing antidepressants for young patients too frequently, and not enough attention was given to psychotherapeutic approaches that have often been found to be equally effective for alleviating depression.
"What's needed is not to abandon their use, but to figure out how to integrate them with other treatments that are effective."