Antidepressant Warning for Kids. A caution against the use of antidepressants in children and adolescents did not have the dire consequences some feared. Doctors assumed a rise in teen suicide resulted from a sharp fall in antidepressant use among children and youth.
Depression is the leading cause of suicide, the third-largest killer of children and young adults, between those aged 10 and 24.
In 2004, the U.S. Food and Drug Administration (FDA) issued its strongest warning—a black box—on all antidepressant use in children and teens to draw attention to these medications’ possible risks. Researchers at Columbia University wanted to see the overall impact of the public health warnings and of the FDA’s black box warning.
They reviewed U.S. prescription data from before the FDA’s June 2003 warning to monitor adolescents taking GlaxoSmithKline’s antidepressant Paxil—the generic paroxetine hydrochloride—for signs of worsening depression and suicidal thoughts. Researchers also studied antidepressant use in the period leading up to the black box and the period 15 months following the warnings.
According to Dr. Mark Olfson of Columbia University Medical Center, the assumption that suicide spiked from reduced antidepressant use were mistaken.
Warnings that antidepressants might increase suicidal behavior in youth slowed rapid growth
Warnings that antidepressants might increase suicidal behavior in youth slowed rapid growth of these drugs but did not eliminate young people’s access, U.S. researchers said Monday, adding that while antidepressant use grew at an annualized rate of 36 percent before regulators’ 2003 warnings, growth flattened after warnings were issued.
“When the warnings first appeared, there was a great deal of concern among psychiatrists and other mental health professionals that these warnings would result in a precipitous decline in antidepressant use by young people, and as a result, youth with depression would have less access to treatment,” said Olfson, whose study appears in the Archives of General Psychiatry.
“What we found is the FDA warnings had a relatively moderate and targeted effect in slowing the growth of antidepressant use by children,” Olfson said. Recent studies suggest the drug warnings triggered an eight percent rise in suicide among youth and teens in 2004, the biggest one-year gain in 15 years.
U.S. and European regulators sent out a series of public health warnings in 2003 after clinical trials showed the drugs increased the risk of suicidal thoughts and behaviors in children and teens.
What they found was that antidepressant use in youth—aged six to 17—rose at an annualized rate of 36 percent; however, drug use in this group flattened following the 2003 warnings and did not significantly change following the black box in late 2004. Olfson said changes in antidepressant use have been confined to youth and young adults.
The American Foundation for Suicide Prevention said the FDA black box warnings and the drop in antidepressant prescriptions were what likely triggered higher suicide rates in young people in 2004. Olfson argued that preliminary figures suggest teen suicide rates in 2005 actually declined from 2004.
“This suggests that we need to look more carefully at this issue,” he said, adding that his study should address some concerns among physicians that the black box went too far. “There are still a number of physicians who feel the FDA overshot and that these warnings had a dramatic chilling effect,” Olfson said.