Concerned about studies that showed antidepressant drugs may be leading some youths to suicidal activity, the Food and Drug Administration on Monday issued a public health advisory telling doctors to be especially careful in prescribing them.
The agency, which has been overseeing studies into the effects of eight popular antidepressants on patients under 18, said the data do not clearly establish an association between the drugs and suicide. But it also said an increase in suicidal behavior in young people taking the drugs cannot be ruled out.
Thomas Laughren, the FDA’s team leader for psychopharmacological drugs, said the agency has found enough reason for concern to request additional information from the companies that make antidepressants, and to schedule an expert advisory committee hearing on the subject for February.
“We’re not saying these drugs can’t be used” with youths, Laughren said. “We’re saying one should proceed with caution.”
Only Prozac has been approved by the FDA for use in youths having shown an effectiveness that others have not yet shown but doctors often prescribe other antidepressants off-label for youngsters.
The concern over antidepressants and adolescent suicidal behavior was sparked in the summer in England, when health regulators warned doctors not to prescribe the antidepressant Paxil for people younger than 18 because data showed a heightened suicide risk. Those patients were diagnosed with major depression.
The FDA issued its own warning for Paxil soon after, and then asked the makers of eight antidepressants to give them more information about suicidal behavior by teens using their drugs. Last month, Wyeth Labs said studies on its antidepressant, Effexor XR, had found an increased incidence of “hostility and suicide-related adverse events, such as suicidal ideation [thoughts] and self-harm.”
Laughren said some of the data signaled a possible association between antidepressants and increased suicidal behavior but that it wasn’t specific enough to come to any firm conclusions. The agency has asked the companies for information on the 4,100 patients who participated in 20 clinical studies of young people taking antidepressants.
Detailed information on how many youths on antidepressants is unavailable, but experts agree the practice is on the rise. Mark Olfson, an associate professor at Columbia University’s College of Physicians and Surgeons, published a study last year that estimated that in 1996, 1 percent of children under 18 were using an antidepressant.
Meanwhile, Laughren, Olfson and others note statistics that the overall rate of teen suicide has declined in the past 15 years. Studies have not been done to test whether antidepressant use is contributing directly to the decline in teen suicides, but the researchers say a correlation is possible.