Revised requirements for antidepressant labels that would omit references to a causal link between the drugs and suicide in children and adolescents have drawn mixed reactions.
“I think it's good that the FDA has shied away from making a blanket statement about causality,” said Adelaide Robb, M.D., medical director of inpatient psychiatry at Children's National Medical Center in Washington.
But she says the black box warning is extreme.
“I wish the black box wasn't there,” she told FAMILY PRACTICE NEWS. “I think it is overly cautious, and I think it will steer people away from [prescribing] treatment that can be very effective.”
The originally proposed wording for the labeling said, “A causal role for antidepressants in inducing suicidality has been established in pediatric patients.” However, before the new labeling was implemented, the Food and Drug Administration decided to soften the language.
Current wording reads, “Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders.”
Manufacturers began implementing the new labeling in January, although packaging already in production or circulation was allowed to keep the old labeling.
The revised wording improves consistency and accuracy, according to FDA spokesperson Christine Parker. “[The decision] was based on feedback from several groups and individuals who expressed concern that [the causality sentence] was too broad a statement and might be misinterpreted, and thereby, misleading,” she told this newspaper.
Richard Gorman, M.D., chair of the American Academy of Pediatrics' committee on drugs, said he thinks the current labeling accurately reflects the data.
And he says the decision to drop the reference to causality has little implication for clinical care.
“Whether you say it's causal or that there's an increased risk of suicide—that's legal terminology. I don't think it makes much difference to the clinician. The message is pretty identical—which is that there is an increased risk of suicide when you use these medications,” he said in an interview.
Unlike Dr. Robb, Dr. Gorman does not believe that the black box warning will deter physicians from prescribing antidepressants when they are appropriate.
“I think they will be less likely to prescribe this medication for the borderline cases—but not for patients who meet the criteria for major depressive disorder. You would not give cancer chemotherapy to people who have colds. But you would have no hesitation giving it to people with cancer,” Dr. Gorman pointed out.