SAN DIEGO —More than 40% of pediatric clinicians say that the FDA’s black box warning accompanying all antidepressants has influenced the likelihood of their prescribing such medications for their pediatric patients. However, less than a third of those physicians who were so influenced by the warning actually believed that antidepressants were associated with a worsening of suicidality, according to Timothy J. Petersen, PhD, and colleagues.

The findings, based on a survey of pediatric psychopharmacologists and presented at the 160th Annual Meeting of the American Psychiatric Association, demonstrate the impact that the FDA’s directive in 2004 has had on the prescribing beliefs of community-based practitioners. The results also reveal seemingly contradictory views held by some clinicians on the matter.

“Survey data from this clinician sample suggest that the FDA black box warning concerning antidepressant use in pediatric patients has impacted global prescription,” stated Dr. Petersen, Assistant Professor of Psychiatry at Harvard Medical School in Boston. “However, more detailed survey questions reveal a somewhat confusing picture concerning beliefs about specific medications.”

THE FDA WEIGHS IN

In October 2004, the FDA issued a Public Health Advisory announcing a strategy to warn the public about the increased risk of suicidal thoughts and behavior in children and adolescents being treated with antidepressants. As part of that effort, the agency directed drug manufacturers to add a black box warning to the health professional labeling of all antidepressants to describe this risk and to emphasize the need for close monitoring of patients who begin to take these medications.

The warning, which appears on the package insert of the antidepressants, notes that “a greater risk of adverse events representing suicidal behavior or thinking (suicidality) during the first few months of treatment” was found in patients who used the drugs, compared with those who received a placebo. The FDA’s action sparked debate and concerns within the psychiatric community, as many clinicians feared that the warning would have a chilling effect on the prescribing of these medications to children and adolescents who most needed them. Many researchers are also divided on the association between antidepressants and potential risk of suicidality.

ANTIDEPRESSANTS, SAFETY, AND CHILDREN

A total of 318 pediatric psychopharmacologists, among 628 overall attendees of the 2005 annual review course on pediatric psychopharmacology conducted by the Massachusetts General Hospital Psychiatry Department, completed the survey. The mean age of participants was 53, and 57% of subjects were female. Among the sample, 77% were physicians and 23% were other licensed prescribers. In addition, respondents had been in practice for a mean of 20 years. Questions in the survey pertained to such issues as professional training background, practice characteristics, and beliefs about the association between antidepressants and suicidality.

Dr. Petersen and colleagues found that 42.2% of respondents believed that the black box warning had decreased their likelihood of prescribing antidepressants for children and adolescents. About 22% of clinicians indicated that specific medications were more closely associated with potential worsening of suicidality than others, with two-thirds naming SSRIs. However, 60% of respondents reported that certain medications were more associated with improvement in suicidality than others, with the vast majority, again, naming SSRIs, according to Dr. Petersen.

Although the majority (60%) of clinicians said that the warning had not affected the likelihood of their prescribing antidepressants, 17% of this group still believed that certain medications were associated with a worsening of suicidality.

“These results possibly suggest a distinction between likelihood of prescribing antidepressants to children and adolescents and an assignment of relative risk for each type of medication,” said Dr. Petersen.

Among other drugs believed to be most associated with an increased risk in suicidality, about 11% of survey respondents chose bupropion, 8% selected serotonin and noradrenaline reuptake inhibitors, and 5% chose tricyclic antidepressants.

“No statistically significant relationships were found between demographic and practice characteristics and survey responses,” Dr. Petersen pointed out. “These characteristics included age, gender, prescribing discipline, practice location, practice type, and time in practice.”

Dr. Petersen also noted a number of study limitations, including a sampling bias associated with a modest survey response rate, the status of survey responders as course participants, and the lack of data on actual prescriptions written. “Future research should explore in a more systematic manner provider characteristics that are associated with certain beliefs and behavior changes,” he said.  

—Colby Stong

Suggested Reading
Bridge JA, Salary CB, Birmaher B, et al. The risks and benefits of antidepressant treatment for youth depression. Ann Med. 2005;37(6):404-412.
Klein DF. The flawed basis for FDA post-marketing safety decisions: the example of antidepressants and children. Neuropsychopharmacology. 2006;31(4):689-699.Nemeroff CB, Kalali A, Keller MB, et al. Impact of publicity concerning pediatric suicidality data on physician practice patterns in the United States. Arch Gen Psychiatry. 2007;64(4):466-472.

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