The number of U.S. children being prescribed antidepressants appears to have dropped since warnings about suicidal behavior associated with the drugs, a new study found.
In October 2003, the U.S. Food and Drug Administration issued a public health advisory, warning of an increased risk of suicide attempts or suicide-related behavior among children and teens taking antidepressants known as selective serotonin reuptake inhibitors, which include Prozac. Then, in March 2004, the FDA issued another advisory, telling manufacturers to include a "black box warning" on product labels that recommends the monitoring of adults and children taking the drugs.
The drop-off in prescriptions of the drugs for children could be potentially worrisome, one expert said, because it may mean that young patients who could benefit from the medications aren't getting them.
"The publicity and media coverage surrounding the FDA hearings and advisories clearly contributed to the significant reduction in the use of selective serotonin reuptake inhibitors (SSRIs) antidepressants in the treatment of children and adolescents," said Dr. David Fassler, a clinical professor of psychiatry at the University of Vermont College of Medicine.
"The shift in practice patterns was most evident among pediatricians and other primary-care physicians," said Fassler, who was not involved in the study.
The results are published in the April issue of the Archives of General Psychiatry.
In the study, Dr. Charles B. Nemeroff, of Emory University School of Medicine, and colleagues looked at prescriptions written for SSRIs. The data included about 55 percent of all U.S. pharmacy claims, including private payers, Medicaid and cash purchases. In total, there were more than 1.4 billion prescriptions per year. The survey included about 3,400 physicians in 29 specialties. The researchers used this snapshot to project the number of diagnoses and prescriptions for antidepressants in the United States.
Nemeroff's team found that prescriptions of antidepressants for teens and children increased 0.79 percent per month from April 2002 to February 2004, then decreased by 4.23 percent per month from February 2004 to July 2004, and was stable from July 2004 to March 2005.
Moreover, there was a shift in who was providing care to depressed children and teens -- away from primary-care physicians to psychiatrists, the researchers found.
From the period December 2003 through February 2004, psychiatrists took care of 44 percent of children and teens with depression. But, that number grew to 63 percent for the period December 2004 through February 2005.
The only SSRI approved by the FDA for use in pediatric patients is fluoxetine (Prozac). However, the analyses also showed a trend toward prescribing bupropion, a non-SSRI antidepressant, to young patients, the study authors said.
This "could stem in large part from physicians attributing the increased risk of suicidality primarily to SSRIs, even though bupropion is also labeled with a black box warning," the researchers noted.
"It is evident, however, that there is need for additional exploration into the relationship between FDA action, media reaction and physician behavior change to ensure that dissemination of drug safety information does not interfere with appropriate access to care," Nemeroff's group concluded.
Fassler said this finding is "of particular concern when viewed in the context of the recent report from the U.S. Centers for Disease Control and Prevention documenting the unexpected and disconcerting increase in the adolescent suicide rate between 2003 and 2004."
Based on the data currently available, he said, it would be premature to conclude there's a definitive causal link between the rate of suicides and the lower rate of prescriptions for SSRIs, Fassler said. "However, we do know that it's become increasingly difficult for many young people to access effective and appropriate treatment for depression," he said.
But another expert disagrees that use of all SSRIs has declined among children and teens.
"Information I have says that the use of Prozac has increased over time," said Dr. Randall S. Stafford, director of the Program on Prevention Outcomes and Practices at the Stanford University School of Medicine's Prevention Research Center.
Strafford stressed that treating depression in children and teens should include a combination of drugs and counseling. "Physicians were prescribing more drugs without following the advice that pediatric patients should also receive counseling and frequent follow-up," he said.
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