Fewer Children and Teens Received Antidepressants Following FDA Warnings
CHICAGO, April 2, 2007—The number of children and teenagers prescribed antidepressant medications appears to have decreased following public warnings about suicidal behavior potentially associated with the drugs, according to a report published in the April issue of Archives of General Psychiatry, one of the JAMA/Archives journals. In addition, antidepressants are now more often prescribed to this age group by psychiatrists rather than primary care physicians.
The U.S. Food and Drug Administration (FDA) issued a public health advisory on Oct. 27, 2003, warning of an increased risk of suicidality (suicide attempts or suicide-related behavior) among children and teens taking antidepressants, according to background information in the article. A much-publicized hearing was held on the topic in February 2004. On March 22, 2004, the FDA issued another advisory instructing manufacturers to include a black-box warning on product labels recommending close monitoring of adults and children taking antidepressants. Conflicting information has since been presented regarding whether these warnings had any effects on prescription patterns.
Charles B. Nemeroff, M.D., Ph.D., Emory University School of Medicine, Atlanta, and colleagues analyzed prescription data and information from physician surveys provided by Verispan, a Pennsylvania-based health care information company. The prescription data capture about 55 percent of all U.S. retail pharmacy claims, including private payers, Medicaid and cash transactions—more than 1.4 billion prescriptions per year. The physician survey involved approximately 3,400 office-based physicians across 29 specialties, and is projected out to provide a representative view of diagnoses and prescriptions in the United States.
Upon analyzing the data from 2000 to 2005, the researchers found that “the growth in total antidepressant prescriptions seemed to begin to slow around the timing of the public health advisories in October 2003 and March 2004 about pediatric suicidality,” they write. “However, by the time the FDA panel met to discuss the data findings in September 2004, the proceedings from the meeting had little effect on the market—behavior had already been altered.” Prescriptions of antidepressants to patients younger than 18 years increased by .79 percent per month from April 2002 to February 2004, decreased by 4.23 percent per month from February 2004 to July 2004 and stabilized from July 2004 to March 2005.
In addition, “there has been a shift in the providers of care of depressed patients younger than 18 years away from primary care and other providers to psychiatrists,” the authors write. From December 2003 through February 2004, psychiatrists accounted for 44 percent of patient care for those younger than 18 years. From December 2004 through February 2005, psychiatrists cared for 63 percent of pediatric and adolescent depressed patients.
The only antidepressant approved by the FDA for use in pediatric patients is fluoxetine, which is a member of a class known as selective serotonin reuptake inhibitors (SSRIs). However, the analyses also showed a trend toward prescribing bupropion, a non-SSRI antidepressant, to young patients. This trend “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.”
Although the findings do not speak to whether these changes in
prescriptions are appropriate, they do indicate that the warnings
have had an effect, the authors write. It is also unclear how
warnings about suicidality and antidepressants in older patients
will change the treatment of depression. “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,” the authors conclude.
(Arch Gen Psychiatry. 2007;64:466-472. Available to the media pre-embargo at www.jamamedia.org).
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Posted: April 2007