AMA Opposes Restrictions On SSRI Use In Youngsters
Selective serotonin reuptake inhibitors (SSRIs) should remain available for use in children and adolescents, including for unlabeled uses, according to a report adopted by the AMA House of Delegates at the organization's annual policy-making meeting in Chicago last month.
The report was written by the AMA's Council on Scientific Affairs (CSA) in response to a resolution brought to the house at last year's meeting by APA and the American Academy of Child and Adolescent Psychiatry (AACAP).
The report also states that current clinical evidence indicates that fluoxetine is an effective SSRI in children and adolescents with major depressive disorder, and it calls for a review of how FDA regulatory actions impact prescribing patterns, patient compliance, and access to medications.
“A causal role for antidepressants in increasing suicides in children and adolescents has not been established,” the CSA report states.
The council's report was adopted without debate on the floor of the house and had widespread support from pediatricians and other physicians during reference committee hearings. Along with several other actions that originated with the APA Section Council on Psychiatry and were approved virtually without opposition (see story on Original article: page 8), the council's report on SSRIs is evidence of the growing influence of psychiatry within the house of medicine, APA leaders say.
“This is an excellent example of the importance of psychiatry's involvement in the house of medicine,” said John McIntyre, M.D., chair of the Section Council on Psychiatry and head of APA's delegation. “This issue was identified by APA and AACAP last year, and as the report was being prepared, there was dialogue between the AMA and APA around the content of the report.
“This is a major issue for our patients,” he added. “We are now at a level of participation that when issues come up that involve our patients, we can be confident that we will be part of the solution.”
David Fassler, M.D., vice chair of the Section Council on Psychiatry and AACAP's delegate, was the author of the original resolution calling for the report. He said during reference committee hearings that the report would likely do much to dispel public and professional confusion that has surrounded the FDA's action regarding antidepressants and children.
“The conclusions and recommendations... confirm that medication can be an effective and important component of treatment for children and adolescents with depression,” Fassler said. “The report also acknowledges the importance of continued access to the full range of these medications, and it calls for ongoing research with an emphasis on larger studies and long-term follow-up, which will ultimately give us more clinically relevant data regarding both the safety and efficacy of these medications.”
(Reference committee hearings are held prior to the convening of the House of Delegates and offer an opportunity for any AMA member and invited public representatives to voice opinions on all reports and resolutions brought to the House. On the basis of testimony heard at the reference committee, a recommendation is made to the full house to adopt, amend, or not adopt those reports and resolutions; a decision is also sometimes made to refer an item for deliberation to the AMA Board of Trustees or to an appropriate council.)
Melvyn Sterling, M.D., an internist and chair of the CSA, urged adoption of the report during reference committee hearings, saying the issue was one of the most important facing physicians who treat children and adolescents.
“As director of an emergency department of a university medical center, I have treated thousands” of people who have made suicide attempts, Sterling said. “I view this as one of the most important conditions that we as physicians and a society have to deal with. We have to deal with suicidality and with the awesome social and economic impact of depression on our society. For us to deny patients access to what could be the most important medication in their lives, when the data [about suicide] are actually equivocal, I think would be very, very sad.”
The CSA report summarizes recent regulatory actions related to the labeling of antidepressants and their use in children and adolescents; evaluates the apparent safety and efficacy of antidepressants, particularly the SSRIs in children and adolescents; and reviews the evidence on whether these drugs may have a causal role in the emergence of suicidality or other harmful behavior during treatment.
The report concludes with four recommendations:
That SSRIs should remain available for use in children and adolescents, including unlabeled uses, subject to the exercise of prudent clinical judgment and development of clinical guidelines for treatment. Current clinical evidence indicates that fluoxetine is an effective SSRI in children and adolescents with major depressive disorder, the report states. | |||||
That the AMA urge the Food and Drug Administration (FDA) to ensure that studies conducted by sponsors in pursuit of pediatric exclusivity be adequately designed and of sufficient duration to answer clinically relevant efficacy and/or safety questions that have evolved in a particular therapeutic area. | |||||
That the AMA recognize that the current product labeling (package insert) of antidepressant drugs, including the black-box warnings, is a precautionary statement intended to reinforce the need for careful monitoring of patients with depression and other psychiatric disorders during the initiation of treatment. This product labeling should not be interpreted in a way that would decrease access for patients who may benefit from these drugs, the report states. | |||||
That the FDA evaluate the impact of labeling changes it mandates for antidepressants, including the black-box warnings and patient medication guide on treatment patterns, patient compliance, and patient access. | |||||
In related action, the House of Delegates adopted, without debate, a second resolution put forward by APA and AACAP that asks the AMA to endorse efforts to train additional qualified clinical investigators in pediatrics, child psychiatry, and therapeutics to conduct studies related to the effects of psychotropic drugs in children, adolescents, and young adults.
That resolution also asks the AMA to promote efforts to educate physicians about the appropriate use of psychotropic medications for children, adolescents, and young adults.
More information about these and other actions taken at the AMA's 2005 annual meeting are posted online at<www.ama-assn.org/ama/pub/category/14887.html>.▪
