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© 2004 American Academy of Pediatrics

NEWS AND FEATURES

AAP calls on FDA to modify antidepressant monitoring program

by Taryn Rosenkranz
Washington Correspondent

While the Academy supports the recent Food and Drug Administration (FDA) decision to provide "black box" warnings on all antidepressant medications, it will ask the FDA to reconsider and modify several points to protect patient safety and reduce potential liability concerns.

On Oct. 15, the FDA ordered pharmaceutical companies to add a black box warning on all antidepressants to alert health care providers of an increased risk of suicidal thoughts or ideation in pediatric patients. Since the decision, the Academy has been working to provide advice to its members who prescribe antidepressants.

While the FDA did not contraindicate the medications, inclusion of a black box warning is the toughest requirement federal drug regulators can impose, short of banning a medication. The Academy is concerned about several aspects of the FDA's recommended clinical monitoring program for all patients who are on these medications.

Recent estimates suggest at least one in 10 children suffers from mental illness severe enough to cause some level of impairment. Pediatricians prescribe approximately 15% of antidepressants used by children and adolescents.

The follow-up monitoring program outlined by the FDA may be too restrictive and could diminish the number of primary care pediatricians willing to continue prescribing antidepressants. The Academy's main concern is ensuring access to the best therapies for children who suffer from mental health disorders, and it appears this program may hinder access.

FDA exact language on monitoring: "All pediatric patients being treated with antidepressants for any indication should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Ideally, such observation would include at least weekly face-to-face contact with patients or their family members or caregivers during the first 4 weeks, then at biweekly visits for the next 4 weeks, then at 12 weeks, and as clinically indicated beyond 12 weeks. Additional contact by telephone may be appropriate between face-to-face visits."

The Academy will draft a letter asking the FDA to address the following concerns regarding the recommended monitoring program:

• The monitoring program is based on a clinical trial monitoring program and not an office practice. It will be necessary for medical and health professionals to develop monitoring guidelines appropriate for practice and clinic settings. Furthermore, it excludes the possibility of follow-up by mental health providers who are not physicians as well as telephone visits, which can be as beneficial as face-to-face visits with physicians.
• The use of the word "ideally" in the FDA's proposed monitoring language may be interpreted as the gold standard of monitoring programs, suggesting that other monitoring guidelines may be less effective, thereby opening physicians up to potential litigation.
• The inclusion of "other psychiatric disorders" in the FDA's warning label would require the same amount of monitoring for those patients as patients with major depressive disorder. There is little evidence to show that other psychiatric disorders (e.g., obsessive compulsive disorder or social anxiety) need equivalent monitoring.
• The Academy's primary concern is ensuring access to care for children who need these treatments for depression and other psychiatric disorders. Poor reimbursement levels coupled with an onerous clinical follow-up regime may make mental health services virtually unavailable for large numbers of children.

The Academy is taking several additional steps to help its members best address the new warning. AAP leadership will form a work group with the American Psychiatric Association, the American Academy of Child and Adolescent Psychiatry and the American Academy of Family Physicians to develop an antidepressant advisory that will help physicians diagnose, treat and monitor their depressed patients.

The Academy also is working to help pediatricians deal with adolescent depression through many of its committees and sections, including the newly formed AAP Task Force on Mental Health.

For advice on treating children with antidepressants, visit www.aapnews.org/cgi/content/full/e2004146v1. For further clinical information, look to future issues of AAP News, visit the AAP Member Center, www.aap.org/moc, or contact Mary Crane, AAP Department of Committees and Sections, at (800) 433-9016, ext. 4273, or e-mail mcrane{at}aap.org.

Richard L. Gorman, M.D., FAAP, Gary N. McAbee, D.O., J.D., FAAP, Laurel K. Leslie, M.D., FAAP, and Lynn Wegner, M.D., FAAP, contributed to this report.

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