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March 2006: Pediatric Advisory Committee and ADHD Products. Dr. Dianne Murphy Director, Office of Pediatric Therapeutics Office of the Commissioner. Risk. No drug therapy is without risk An untreated condition carries risk. Successful Treatment. A proper diagnosis
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March 2006: Pediatric Advisory Committee and ADHD Products Dr. Dianne Murphy Director, Office of Pediatric Therapeutics Office of the Commissioner
Risk • No drug therapy is without risk • An untreated condition carries risk
Successful Treatment • A proper diagnosis • An effective therapy for the population being treated • Selection of appropriate dose • Knowledge about the adverse events • An appropriate communication about risk: such as-level of certainty, actions
The FDA has identified two possible safety concerns with the methylphenidate drug products: psychiatric adverse events and cardiovascular adverse events. Statement on Concerta and Methylphenidate for the June 30, 2005Pediatric Advisory Committee
Psychiatric Adverse Events (cont’d) • We intend to make labeling changes describing these events. In addition, we believe it is critical to examine the other stimulant drug products approved for ADHD, specifically the amphetamine products, and atomoxetine (not a stimulant), to determine if they too are associated with these adverse events. • We are currently examining the post-marketing reports for these products. We will bring to this committee a review of the amphetamine adverse events and, we hope, events associated with atomoxetine, in early 2006.
Cardiovascular Adverse Events • The agency believes that it is not yet possible to determine whether these events, especially the more serious ones, are causally associated with these treatments. The FDA is pursuing additional means to better characterize the cardiovascular risks for all drug products approved for ADHD. Potential options under consideration include population-based pharmaco-epidemiologic studies, long term safety trials and other targeted CV risk studies. • It is our proposal that the FDA obtain these additional data to help guide the development of any regulatory action regarding potential CV risks of drug products approved for ADHD.
Background Package Information from June 2005 In addition to all of the reviews for today’s meeting, you have in your background package a table which summarizes all of the psychiatric and neurological events for methylphenidate products. This table was compiled from the data presented in June.
Today’s Update on Pediatric Safety Information • Review of AERS events for Adderall XR during the 1-yr post exclusivity • Review of AERS psychiatric events for most products used to treat ADHD including additional reports requested from sponsor • Review of sponsors’ submission of psychiatric AE’s from 100 ADHD clinical trials, in response to a specific FDA request • Review of cardiac AE’s from AERS for ADHD products • Possible future studies to assess cardiac risk.
PANEL’S TASK • Assess the potential psychiatric and cardiovascular risks with use of products to treat ADHD in the pediatric population • Advise FDA on how best to communicate risk so physicians and parents can make informed decisions • Advise FDA on how best to address risk for all of the therapies used to treat ADHD to avoid inappropriate switching to products for which we have less safety information
Questions for the Committee Because these products have been shown to be effective when used to treat children who have been properly diagnosed as having ADHD, there will continue to be a need for access to these therapies. You have received information on potential cardiovascular and neuropsychiatric risks associated with the use of medications to treat ADHD in children. This information included adverse events from spontaneous reports and clinical trial data, the current labeling and FDA’s plans for additional studies on cardiovascular risk. In consideration of this information, please address the following questions concerning psychiatric and cardiovascular adverse events.
Questions for the Committee Psychiatric Adverse Events potentially associated with drugs to treat ADHD in children: • What are the important messages you think should be conveyed to physicians and parents regarding these potential risks? In your discussion, please comment on the strength of the evidence relevant to the identified risks. As appropriate, identify differences among drug products. • Are the messages about these potential risks being adequately communicated through current labeling? • If not, what additional information or changes should be made to the label? • What other mechanisms should be employed to communicate these potential risks to practitioners, families and patients?
Questions for the Committee CardiovascularAdverse Events potentially associated with drugs to treat ADHD in children: • What are the important messages you think should be conveyed to physicians and parents regarding these potential risks? In your discussion, please comment on the strength of the evidence relevant to the identified risks. As appropriate, identify differences among drug products. • Are the messages about these potential risks being adequately communicated through current labeling? • If not, what additional information or changes should be made to the label? • What other mechanisms should be employed to communicate these potential risks to practitioners, families and patients?
