AACAP Members Testify Against ADHD Black Box

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FYI from Dr. Feder:~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~* AACAP Members Testify Against ADHD Black BoxDear AACAP member:Yesterday, the FDA Pediatric Advisory Committeeagreed to recommend that the FDA attach a MedicationGuide to each dosingcontainer for ADHD medications. The Committeemembers stopped short of requesting a black boxwarning be inserted into the label.The Committee met to discuss whether new safetywarnings should be added to the labeling of ADHDmedications, including Mixed Salts of Amphetamine(Adderall, Adderall XR), all methylphenidatemedications, and atomoxetine (Strattera). TheCommittee discussed severe and rare psychiatric andcardiovascular adverse events that had been reportedin patients taking ADHD medications. As you mayrecall, in February the FDA Drug Safety and RiskManagement (DsRM) Committee, comprised ofcardiologists and epidemiologists, recommended thatthe FDA add Medication Guides and black box warningsto ADHD medications because of concerns aboutcardiovascular adverse events. Clickhere to read previous member email(http://rs6.net/tn.jsp?t=bqd47tbab.0.7u747tbab.wz8k9abab.1472 & p=http%3A%2F%2Fwww.aacap.org%2FAnnouncements%2Fpdfs%2FAACAP_Statement_FDA_Advisory_Methylphenidate.pdf).The Pediatric Advisory Committee, comprised ofpediatricians and child and adolescentpsychiatrists, heard a series of presentations frompediatricians, child and adolescent psychiatrists,and FDA officers concerning the reports ofneuropsychiatric (hallucinations, aggression, andsuicidal ideation and behavior) and cardiovascular(sudden unexpected death, acute myocardialinfarctions) adverse events experienced by childrenand adolescents. These data had been obtained fromcontrolled studies, from post-marketing informationsupplied to the pharmaceutical companies by theirdrug representatives, and from the FDA Adverse EventReporting System, MEDWATCH.In addition, the Committee heard from 40 publicwitnesses. AACAP would like to thank the AACAPmembers who provided statements. LarryGreenhill, M.D. and Adelaide Robb,M.D. have been vigilant in advocating forthe best treatment for children and adolescents, andpresented testimony for theAACAP. Other AACAP members who presented testimonyincluded: Glen Elliott, M.D., Fassler, M.D., Tom Kobylski, M.D., Judy Rapoport,M.D., Read Sulik, M.D., and Carol Watkins,M.D.Dr. Greenhill asked the Committee to develop methodsto assist physicians in assessing the possibility ofrare adverse events when selecting ADHD treatements;and to address the issueof whether new practice procedures (routine pulseand blood pressure readings, EKGs, orechocardiograms) are necessary to deal with safetyconcerns. He urged the panel to recommend that theFDA set new standards for adverse event collectionand coding, and to conduct additional post-marketingstudies on adverse events before placing a strongerwarning on these medications. He also outlined theproblems with the FDA’s post-marketing surveillancesystem, the Adverse Event Reporting System orMedWatch, which makes it difficult to determine therate of adverse events associated with a specificmedication. He further “urged both thepharmaceutical industry and the FDA to agree on astandard method for collecting safety information.â€Dr. Robb discussed results from a NationalInstitute on Neurological Disorders and Strokecontrolled, double-blind study that reported lowerblood pressure readings when children with ADHD weretreated with methylphenidate, clonidine, or thecombination, than when they were given placebo.After reviewing all the information provided, thePediatric Advisory Committee recommended aMedication Guide and not a black box warning. TheCommittee members did not think the data providedenough evidence to issue the strongest label, ablack box warning.The Committee members also discussed several otherrecommendations including: the need for increasedcommunication between physicians and parents;inclusion of quantifiable data on the rarity of theevents in the warning labels; and the need forlongitudinal studies on the effects of ADHDmedications.The AACAP, under Dr. Greenhill’s leadership, willcontinue to work with the FDA using our practiceparameters and other information to assist in makingthe most informed decisions. We will also develop aset of talking points for you to share with parentsand patients.For additional information on treating children andadolescents with ADHD, please refer to the AACAPwebsite.Facts for Families #6 “ChildrenWho Can’t Pay Attention(http://rs6.net/tn.jsp?t=bqd47tbab.0.hzwt8tbab.wz8k9abab.1472 & p=http%3A%2F%2Fwww.aacap.org%2Fpublications%2Ffactsfam%2Fnoattent.htm)â€PracticeParameter on Assessing and Treating ADHD(http://rs6.net/tn.jsp?t=bqd47tbab.0.jzwt8tbab.wz8k9abab.1472 & p=http%3A%2F%2Fwww.aacap.org%2Fclinical%2Fparameters%2Ffulltext%2FAdhd.pdf)PracticeParameter on Stimulant Medications(http://rs6.net/tn.jsp?t=bqd47tbab.0.6u747tbab.wz8k9abab.1472 & p=http%3A%2F%2Fwww.aacap.org%2Fclinical%2Fparameters%2Ffulltext%2FStimMed.pdf)Dr.Larry Greenhill’s Testimony before the FDA PediatricAdvisory Committee – March 22, 2006(http://rs6.net/tn.jsp?t=bqd47tbab.0.5u747tbab.wz8k9abab.1472 & p=http%3A%2F%2Fwww.aacap.org%2FAnnouncements%2FPDFs%2FGreenhill_Testimony_0306.pdf)AACAPPolicy Statement on Prescribing PsychoactiveMedications for Children and Adolescents(http://rs6.net/tn.jsp?t=bqd47tbab.0.izwt8tbab.wz8k9abab.1472 & p=http%3A%2F%2Fwww.aacap.org%2Fpublications%2Fpolicy%2Fps41.htm)Tom Anders, M.D.AACAP President~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~American Academy of Child and Adolescent Psychiatry | 3615 WisconsinAvenue, N.W. | Washington | DC | 20016-3007

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