{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T03:25:05Z","timestamp":1793330705114,"version":"4.5.0"},"reference-count":17,"publisher":"American Academy of Pediatrics (AAP)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2015,12,1]]},"abstract":"\n BACKGROUND AND OBJECTIVES:<\/jats:title>\n In 2002, Congress mandated that the US Food and Drug Administration (FDA) monitor postmarketing pediatric adverse events and present safety reports to the FDA\u2019s Pediatric Advisory Committee (PAC). These safety reviews play a critical role in the postmarketing surveillance and identification of pediatric safety issues. This article follows a previous review ending in 2007 and summarizes 6 years of recent pediatric safety reporting, recommendations by the PAC, and actions by the FDA, including labeling changes.<\/jats:p>\n <\/jats:sec>\n \n METHODS:<\/jats:title>\n An analysis of the FDA\u2019s PAC safety reviews performed from November 2007 through September 2013 was conducted. PAC recommendations for subsequent labeling changes, future studies, or other safety issues were reviewed.<\/jats:p>\n <\/jats:sec>\n \n RESULTS:<\/jats:title>\n There were 6930 serious adverse event reports in 181 reviews. These findings resulted in 33 (18%) recommended labeling changes, and 21 (64%) of these changes were adopted. For 10 products, information was added to the Warning and Precautions section of the label. The PAC also discussed or recommended additional studies for certain products.<\/jats:p>\n <\/jats:sec>\n \n CONCLUSIONS:<\/jats:title>\n This article highlights the importance of the FDA\u2019s ongoing pediatric postmarketing safety reviews of regulated products, advice from the PAC, and FDA actions in the best interest of pediatric patients. This mandated process facilitates detection of safety concerns that may not be identified in prelicensure clinical trials. It continues to identify critical safety concerns, including unlabeled adverse events, frequent off-label use, product misuse, and secondary exposures in children.<\/jats:p>\n <\/jats:sec>","DOI":"10.1542\/peds.2015-0469","type":"journal-article","created":{"date-parts":[[2015,11,24]],"date-time":"2015-11-24T01:47:46Z","timestamp":1448329666000},"page":"1125-1131","source":"Crossref","is-referenced-by-count":19,"title":["FDA Safety Reviews on Drugs, Biologics, and Vaccines: 2007\u20132013"],"prefix":"10.1542","volume":"136","author":[{"given":"Judith U.","family":"Cope","sequence":"first","affiliation":[{"name":"Office of Pediatric Therapeutics, Office of Special Medical Programs, Office of the Commissioner, Food and Drug Administration, Silver Spring, Maryland; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geoffrey L.","family":"Rosenthal","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela","family":"Weinel","sequence":"additional","affiliation":[{"name":"Office of Pediatric Therapeutics, Office of Special Medical Programs, Office of the Commissioner, Food and Drug Administration, Silver Spring, Maryland; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy","family":"Odegaard","sequence":"additional","affiliation":[{"name":"Office of Pediatric Therapeutics, Office of Special Medical Programs, Office of the Commissioner, Food and Drug Administration, Silver Spring, Maryland; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dianne M.","family":"Murphy","sequence":"additional","affiliation":[{"name":"Office of Pediatric Therapeutics, Office of Special Medical Programs, Office of the Commissioner, Food and Drug Administration, Silver Spring, Maryland; and"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"417","published-online":{"date-parts":[[2015,12,1]]},"reference":[{"key":"2021120906155356200_B1","first-page":"107","volume":"1408","author":"Best Pharmaceuticals for Children Act","year":"2002","journal-title":"Stat"},{"key":"2021120906155356200_B2","unstructured":"Pediatric Research Equity Act. Vol 117 Stat 1936;2003:108\u2013155. Available at: www.gpo.gov\/fdsys\/pkg\/STATUTE-117\/pdf\/STATUTE-117-Pg1936.pdf. Accessed October 5, 2015"},{"key":"2021120906155356200_B3","unstructured":"Food and Drug Administration. Food and Drug Administration Amendments Act (FDAAA) of 2007. Available at: http:\/\/www.gpo.gov\/fdsys\/pkg\/PLAW-110publ85\/html\/PLAW-110publ85.htm. Accessed October 5, 2015"},{"key":"2021120906155356200_B4","unstructured":"The Food and Drug Administration Safety and Innovation Act (FDASIA). Available at: www.gpo.gov\/fdsys\/pkg\/PLAW-112publ144\/pdf\/PLAW-112publ144.pdf. Accessed October 5, 2015"},{"issue":"3","key":"2021120906155356200_B5","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2008-0585","article-title":"Safety monitoring of drugs receiving pediatric marketing exclusivity.","volume":"122","author":"Smith","year":"2008","journal-title":"Pediatrics"},{"key":"2021120906155356200_B6","unstructured":"US Department of Health and Human Services, US Food and Drug Administration. MedWatch and guidance on AE reporting. Available at: www.fda.gov\/Safety\/MedWatch\/HowToReport\/ucm053087.htm. Accessed October 5, 2015"},{"key":"2021120906155356200_B7","unstructured":"US Department of Health and Human Services. Vaccine Adverse Event Reporting System (VAERS). Available at: http:\/\/vaers.hhs.gov\/index. Accessed October 5, 2015"},{"key":"2021120906155356200_B8","unstructured":"US Department of Health and Human Services, US Food and Drug Administration. CFR\u2014Code of Federal Regulations Title 21. Available at: www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfCFR\/CFRSearch.cfm. Accessed October 5, 2015"},{"key":"2021120906155356200_B9","unstructured":"US Department of Health and Human Services, US Food and Drug Administration. Pediatrics. Available at: www.fda.gov\/ScienceResearch\/SpecialTopics\/PediatricTherapeuticsResearch\/default.htm. Accessed October 5, 2015"},{"issue":"1","key":"2021120906155356200_B10","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1002\/pds.1679","article-title":"Pediatric drug surveillance and the Food and Drug Administration\u2019s adverse event reporting system: an overview of reports, 2003-2007.","volume":"18","author":"Johann-Liang","year":"2009","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"2021120906155356200_B11"},{"key":"2021120906155356200_B12","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1146\/annurev-med-060309-164311","article-title":"Role of postmarketing surveillance in contemporary medicine.","volume":"62","author":"Woodcock","year":"2011","journal-title":"Annu Rev Med"},{"issue":"4","key":"2021120906155356200_B13","doi-asserted-by":"crossref","first-page":"481","DOI":"10.1111\/j.1365-2125.2010.03682.x","article-title":"Information about adverse drug reactions reported in children: a qualitative review of empirical studies.","volume":"70","author":"Aagaard","year":"2010","journal-title":"Br J Clin Pharmacol"},{"issue":"5","key":"2021120906155356200_B14","doi-asserted-by":"crossref","first-page":"787","DOI":"10.1038\/clpt.2012.24","article-title":"Monitoring the safety of medicines used off-label.","volume":"91","author":"Dal Pan","year":"2012","journal-title":"Clin Pharmacol Ther"},{"issue":"5","key":"2021120906155356200_B15","doi-asserted-by":"crossref","first-page":"w770","DOI":"10.1377\/hlthaff.28.5.w770","article-title":"Broadened use of atypical antipsychotics: safety, effectiveness, and policy challenges.","volume":"28","author":"Crystal","year":"2009","journal-title":"Health Aff (Millwood)"},{"key":"2021120906155356200_B16","unstructured":"US Food and Drug Administration. Boxwell D. Informational update: Kaletra oral solution toxicity in neonates\u2014lopinavir, ethanol and\/or propylene glycol? Available at: www.fda.gov\/downloads\/AdvisoryCommittees\/CommitteesMeetingMaterials\/PediatricAdvisoryCommittee\/UCM272865.pdf. Accessed October 5, 2015"},{"issue":"2","key":"2021120906155356200_B17","doi-asserted-by":"crossref","first-page":"81","DOI":"10.1016\/j.acap.2008.11.010","article-title":"Off-label prescribing to children in the United States outpatient setting.","volume":"9","author":"Bazzano","year":"2009","journal-title":"Acad Pediatr"}],"container-title":["Pediatrics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/publications.aap.org\/pediatrics\/article-pdf\/136\/6\/1125\/1062546\/peds_2015-0469.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/publications.aap.org\/pediatrics\/article-pdf\/136\/6\/1125\/1062546\/peds_2015-0469.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,12,10]],"date-time":"2021-12-10T00:36:57Z","timestamp":1639096617000},"score":1,"resource":{"primary":{"URL":"https:\/\/publications.aap.org\/pediatrics\/article\/136\/6\/1125\/33901\/FDA-Safety-Reviews-on-Drugs-Biologics-and-Vaccines"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,12,1]]},"references-count":17,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2015,12,1]]},"published-print":{"date-parts":[[2015,12,1]]}},"URL":"https:\/\/doi.org\/10.1542\/peds.2015-0469","relation":{},"ISSN":["0031-4005","1098-4275"],"issn-type":[{"value":"0031-4005","type":"print"},{"value":"1098-4275","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,12,1]]}}}