{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T12:43:42Z","timestamp":1791031422015,"version":"4.1.0"},"reference-count":19,"publisher":"American Academy of Pediatrics (AAP)","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2002,11,1]]},"abstract":"<jats:p>Objective. To characterize risks to infants and young children from drugs and biological products that were identified in spontaneous adverse event reports submitted to the US Food and Drug Administration.<\/jats:p><jats:p>Methods. Of &amp;gt;500 000 MedWatch adverse event reports received by the Food and Drug Administration from November 1997 through December 2000, we identified 7111 reports about infants and children younger than age 2. The reports were analyzed for health outcome (eg, death, hospitalization, congenital anomaly), principal suspect drug, and whether the route of drug exposure was direct administration or through the mother in the perinatal period.<\/jats:p><jats:p>Results. Drug therapy was associated with an average of 243 reported deaths annually over the 38-month study period, with 100 (41%) occurring during the first month of life and 204 (84%) during the first year. In 1432 (24%) reported adverse event cases of all levels of severity, exposure to the drug was from the mother during pregnancy, delivery, or lactation. Although 1902 different drugs, biological products, and other chemicals were identified in the reports, only 17 drugs or biological products were a suspect in 54% of all serious and fatal adverse events in drugs administered directly.<\/jats:p><jats:p>Conclusion. Adverse reactions to drug therapy are a significant cause of death and injury in infants and children under 2 years of age. Drugs administered to the mother in the perinatal period constituted a major route of exposure to adverse drug advents. These results underscore the need for additional drug testing in the youngest pediatric patients and for carefully weighing the risks versus benefits of medication.<\/jats:p>","DOI":"10.1542\/peds.110.5.e53","type":"journal-article","created":{"date-parts":[[2004,8,14]],"date-time":"2004-08-14T00:17:55Z","timestamp":1092442675000},"page":"e53-e53","source":"Crossref","is-referenced-by-count":94,"title":["Reported Adverse Drug Events in Infants and Children Under 2 Years of Age"],"prefix":"10.1542","volume":"110","author":[{"given":"Thomas J.","family":"Moore","sequence":"first","affiliation":[{"name":"Center for Health Services Research and Policy, George Washington University School of Public Health and Health Services, Washington, DC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheila R.","family":"Weiss","sequence":"additional","affiliation":[{"name":"School of Medicine, University of Maryland, Baltimore, Maryland"},{"name":"School of Pharmacy, University of Maryland, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sigal","family":"Kaplan","sequence":"additional","affiliation":[{"name":"School of Pharmacy, University of Maryland, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carol J.","family":"Blaisdell","sequence":"additional","affiliation":[{"name":"Division of Pediatric Pulmonology and Allergy, University of Maryland School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"417","published-online":{"date-parts":[[2002,11,1]]},"reference":[{"key":"2021121006393263600_R1","unstructured":"Food and Drug Administration. The Pediatric Exclusivity Provision: January 2001 Status Report to Congress. Rockville, MD: Food and Drug Administration; 2001"},{"key":"2021121006393263600_R2","doi-asserted-by":"crossref","unstructured":"Kaushal R, Bates DW, Landrigan C. Medication errors and adverse drug events in pediatric inpatients. JAMA.2001;285:2114\u20132120","DOI":"10.1001\/jama.285.16.2114"},{"key":"2021121006393263600_R3","doi-asserted-by":"crossref","unstructured":"Kennedy DL, Goldman SA, Lillie RB. Spontaneous reporting in the United States. In: Strom BL, ed. Pharmacoepidemiology. New York, NY: John Wiley & Sons; 2000:151\u2013174","DOI":"10.1002\/0470842555.ch10"},{"key":"2021121006393263600_R4","unstructured":"Food and Drug Administration. Center for Drug Evolution and Research 2000 Report to the Nation: Improving Public Health Through Human Drugs. Rockville, MD: Food and Drug Administration; 2001"},{"key":"2021121006393263600_R5","unstructured":"Food and Drug Administration. Quarterly Extract from Adverse Event Reporting System. Springfield, VA: US Department of Commerce, National Technical Information Service; 2001"},{"key":"2021121006393263600_R6","unstructured":"MedDRA Maintenance and Support Services Organization. MedDRA Introductory Guide. Reston, VA: MedDRA Maintenance and Support Services Organization (MSSO); 2000"},{"key":"2021121006393263600_R7","unstructured":"Hoyert DL, Arias E, Smith BL, Murphy SL, Kochanek KD. Deaths: final data for 1999. Natl Vital Stat Rep.2001;49:1\u2013113"},{"key":"2021121006393263600_R8","unstructured":"Palivizumab (Synagis) for prevention of RSV infection. Med Lett Drugs Ther.1999;41:3\u20134"},{"key":"2021121006393263600_R9","unstructured":"INO Therapeutics Inc. INOmax (nitric oxide) for inhalation. Clinton, NJ: INO Therapeutics Inc; 1999:12\u201323"},{"key":"2021121006393263600_R10","doi-asserted-by":"crossref","unstructured":"Knight DB. The treatment of patent ductus arteriosus in preterm infants. A review and overview of randomized trials. Semin Neonatol.2001;6:63\u201373","DOI":"10.1053\/siny.2000.0036"},{"key":"2021121006393263600_R11","doi-asserted-by":"crossref","unstructured":"Shulman RJ, Boyle JT, Colletti RB, et al. The use of cisapride in children. J Pediatr Gastreoenterol Nutr.2002;28:529\u2013533","DOI":"10.1097\/00005176-199905000-00018"},{"key":"2021121006393263600_R12","unstructured":"Janssen Pharmaceutica Stops Marketing Cisapride in the US [press release]. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration; 2000"},{"key":"2021121006393263600_R13","unstructured":"Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med.1994;331:1173\u20131180"},{"key":"2021121006393263600_R14","unstructured":"Moore TJ, Weiss SR, Blaisdell CR. Reported fatal and serious adverse reactions associated with palivizumab [abstract]. Pediatr Acad Soc. 2002. Available at: http:\/\/www.pas-meeting.org\/2002baltimore\/latebreaker_files\/lbabstracts.htm#7062. Accessed September 17, 2002"},{"key":"2021121006393263600_R15","unstructured":"Graham DJ. Final Report: Liver Failure Risk With Troglitazone. Rockville, MD: Food and Drug Administration; 2000"},{"key":"2021121006393263600_R16","doi-asserted-by":"crossref","unstructured":"Sorrentino M, Powers T. Effectiveness of palivizumab: evaluation of outcomes from the 1998 to 1999 respiratory syncytial virus season. The Palivizumab Outcomes Study Group. Pediatr Infect Dis J.2000;19:1068\u20131071","DOI":"10.1097\/00006454-200011000-00007"},{"key":"2021121006393263600_R17","doi-asserted-by":"crossref","unstructured":"Weiss SR, Cook CE, Bradley LR, Manson JM. A pharmacist\u2019s guide to pregnancy registry studies. J Am Pharm Assoc.1999;39:830\u2013834","DOI":"10.1016\/S1086-5802(15)30374-0"},{"key":"2021121006393263600_R18","unstructured":"Moore TJ. The threat to cells. In: Prescription for Disaster. New York, NY: Simon & Schuster; 1998:94\u201395"},{"key":"2021121006393263600_R19","unstructured":"Food and Drug Administration. Center for Drug Evaluation and Research 2001 Report to the Nation: Improving Public Health Through Human Drugs. Rockville, MD: Food and Drug Administration; 2002"}],"container-title":["Pediatrics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/publications.aap.org\/pediatrics\/article-pdf\/110\/5\/e53\/1116496\/pe11020000i1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/publications.aap.org\/pediatrics\/article-pdf\/110\/5\/e53\/1116496\/pe11020000i1.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,1,14]],"date-time":"2024-01-14T05:08:24Z","timestamp":1705208904000},"score":1,"resource":{"primary":{"URL":"https:\/\/publications.aap.org\/pediatrics\/article\/110\/5\/e53\/64522\/Reported-Adverse-Drug-Events-in-Infants-and"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2002,11,1]]},"references-count":19,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2002,11,1]]},"published-print":{"date-parts":[[2002,11,1]]}},"URL":"https:\/\/doi.org\/10.1542\/peds.110.5.e53","relation":{},"ISSN":["0031-4005","1098-4275"],"issn-type":[{"value":"0031-4005","type":"print"},{"value":"1098-4275","type":"electronic"}],"subject":[],"published":{"date-parts":[[2002,11,1]]}}}