{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T15:21:17Z","timestamp":1781796077484,"version":"3.54.5"},"reference-count":33,"publisher":"SAGE Publications","issue":"10","license":[{"start":{"date-parts":[[2025,2,26]],"date-time":"2025-02-26T00:00:00Z","timestamp":1740528000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>The US Food and Drug Administration (FDA) has raised concerns about a potential link between trimethoprim\/sulfamethoxazole (TMP-SMX) and an increased risk of acute respiratory failure\/acute respiratory distress syndrome (ARF\/ARDS) in healthy adolescents and young adults.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To assess the association between TMP-SMX and the risk of ARF\/ARDS using data from the FDA Adverse Event Reporting System (FAERS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      We analyzed adverse drug events (ADEs) reported in FAERS from January 1, 2004, to December 31, 2023. We focused on reports where TMP-SMX, amoxicillin-clavulanic acid, or azithromycin were the primary suspect drugs for ADEs in individuals aged 10 to 24 years. The outcomes of interest\u2014ARF\/ARDS\u2014were identified using MedDRA-preferred terms. We used an active comparator-restricted disproportionality analysis (ACR-DA) to estimate the reporting odds ratio (ROR) and 95% confidence interval (CI), adjusting for age, sex, acne, and urinary tract infections. Bayesian Confidence Propagation Neural Networks (BCPNN) were used to calculate the Information Components (IC\n                      <jats:sub>025<\/jats:sub>\n                      ). Due to the amount of missing information, a case-by-case analysis could not be performed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      3171 ICSRs (810 for TMP-SMX, 1617 for azithromycin, and 744 for amoxicillin-clavulanic acid) were included in the study. ACR-DA showed an unadjusted 8-fold increase in the reports of ARF\/ARDS with TMP-SMX compared with azithromycin (unadjusted ROR, 7.98; 95% CI, 4.09 to 15.60) and an adjusted 3-fold increase after adjustment for age, sex, acne, and urinary tract infection (adjusted ROR, 2.80; 95% CI, 1.28 to 6.11). BCPNN analysis confirmed significant disproportionality (IC\n                      <jats:sub>025<\/jats:sub>\n                      , 0.75). No cases of ARF\/ARDS were reported for amoxicillin-clavulanic acid.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion and Relevance:<\/jats:title>\n                    <jats:p>TMP-SMX may increase the risk of ARF\/ARDS, requiring further validation in larger pharmacoepidemiological studies. Our findings lay the groundwork for future research to further investigate the safety profile of TMP-SMX in adolescent populations. If confirmed, prescribers should exercise greater caution when prescribing TMP-SMX to adolescents and young adults.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280251320690","type":"journal-article","created":{"date-parts":[[2025,2,27]],"date-time":"2025-02-27T01:26:51Z","timestamp":1740619611000},"page":"904-911","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["Severe Acute Respiratory Failure Associated With Trimethoprim\/Sulfamethoxazole Among Adolescent and Young Adults: An Active Comparator-Restricted Disproportionality Analysis From the FDA Adverse Event Reporting System (FAERS) Database"],"prefix":"10.1177","volume":"59","author":[{"given":"Fatemeh","family":"Ahmadi","sequence":"first","affiliation":[{"name":"ICES, London, ON, Canada"},{"name":"Department of Epidemiology and Biostatistics, Western University, London, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niaz","family":"Chalabianloo","sequence":"additional","affiliation":[{"name":"ICES, London, ON, Canada"},{"name":"Department of Physiology and Pharmacology, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"McArthur","sequence":"additional","affiliation":[{"name":"ICES, London, ON, Canada"},{"name":"Lawson Health Research Institute, London Health Sciences Centre, London, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6847-0699","authenticated-orcid":false,"given":"Mohammad Ali","family":"Omrani","sequence":"additional","affiliation":[{"name":"Department of Physiology and Pharmacology, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheikh S.","family":"Abdullah","sequence":"additional","affiliation":[{"name":"ICES, London, ON, Canada"},{"name":"Lawson Health Research Institute, London Health Sciences Centre, London, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Facundo","family":"Garcia-Bournissen","sequence":"additional","affiliation":[{"name":"Department of Physiology and Pharmacology, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada"},{"name":"Division of Paediatric Clinical Pharmacology, Department of Paediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4682-6564","authenticated-orcid":false,"given":"Flory T","family":"Muanda","sequence":"additional","affiliation":[{"name":"ICES, London, ON, Canada"},{"name":"Department of Epidemiology and Biostatistics, Western University, London, ON, Canada"},{"name":"Department of Physiology and Pharmacology, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada"},{"name":"Lawson Health Research Institute, London Health Sciences Centre, London, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,2,26]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1086\/320532"},{"issue":"4","key":"e_1_3_2_3_2","first-page":"1","article-title":"Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents","volume":"58","author":"Kaplan JE","year":"2009","unstructured":"Kaplan JE, Benson C, Holmes KK, et al Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents. MMWR Recomm Rep. 2009;58(4):1-207.","journal-title":"MMWR Recomm Rep"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciq257"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2018-3242"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.202009-3421LE"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0000000000006002"},{"key":"e_1_3_2_8_2","unstructured":"New labeling on TMP-SMX products warns of acute respiratory failure. Food and Drug Administration\u2019s Office of Pediatric Therapeutics and Center for Drug Evaluation and Research Division of Pediatric and Maternal Health Division of Anti-Infectives and Office of Surveillance and Epidemiology. Accessed August 7 2024. https:\/\/www.fda.gov\/media\/150781\/download"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2011.04037.x"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15178"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1742"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-024-01423-7"},{"key":"e_1_3_2_13_2","unstructured":"U.S. Food and Drug Administration. openFDA. FDA adverse event reporting system (FAERS) public dashboard. Accessed September 9 2024. https:\/\/open.fda.gov\/"},{"key":"e_1_3_2_14_2","first-page":"1","article-title":"Maintenance of the ICH guideline on clinical safety data management: data elements for transmission of individual case safety reports E2B (R2)","volume":"4","author":"Guideline IHT.","year":"2001","unstructured":"Guideline IHT. Maintenance of the ICH guideline on clinical safety data management: data elements for transmission of individual case safety reports E2B (R2). Curr Step. 2001;4:1-29.","journal-title":"Curr Step"},{"key":"e_1_3_2_15_2","unstructured":"U.S. Food and Drug Administration. Questions and answers on FDA\u2019s adverse event reporting system (FAERS) FDA. Accessed September 9 2024. https:\/\/www.fda.gov\/drugs\/surveillance\/questions-and-answers-fdas-adverse-event-reporting-system-faers"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1093\/jamia\/ocv153"},{"key":"e_1_3_2_17_2","unstructured":"Open FDA. OpenFDA API basics. Accessed September 9 2024. https:\/\/open.fda.gov\/apis\/"},{"key":"e_1_3_2_18_2","unstructured":"Open FDA. Data licensing. Accessed September 9 2024. https:\/\/open.fda.gov\/license\/"},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.3233\/978-1-61499-564-7-574"},{"key":"e_1_3_2_20_2","unstructured":"RxNorm. Unified Medical Language System\u00ae\u2009(UMLS\u00ae). Accessed January 4 2025. https:\/\/www.nlm.nih.gov\/research\/umls\/rxnorm\/index.html"},{"key":"e_1_3_2_21_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-014-1658-1"},{"key":"e_1_3_2_22_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40471-015-0053-5"},{"key":"e_1_3_2_23_2","doi-asserted-by":"publisher","DOI":"10.1007\/s002280050466"},{"key":"e_1_3_2_24_2","doi-asserted-by":"publisher","DOI":"10.3389\/fdsfr.2023.1323057"},{"key":"e_1_3_2_25_2","volume-title":"In: B48. Toxicology and Other Medications in the ICU: Case Reports","author":"Muradashvili T","unstructured":"Muradashvili T, Medhat G, Matcharashvili R, Ahmed M, Syndey S. Suspected trimethoprim-sulfamethoxazole induced lung injury in a healthy adult female. In: B48. Toxicology and Other Medications in the ICU: Case Reports. American Thoracic Society; 2023:A3510-A3510."},{"key":"e_1_3_2_26_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.chest.2022.08.762"},{"key":"e_1_3_2_27_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41397-022-00266-8"},{"key":"e_1_3_2_28_2","doi-asserted-by":"publisher","DOI":"10.1503\/cmaj.111152"},{"key":"e_1_3_2_29_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-023-01329-w"},{"key":"e_1_3_2_30_2","unstructured":"Search criteria. Drug product database online query. Government of Canada. Accessed December 5 2024. https:\/\/health-products.canada.ca\/dpd-bdpp\/"},{"key":"e_1_3_2_31_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-020-00911-w"},{"key":"e_1_3_2_32_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40290-021-00398-5"},{"key":"e_1_3_2_33_2","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3529"},{"key":"e_1_3_2_34_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2021.06.022"}],"container-title":["Annals of Pharmacotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10600280251320690","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/10600280251320690","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10600280251320690","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T11:14:02Z","timestamp":1777374842000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/10600280251320690"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2,26]]},"references-count":33,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2025,10]]}},"alternative-id":["10.1177\/10600280251320690"],"URL":"https:\/\/doi.org\/10.1177\/10600280251320690","relation":{},"ISSN":["1060-0280","1542-6270"],"issn-type":[{"value":"1060-0280","type":"print"},{"value":"1542-6270","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2,26]]}}}