{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T03:03:02Z","timestamp":1792292582061,"version":"4.4.0"},"reference-count":18,"publisher":"Oxford University Press (OUP)","issue":"Supplement_1","license":[{"start":{"date-parts":[[2019,8,1]],"date-time":"2019-08-01T00:00:00Z","timestamp":1564617600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Omadacycline is a semisynthetic tetracycline antibiotic. Phase III clinical trial results have shown that omadacycline has an acceptable safety profile in the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. Similar to most tetracyclines, transient nausea and vomiting and low-magnitude increases in liver aminotransferases were the most frequent treatment-emergent adverse events in phase III studies but were not treatment limiting. Package insert warnings and precautions for omadacycline include tooth discoloration; enamel hypoplasia; inhibition of bone growth following use in late pregnancy, infancy, or childhood up to 8 years of age; an imbalance in mortality (2%, compared with 1% in moxifloxacin-treated patients) was observed in the phase III study in patients with community-acquired bacterial pneumonia. Omadacycline has no effect on the QT interval, and its affinity for muscarinic M2 receptors resulted in transient heart rate increases following dosing.<\/jats:p>","DOI":"10.1093\/cid\/ciz398","type":"journal-article","created":{"date-parts":[[2019,5,13]],"date-time":"2019-05-13T19:13:24Z","timestamp":1557774804000},"page":"S40-S47","source":"Crossref","is-referenced-by-count":45,"title":["An Integrated Safety Summary of Omadacycline, a Novel Aminomethylcycline Antibiotic"],"prefix":"10.1093","volume":"69","author":[{"given":"Steven","family":"Opal","sequence":"first","affiliation":[{"name":"Warren Alpert Medical School of Brown University, Providence, Rhode Island"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr","given":"Thomas M","family":"File","sequence":"additional","affiliation":[{"name":"Summa Health, Akron"},{"name":"Northeast Ohio Medical University, Rootstown, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom","family":"van der Poll","sequence":"additional","affiliation":[{"name":"Center for Experimental and Molecular Medicine"},{"name":"Division of Infectious Diseases, Amsterdam University Medical Centers, Academic Medical Center, University of Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evan","family":"Tzanis","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Surya","family":"Chitra","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul C","family":"McGovern","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2019,8,1]]},"reference":[{"key":"2019080101102787300_CIT0001","doi-asserted-by":"crossref","first-page":"1421","DOI":"10.2217\/fmb-2016-0100","article-title":"Omadacycline: development of a novel aminomethylcycline antibiotic for treating drug-resistant bacterial infections","volume":"11","author":"Villano","year":"2016","journal-title":"Future Microbiol"},{"key":"2019080101102787300_CIT0002","doi-asserted-by":"crossref","first-page":"1279","DOI":"10.1128\/AAC.01066-13","article-title":"Mechanism of action of the novel aminomethylcycline antibiotic omadacycline","volume":"58","author":"Draper","year":"2014","journal-title":"Antimicrob Agents Chemother"},{"key":"2019080101102787300_CIT0003","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1111\/j.1749-6632.2011.06354.x","article-title":"The history of the tetracyclines","volume":"1241","author":"Nelson","year":"2011","journal-title":"Ann N Y Acad Sci"},{"key":"2019080101102787300_CIT0004","doi-asserted-by":"crossref","first-page":"571","DOI":"10.1517\/14740338.7.5.571","article-title":"The use and safety of doxycycline hyclate and other second-generation tetracyclines","volume":"7","author":"Sloan","year":"2008","journal-title":"Expert Opin Drug Saf"},{"key":"2019080101102787300_CIT0005","doi-asserted-by":"crossref","first-page":"528","DOI":"10.1056\/NEJMoa1800170","article-title":"Omadacycline for acute bacterial skin and skin-structure infections","volume":"380","author":"O\u2019Riordan","year":"2019","journal-title":"N Engl J Med"},{"key":"2019080101102787300_CIT0006","unstructured":"O\u2019Riordan W , CardenasC, SirbuA, et al A phase 3 randomized, double-blind, multi-centre study to compare the safety and efficacy of oral omadacycline to oral linezolid for treating adult subjects with ABSSSI (OASIS-2 study). In: 28th European Congress of Clinical Microbiology and Infectious Diseases, Madrid, Spain,21\u201324 April 2018."},{"key":"2019080101102787300_CIT0007","doi-asserted-by":"crossref","first-page":"517","DOI":"10.1056\/NEJMoa1800201","article-title":"Omadacycline for community-acquired bacterial pneumonia","volume":"380","author":"Stets","year":"2019","journal-title":"N Engl J Med"},{"key":"2019080101102787300_CIT0008","doi-asserted-by":"crossref","first-page":"1951","DOI":"10.1093\/jac\/dkt129","article-title":"Community-associated Clostridium difficile infection and antibiotics: a meta-analysis","volume":"68","author":"Deshpande","year":"2013","journal-title":"J Antimicrob Chemother"},{"key":"2019080101102787300_CIT0009","doi-asserted-by":"crossref","first-page":"615","DOI":"10.1093\/cid\/cis457","article-title":"Does doxycycline protect against development of Clostridium difficile infection?","volume":"55","author":"Doernberg","year":"2012","journal-title":"Clin Infect Dis"},{"key":"2019080101102787300_CIT0010","doi-asserted-by":"crossref","first-page":"881","DOI":"10.1093\/jac\/dkt477","article-title":"Antibiotics and hospital-acquired Clostridium difficile infection: update of systematic review and meta-analysis","volume":"69","author":"Slimings","year":"2014","journal-title":"J Antimicrob Chemother"},{"key":"2019080101102787300_CIT0011","doi-asserted-by":"crossref","unstructured":"Kim O , LeahyRG, TraczewskiM, MaconeA, SteenbergenJ, TanakaSK. 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