{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T05:23:24Z","timestamp":1791523404582,"version":"4.3.4"},"reference-count":29,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2019,6,15]],"date-time":"2019-06-15T00:00:00Z","timestamp":1560556800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100012399","name":"Biomedical Advanced Research and Development Authority","doi-asserted-by":"publisher","award":["HHSO100200600017C"],"award-info":[{"award-number":["HHSO100200600017C"]}],"id":[{"id":"10.13039\/100012399","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,4,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Botulism is a rare, life-threatening paralytic illness. Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine) (BAT) manufactured by Emergent BioSolutions Canada Inc is an equine-derived heptavalent botulinum antitoxin product indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A-G in adults and pediatric patients. BAT product was US-licensed in 2013.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In the United States, from October 2014 through July 2017, safety and clinical outcomes data were collected under a registry for patients treated with BAT product.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Registry patients had a median age of 51 years (range, 32 days to 92 years). Among 162 patients, 7 (4.3%) experienced BAT product\u2013related serious adverse events, including 1 (0.6%) report each of pneumonia, pneumonia aspiration, ventricular tachycardia, upper gastrointestinal hemorrhage, anaphylactic reaction, acute kidney injury, and acute myocardial infarction. Thirty-one (19.1%) patients had 41 BAT product\u2013related adverse events. Six (3.7%) deaths were reported in the registry. All deaths were attributed to the underlying illness and were assessed as unlikely related to BAT product. Among 113 (69.8%) patients with a final diagnosis of botulism, those treated early (\u22642 days) spent fewer days in the hospital (5 vs 15.5 days), in the intensive care unit (ICU) (4 vs 12 days), and on mechanical ventilation (6 vs 14.5 days) than those treated late (&amp;gt;2 days), respectively.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>BAT product was well tolerated in patients. Treatment with BAT product at \u22642 days of symptom onset was associated with shorter hospital and ICU stays, and shorter duration and need for mechanical ventilation, showing clinical benefit associated with early treatment.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciz515","type":"journal-article","created":{"date-parts":[[2019,6,14]],"date-time":"2019-06-14T19:14:56Z","timestamp":1560539696000},"page":"1950-1957","source":"Crossref","is-referenced-by-count":32,"title":["Safety and Clinical Outcomes of an Equine-derived Heptavalent Botulinum Antitoxin Treatment for Confirmed or Suspected Botulism in the United States"],"prefix":"10.1093","volume":"70","author":[{"given":"Jason S","family":"Richardson","sequence":"first","affiliation":[{"name":"Clinical Research Department, Emergent BioSolutions Canada, Inc., Winnipeg"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geraldine S","family":"Parrera","sequence":"first","affiliation":[{"name":"Pharmacovigilance Department, Emergent BioSolutions Canada, Inc., Winnipeg"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hugo","family":"Astacio","sequence":"first","affiliation":[{"name":"Pharmacovigilance Department, Emergent BioSolutions Canada, Inc., Winnipeg"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harpreet","family":"Sahota","sequence":"first","affiliation":[{"name":"Biostatistics Department, Emergent BioSolutions Canada, Inc., Winnipeg"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deborah M","family":"Anderson","sequence":"first","affiliation":[{"name":"Biostatistics Department, Emergent BioSolutions Canada, Inc., Winnipeg"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Hall","sequence":"first","affiliation":[{"name":"Clinical Research Department, Emergent BioSolutions Canada, Inc., Winnipeg"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tim","family":"Babinchak","sequence":"first","affiliation":[{"name":"Medical Affairs Department, Emergent BioSolutions, Inc., Gaithersburg, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2019,6,15]]},"reference":[{"key":"2020041501053769600_CIT0001","doi-asserted-by":"crossref","first-page":"221","DOI":"10.7326\/0003-4819-129-3-199808010-00011","article-title":"Botulism in the United States: a clinical and epidemiologic review","volume":"129","author":"Shapiro","year":"1998","journal-title":"Ann Intern Med"},{"key":"2020041501053769600_CIT0002","first-page":"1735","article-title":"[Botulism caused by inhalation.]","volume":"57","author":"Holzer","year":"1962","journal-title":"Med Klin"},{"key":"2020041501053769600_CIT0003","author":"Centers for Disease Control and Prevention"},{"key":"2020041501053769600_CIT0004","doi-asserted-by":"crossref","first-page":"113","DOI":"10.21236\/AD0443673","article-title":"Botulism: proceeding of a symposium","volume-title":"Botulism toxoids","author":"Cardella","year":"1964"},{"key":"2020041501053769600_CIT0005","doi-asserted-by":"crossref","first-page":"65","DOI":"10.1093\/cid\/cix827","article-title":"Workgroup report by the Joint Task Force Involving American Academy of Allergy, Asthma & Immunology (AAAAI); Food Allergy, Anaphylaxis, Dermatology and Drug Allergy (FADDA) (Adverse Reactions to Foods Committee and Adverse Reactions to Drugs, Biologicals, and Latex Committee); and the Centers for Disease Control and Prevention Botulism Clinical Treatment Guidelines Workgroup\u2014allergic reactions to botulinum antitoxin: a systematic review","volume":"66","author":"Schussler","year":"2017","journal-title":"Clin Infect Dis"},{"key":"2020041501053769600_CIT0006","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1093\/cid\/cix812","article-title":"Pediatric botulism and use of equine botulinum antitoxin in children: a systematic review","volume":"66","author":"Griese","year":"2017","journal-title":"Clin Infect Dis"},{"key":"2020041501053769600_CIT0007","doi-asserted-by":"crossref","first-page":"38","DOI":"10.1093\/cid\/cix814","article-title":"Clinical criteria to trigger suspicion for botulism: an evidence-based tool to facilitate timely recognition of suspected cases during sporadic events and outbreaks","volume":"66","author":"Rao","year":"2017","journal-title":"Clin Infect Dis"},{"key":"2020041501053769600_CIT0008","doi-asserted-by":"crossref","first-page":"S43","DOI":"10.1093\/cid\/cix815","article-title":"Efficacy of antitoxin therapy in treating patients with foodborne botulism: a systematic review and meta-analysis of cases, 1923\u20132016","volume":"66","author":"O\u2019Horo","year":"2017","journal-title":"Clin Infect Dis"},{"key":"2020041501053769600_CIT0009","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1093\/cid\/cix816","article-title":"Safety and improved clinical outcomes in patients treated with new equine-derived heptavalent botulinum antitoxin","volume":"66","author":"Yu","year":"2017","journal-title":"Clin Infect Dis"},{"key":"2020041501053769600_CIT0010","author":"BAT\u00ae [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)] Sterile Solution for Injection United States Prescribing Infomation (USPI)"},{"key":"2020041501053769600_CIT0011","doi-asserted-by":"crossref","first-page":"1059","DOI":"10.1001\/jama.285.8.1059","article-title":"Botulinum toxin as a biological weapon: medical and public health management","volume":"285","author":"Arnon","year":"2001","journal-title":"JAMA"},{"key":"2020041501053769600_CIT0012","doi-asserted-by":"crossref","first-page":"794","DOI":"10.1016\/0002-9343(84)90988-4","article-title":"Equine antitoxin use and other factors that predict outcome in type A foodborne botulism","volume":"76","author":"Tacket","year":"1984","journal-title":"Am J Med"},{"key":"2020041501053769600_CIT0013","doi-asserted-by":"crossref","first-page":"298","DOI":"10.1128\/CMR.19.2.298-314.2006","article-title":"Laboratory diagnostics of botulism","volume":"19","author":"Lindstr\u00f6m","year":"2006","journal-title":"Clin Microbiol Rev"},{"key":"2020041501053769600_CIT0014","doi-asserted-by":"crossref","first-page":"1363","DOI":"10.1074\/jbc.M209821200","article-title":"Evaluation of the therapeutic usefulness of botulinum neurotoxin B, C1, E, and F compared with the long lasting type A: basis for distinct durations of inhibition of exocytosis in central neurons","volume":"278","author":"Foran","year":"2003","journal-title":"J Biol Chem"},{"key":"2020041501053769600_CIT0015","author":"US Food and Drug Administration"},{"key":"2020041501053769600_CIT0016","author":"ICH Harmonized Tripartite Guidelines\u2014guideline for Good ClinicalPracticeE6(R1).","year":"1996"},{"key":"2020041501053769600_CIT0017","author":"US Food and Drug Administration. 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