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Adverse Events in the Efficacy of Crotalidae Polyvalent Immune Fab Antivenom vs Placebo in Recovery from Copperhead Snakebite Trial.
South Med J. 2018 12; 111(12):716-720.SM

Abstract

OBJECTIVE

To compare the incidence of hypersensitivity reactions following copperhead envenomation treated with Fab antivenom (FabAV) or placebo.

METHODS

Patients with copperhead snakebites received treatment and follow-up in a prospective, randomized, double-blind, placebo-controlled trial of FabAV or placebo. The treatment allocation ratio was 2:1 (FabAV:placebo). All of the included patients received at least one dose of study treatment. We reviewed all treatment-emergent adverse events (AEs) using a previously published scale to classify likely hypersensitivity reactions as mild, moderate, or severe.

RESULTS

We enrolled 74 patients at 13 sites. Forty-five patients received FabAV, and 29 patients received placebo. Five FabAV patients and 4 placebo patients had moderate envenomations; the rest were mild. Twenty-five FabAV patients and 8 placebo patients had at least 1 AE. Mild skin reactions occurred in 11 (24%) FabAV patients (pruritis, urticaria, rash, ecchymosis, erythema) and 1 (3%) placebo patient (pruritis). Moderate gastrointestinal AEs occurred in 7 (16%) FabAV patients (nausea, vomiting, constipation, diarrhea, oral paresthesia) and in 2 (7%) placebo patients (nausea). Respiratory AEs occurred in 3 (7%) FabAV patients (dyspnea, pulmonary embolism, nasal congestion, sneezing) and no placebo patients. Hypotension occurred in 1 patient in each group.

CONCLUSIONS

In a randomized controlled trial of FabAV for copperhead bites, the incidence of hypersensitivity reactions was low. Most reactions were mild skin reactions.

Authors+Show Affiliations

From the Division of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri, the Division of Emergency Medicine, Duke University, Durham, North Carolina, the Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, the Department of Emergency Medicine, Virginia Commonwealth University, Richmond, the Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, the Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, Texas A&M Health Sciences Center, Bryan, Rocky Mountain Poison & Drug Center, Denver, Colorado, the Department of Emergency Medicine, UT Southwestern Medical Center, Dallas, Texas, the Department of Emergency Medicine, Augusta University, Augusta, Georgia, the Department of Emergency Medicine, University of Virginia, Charlottesville, the Department of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, and the Department of Surgery, Marshall University, Huntington, West Virginia.From the Division of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri, the Division of Emergency Medicine, Duke University, Durham, North Carolina, the Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, the Department of Emergency Medicine, Virginia Commonwealth University, Richmond, the Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, the Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, Texas A&M Health Sciences Center, Bryan, Rocky Mountain Poison & Drug Center, Denver, Colorado, the Department of Emergency Medicine, UT Southwestern Medical Center, Dallas, Texas, the Department of Emergency Medicine, Augusta University, Augusta, Georgia, the Department of Emergency Medicine, University of Virginia, Charlottesville, the Department of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, and the Department of Surgery, Marshall University, Huntington, West Virginia.From the Division of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri, the Division of Emergency Medicine, Duke University, Durham, North Carolina, the Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, the Department of Emergency Medicine, Virginia Commonwealth University, Richmond, the Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, the Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, Texas A&M Health Sciences Center, Bryan, Rocky Mountain Poison & Drug Center, Denver, Colorado, the Department of Emergency Medicine, UT Southwestern Medical Center, Dallas, Texas, the Department of Emergency Medicine, Augusta University, Augusta, Georgia, the Department of Emergency Medicine, University of Virginia, Charlottesville, the Department of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, and the Department of Surgery, Marshall University, Huntington, West Virginia.From the Division of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri, the Division of Emergency Medicine, Duke University, Durham, North Carolina, the Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, the Department of Emergency Medicine, Virginia Commonwealth University, Richmond, the Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, the Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, Texas A&M Health Sciences Center, Bryan, Rocky Mountain Poison & Drug Center, Denver, Colorado, the Department of Emergency Medicine, UT Southwestern Medical Center, Dallas, Texas, the Department of Emergency Medicine, Augusta University, Augusta, Georgia, the Department of Emergency Medicine, University of Virginia, Charlottesville, the Department of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, and the Department of Surgery, Marshall University, Huntington, West Virginia.From the Division of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri, the Division of Emergency Medicine, Duke University, Durham, North Carolina, the Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, the Department of Emergency Medicine, Virginia Commonwealth University, Richmond, the Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, the Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, Texas A&M Health Sciences Center, Bryan, Rocky Mountain Poison & Drug Center, Denver, Colorado, the Department of Emergency Medicine, UT Southwestern Medical Center, Dallas, Texas, the Department of Emergency Medicine, Augusta University, Augusta, Georgia, the Department of Emergency Medicine, University of Virginia, Charlottesville, the Department of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, and the Department of Surgery, Marshall University, Huntington, West Virginia.From the Division of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri, the Division of Emergency Medicine, Duke University, Durham, North Carolina, the Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, the Department of Emergency Medicine, Virginia Commonwealth University, Richmond, the Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, the Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, Texas A&M Health Sciences Center, Bryan, Rocky Mountain Poison & Drug Center, Denver, Colorado, the Department of Emergency Medicine, UT Southwestern Medical Center, Dallas, Texas, the Department of Emergency Medicine, Augusta University, Augusta, Georgia, the Department of Emergency Medicine, University of Virginia, Charlottesville, the Department of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, and the Department of Surgery, Marshall University, Huntington, West Virginia.From the Division of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri, the Division of Emergency Medicine, Duke University, Durham, North Carolina, the Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, the Department of Emergency Medicine, Virginia Commonwealth University, Richmond, the Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, the Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, Texas A&M Health Sciences Center, Bryan, Rocky Mountain Poison & Drug Center, Denver, Colorado, the Department of Emergency Medicine, UT Southwestern Medical Center, Dallas, Texas, the Department of Emergency Medicine, Augusta University, Augusta, Georgia, the Department of Emergency Medicine, University of Virginia, Charlottesville, the Department of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, and the Department of Surgery, Marshall University, Huntington, West Virginia.From the Division of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri, the Division of Emergency Medicine, Duke University, Durham, North Carolina, the Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, the Department of Emergency Medicine, Virginia Commonwealth University, Richmond, the Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, the Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, Texas A&M Health Sciences Center, Bryan, Rocky Mountain Poison & Drug Center, Denver, Colorado, the Department of Emergency Medicine, UT Southwestern Medical Center, Dallas, Texas, the Department of Emergency Medicine, Augusta University, Augusta, Georgia, the Department of Emergency Medicine, University of Virginia, Charlottesville, the Department of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, and the Department of Surgery, Marshall University, Huntington, West Virginia.From the Division of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri, the Division of Emergency Medicine, Duke University, Durham, North Carolina, the Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, the Department of Emergency Medicine, Virginia Commonwealth University, Richmond, the Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, the Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, Texas A&M Health Sciences Center, Bryan, Rocky Mountain Poison & Drug Center, Denver, Colorado, the Department of Emergency Medicine, UT Southwestern Medical Center, Dallas, Texas, the Department of Emergency Medicine, Augusta University, Augusta, Georgia, the Department of Emergency Medicine, University of Virginia, Charlottesville, the Department of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, and the Department of Surgery, Marshall University, Huntington, West Virginia.From the Division of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri, the Division of Emergency Medicine, Duke University, Durham, North Carolina, the Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, the Department of Emergency Medicine, Virginia Commonwealth University, Richmond, the Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, the Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, Texas A&M Health Sciences Center, Bryan, Rocky Mountain Poison & Drug Center, Denver, Colorado, the Department of Emergency Medicine, UT Southwestern Medical Center, Dallas, Texas, the Department of Emergency Medicine, Augusta University, Augusta, Georgia, the Department of Emergency Medicine, University of Virginia, Charlottesville, the Department of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, and the Department of Surgery, Marshall University, Huntington, West Virginia.From the Division of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri, the Division of Emergency Medicine, Duke University, Durham, North Carolina, the Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, the Department of Emergency Medicine, Virginia Commonwealth University, Richmond, the Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, the Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, Texas A&M Health Sciences Center, Bryan, Rocky Mountain Poison & Drug Center, Denver, Colorado, the Department of Emergency Medicine, UT Southwestern Medical Center, Dallas, Texas, the Department of Emergency Medicine, Augusta University, Augusta, Georgia, the Department of Emergency Medicine, University of Virginia, Charlottesville, the Department of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, and the Department of Surgery, Marshall University, Huntington, West Virginia.From the Division of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri, the Division of Emergency Medicine, Duke University, Durham, North Carolina, the Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, the Department of Emergency Medicine, Virginia Commonwealth University, Richmond, the Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, the Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, Texas A&M Health Sciences Center, Bryan, Rocky Mountain Poison & Drug Center, Denver, Colorado, the Department of Emergency Medicine, UT Southwestern Medical Center, Dallas, Texas, the Department of Emergency Medicine, Augusta University, Augusta, Georgia, the Department of Emergency Medicine, University of Virginia, Charlottesville, the Department of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, and the Department of Surgery, Marshall University, Huntington, West Virginia.From the Division of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri, the Division of Emergency Medicine, Duke University, Durham, North Carolina, the Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, the Department of Emergency Medicine, Virginia Commonwealth University, Richmond, the Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, the Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, Texas A&M Health Sciences Center, Bryan, Rocky Mountain Poison & Drug Center, Denver, Colorado, the Department of Emergency Medicine, UT Southwestern Medical Center, Dallas, Texas, the Department of Emergency Medicine, Augusta University, Augusta, Georgia, the Department of Emergency Medicine, University of Virginia, Charlottesville, the Department of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, and the Department of Surgery, Marshall University, Huntington, West Virginia.From the Division of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri, the Division of Emergency Medicine, Duke University, Durham, North Carolina, the Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, the Department of Emergency Medicine, Virginia Commonwealth University, Richmond, the Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, the Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, Texas A&M Health Sciences Center, Bryan, Rocky Mountain Poison & Drug Center, Denver, Colorado, the Department of Emergency Medicine, UT Southwestern Medical Center, Dallas, Texas, the Department of Emergency Medicine, Augusta University, Augusta, Georgia, the Department of Emergency Medicine, University of Virginia, Charlottesville, the Department of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, and the Department of Surgery, Marshall University, Huntington, West Virginia.From the Division of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri, the Division of Emergency Medicine, Duke University, Durham, North Carolina, the Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, the Department of Emergency Medicine, Virginia Commonwealth University, Richmond, the Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, the Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, Texas A&M Health Sciences Center, Bryan, Rocky Mountain Poison & Drug Center, Denver, Colorado, the Department of Emergency Medicine, UT Southwestern Medical Center, Dallas, Texas, the Department of Emergency Medicine, Augusta University, Augusta, Georgia, the Department of Emergency Medicine, University of Virginia, Charlottesville, the Department of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, and the Department of Surgery, Marshall University, Huntington, West Virginia.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

30512122

Citation

Mullins, Michael E., et al. "Adverse Events in the Efficacy of Crotalidae Polyvalent Immune Fab Antivenom Vs Placebo in Recovery From Copperhead Snakebite Trial." Southern Medical Journal, vol. 111, no. 12, 2018, pp. 716-720.
Mullins ME, Gerardo CJ, Bush SP, et al. Adverse Events in the Efficacy of Crotalidae Polyvalent Immune Fab Antivenom vs Placebo in Recovery from Copperhead Snakebite Trial. South Med J. 2018;111(12):716-720.
Mullins, M. E., Gerardo, C. J., Bush, S. P., Rose, S. R., Greene, S., Quackenbush, E. B., Lewis, B., Anderson, V. E., Kleinschmidt, K. C., Schwarz, R. B., Charlton, N. P., Toschlog, E. A., Sharma, K., Denning, D. A., & Lavonas, E. J. (2018). Adverse Events in the Efficacy of Crotalidae Polyvalent Immune Fab Antivenom vs Placebo in Recovery from Copperhead Snakebite Trial. Southern Medical Journal, 111(12), 716-720. https://doi.org/10.14423/SMJ.0000000000000902
Mullins ME, et al. Adverse Events in the Efficacy of Crotalidae Polyvalent Immune Fab Antivenom Vs Placebo in Recovery From Copperhead Snakebite Trial. South Med J. 2018;111(12):716-720. PubMed PMID: 30512122.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Adverse Events in the Efficacy of Crotalidae Polyvalent Immune Fab Antivenom vs Placebo in Recovery from Copperhead Snakebite Trial. AU - Mullins,Michael E, AU - Gerardo,Charles J, AU - Bush,Sean P, AU - Rose,S Rutherfoord, AU - Greene,Spencer, AU - Quackenbush,Eugenia B, AU - Lewis,Brandon, AU - Anderson,Victoria E, AU - Kleinschmidt,Kurt C, AU - Schwarz,Richard B, AU - Charlton,Nathan P, AU - Toschlog,Eric A, AU - Sharma,Kapil, AU - Denning,David A, AU - Lavonas,Eric J, PY - 2018/12/5/entrez PY - 2018/12/5/pubmed PY - 2019/8/14/medline SP - 716 EP - 720 JF - Southern medical journal JO - South. Med. J. VL - 111 IS - 12 N2 - OBJECTIVE: To compare the incidence of hypersensitivity reactions following copperhead envenomation treated with Fab antivenom (FabAV) or placebo. METHODS: Patients with copperhead snakebites received treatment and follow-up in a prospective, randomized, double-blind, placebo-controlled trial of FabAV or placebo. The treatment allocation ratio was 2:1 (FabAV:placebo). All of the included patients received at least one dose of study treatment. We reviewed all treatment-emergent adverse events (AEs) using a previously published scale to classify likely hypersensitivity reactions as mild, moderate, or severe. RESULTS: We enrolled 74 patients at 13 sites. Forty-five patients received FabAV, and 29 patients received placebo. Five FabAV patients and 4 placebo patients had moderate envenomations; the rest were mild. Twenty-five FabAV patients and 8 placebo patients had at least 1 AE. Mild skin reactions occurred in 11 (24%) FabAV patients (pruritis, urticaria, rash, ecchymosis, erythema) and 1 (3%) placebo patient (pruritis). Moderate gastrointestinal AEs occurred in 7 (16%) FabAV patients (nausea, vomiting, constipation, diarrhea, oral paresthesia) and in 2 (7%) placebo patients (nausea). Respiratory AEs occurred in 3 (7%) FabAV patients (dyspnea, pulmonary embolism, nasal congestion, sneezing) and no placebo patients. Hypotension occurred in 1 patient in each group. CONCLUSIONS: In a randomized controlled trial of FabAV for copperhead bites, the incidence of hypersensitivity reactions was low. Most reactions were mild skin reactions. SN - 1541-8243 UR - https://www.unboundmedicine.com/medline/citation/30512122/Adverse_Events_in_the_Efficacy_of_Crotalidae_Polyvalent_Immune_Fab_Antivenom_vs_Placebo_in_Recovery_from_Copperhead_Snakebite_Trial_ L2 - http://dx.doi.org/10.14423/SMJ.0000000000000902 DB - PRIME DP - Unbound Medicine ER -