PMID- 30512122
OWN - NLM
STAT- MEDLINE
DCOM- 20190813
LR  - 20190813
IS  - 1541-8243 (Electronic)
IS  - 0038-4348 (Linking)
VI  - 111
IP  - 12
DP  - 2018 Dec
TI  - Adverse Events in the Efficacy of Crotalidae Polyvalent Immune Fab Antivenom vs 
      Placebo in Recovery from Copperhead Snakebite Trial.
PG  - 716-720
LID - 10.14423/SMJ.0000000000000902 [doi]
AB  - 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.
FAU - Mullins, Michael E
AU  - Mullins ME
AD  - 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.
FAU - Gerardo, Charles J
AU  - Gerardo CJ
AD  - 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.
FAU - Bush, Sean P
AU  - Bush SP
AD  - 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.
FAU - Rose, S Rutherfoord
AU  - Rose SR
AD  - 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.
FAU - Greene, Spencer
AU  - Greene S
AD  - 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.
FAU - Quackenbush, Eugenia B
AU  - Quackenbush EB
AD  - 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.
FAU - Lewis, Brandon
AU  - Lewis B
AD  - 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.
FAU - Anderson, Victoria E
AU  - Anderson VE
AD  - 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.
FAU - Kleinschmidt, Kurt C
AU  - Kleinschmidt KC
AD  - 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.
FAU - Schwarz, Richard B
AU  - Schwarz RB
AD  - 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.
FAU - Charlton, Nathan P
AU  - Charlton NP
AD  - 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.
FAU - Toschlog, Eric A
AU  - Toschlog EA
AD  - 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.
FAU - Sharma, Kapil
AU  - Sharma K
AD  - 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.
FAU - Denning, David A
AU  - Denning DA
AD  - 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.
FAU - Lavonas, Eric J
AU  - Lavonas EJ
AD  - 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.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - South Med J
JT  - Southern medical journal
JID - 0404522
RN  - 0 (Antivenins)
RN  - 0 (Crotalidae Polyvalent immune Fab)
RN  - 0 (Immunoglobulin Fab Fragments)
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - *Agkistrodon
MH  - Animals
MH  - Antivenins/*adverse effects/therapeutic use
MH  - Child
MH  - Double-Blind Method
MH  - Drug Hypersensitivity/epidemiology/*etiology
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Immunoglobulin Fab Fragments/*adverse effects/therapeutic use
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Snake Bites/*drug therapy
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2018/12/05 06:00
MHDA- 2019/08/14 06:00
CRDT- 2018/12/05 06:00
PHST- 2018/12/05 06:00 [entrez]
PHST- 2018/12/05 06:00 [pubmed]
PHST- 2019/08/14 06:00 [medline]
AID - SMJ50635 [pii]
AID - 10.14423/SMJ.0000000000000902 [doi]
PST - ppublish
SO  - South Med J. 2018 Dec;111(12):716-720. doi: 10.14423/SMJ.0000000000000902.