title: Absence of bacterial or fungal growth in vials of reconstituted botulinum toxin type A after storage.
abstract: BACKGROUND
  Botulinum toxin type A (BTX-A; Botox) is supplied as individual freeze-dried preparations that should be administered within 24 hours after reconstitution. To avoid wasting this expensive drug, some physicians have resorted to storing vials of reconstituted BTX-A beyond the recommended duration. However, there is insufficient evidence to indicate that the sterility of previously reconstituted BTX-A is maintained during storage.
  
  
  OBJECTIVE
  The authors sought to determine whether bacterial and/or fungal proliferation occurred in vials of reconstituted BTX-A and subsequent storage of the remaining solution under refrigeration for 4 weeks.
  
  
  METHODS
  A portion of the contents of 88 consecutive 100-U vials of BTX-A was administered aseptically to 108 patients for essential blepharospasm, hemifacial spasm, or facial rejuvenation. The vials were then stored for 4 weeks in a refrigerator, after which the contents were transferred to various media (blood agar, chocolate agar, Sabouraud agar, brain-heart infusion medium, and thioglycolate broth) and assessed for bacterial and/or fungal growth by standard methods.
  
  
  RESULTS
  None of the BTX-A vials contained detectable bacterial or fungal contamination after 4 weeks of storage.
  
  
  CONCLUSIONS
  Storing vials of reconstituted BTX-A for 4 weeks after administration to patients was not associated with detectable growth of bacteria or fungi.
authors.affiliation: Drs T. Osaki, M.H. Osaki, T.H. Osaki and A.E. Sant'Anna are from Division of Ophthalmic Plastic Surgery, Department of Ophthalmology and Visual Sciences, Federal University of São Paulo, São Paulo, Brazil. Drs M. Cecilia and A.L. Hofling-Lima are from Department of Ophthalmology and Visual Sciences, Federal University of São Paulo, São Paulo, Brazil.
authors.forename: Teissy
authors.initials: T
authors.lastname: Osaki
authors.affiliation: Drs T. Osaki, M.H. Osaki, T.H. Osaki and A.E. Sant'Anna are from Division of Ophthalmic Plastic Surgery, Department of Ophthalmology and Visual Sciences, Federal University of São Paulo, São Paulo, Brazil. Drs M. Cecilia and A.L. Hofling-Lima are from Department of Ophthalmology and Visual Sciences, Federal University of São Paulo, São Paulo, Brazil.
authors.forename: Midori H
authors.initials: MH
authors.lastname: Osaki
authors.affiliation: Drs T. Osaki, M.H. Osaki, T.H. Osaki and A.E. Sant'Anna are from Division of Ophthalmic Plastic Surgery, Department of Ophthalmology and Visual Sciences, Federal University of São Paulo, São Paulo, Brazil. Drs M. Cecilia and A.L. Hofling-Lima are from Department of Ophthalmology and Visual Sciences, Federal University of São Paulo, São Paulo, Brazil.
authors.forename: Tammy H
authors.initials: TH
authors.lastname: Osaki
authors.affiliation: Drs T. Osaki, M.H. Osaki, T.H. Osaki and A.E. Sant'Anna are from Division of Ophthalmic Plastic Surgery, Department of Ophthalmology and Visual Sciences, Federal University of São Paulo, São Paulo, Brazil. Drs M. Cecilia and A.L. Hofling-Lima are from Department of Ophthalmology and Visual Sciences, Federal University of São Paulo, São Paulo, Brazil.
authors.forename: Ana Estela
authors.initials: AE
authors.lastname: Sant'Anna
authors.affiliation: Drs T. Osaki, M.H. Osaki, T.H. Osaki and A.E. Sant'Anna are from Division of Ophthalmic Plastic Surgery, Department of Ophthalmology and Visual Sciences, Federal University of São Paulo, São Paulo, Brazil. Drs M. Cecilia and A.L. Hofling-Lima are from Department of Ophthalmology and Visual Sciences, Federal University of São Paulo, São Paulo, Brazil.
authors.forename: Maria Cecilia Z
authors.initials: MC
authors.lastname: Yu
authors.affiliation: Drs T. Osaki, M.H. Osaki, T.H. Osaki and A.E. Sant'Anna are from Division of Ophthalmic Plastic Surgery, Department of Ophthalmology and Visual Sciences, Federal University of São Paulo, São Paulo, Brazil. Drs M. Cecilia and A.L. Hofling-Lima are from Department of Ophthalmology and Visual Sciences, Federal University of São Paulo, São Paulo, Brazil.
authors.forename: Ana Luisa
authors.initials: AL
authors.lastname: Hofling-Lima
mesh_terms: D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000592:standards*; D004339:Drug Compounding; D004340:Drug Contamination; D004356:Drug Storage; D006801:Humans; D009465:Neuromuscular Agents / Q000008:administration & dosage / Q000592:standards*; D012034:Refrigeration; D013997:Time Factors
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A