title: Nonsurgical treatment of Dupuytren's contracture: 1-year US post-marketing safety data for collagenase clostridium histolyticum.
abstract: BACKGROUND
  Collagenase clostridium histolyticum (CCH) is a Food and Drug Administration-approved treatment for adult patients with Dupuytren's contracture with a palpable cord that has been shown efficacious and safe in clinical trials.
  
  
  METHODS
  This paper summarizes the most common post-marketing clinical adverse event (AE) reports received by the manufacturer of CCH and sponsor of the US Biologics License Application (Auxilium Pharmaceuticals, Malvern, PA, USA) during the first 12 months after drug approval and commercialization in the USA.
  
  
  RESULTS
  Of the 115 AE reports describing 270 AEs voluntarily received from patients or health care providers after approximately 5,400 injections of CCH administered, the most common AEs involved local, nonserious reactions to treatment, including skin tears, peripheral edema, and contusion. There were few serious AEs observed (0.6% reporting rate per 1,000 injections), and two flexor tendon ruptures and one flexor pulley injury were reported.
  
  
  CONCLUSIONS
  Analysis of post-marketing AEs received for CCH in the first year post-approval supports the safety profile reported earlier during clinical development and did not reveal additional clinical risks or concerns about CCH.
authors.affiliation: College of Human Medicine, Michigan State University, Hand Surgery Office, 1414 W. Fair Avenue, Suite 249, Marquette, MI 49855 USA.
authors.forename: C A
authors.initials: CA
authors.lastname: Peimer
authors.forename: C A
authors.initials: CA
authors.lastname: McGoldrick
authors.forename: G J
authors.initials: GJ
authors.lastname: Fiore
keywords: Clinical adverse event; Collagenase clostridium histolyticum; Dupuytren’s contracture