title: Complications of injectable testosterone undecanoate in routine clinical practice.
abstract: OBJECTIVE
  Injectable testosterone undecanoate (TU) was marketed within the last decade, but its complications in routine clinical practice are not well defined.
  
  
  METHODS
  Prospective observational study of consecutive TU injections in an Andrology Clinic to estimate the incidence of i) immediate cough/syncope due to pulmonary oil microembolisation (POME), ii) post-injection haematoma and iii) the prevalence of secondary polycythaemia.
  
  
  RESULTS
  In 3022 injections given to 347 patients over 3.5 years, POME was observed after 56 injections (66% mild, 19% severe; 40% with onset before injection completed) in 43 patients. The incidence of 19 (95% CI 14-24) per 1000 injections did not differ between three experienced nurse injectors, but recurrences were more frequent than by chance. No post-injection haematoma was reported including after 269 injections to men taking antiplatelet, anticoagulant or both drugs (upper 95% confidence limit 1%) with 56 not withholding drugs prior to TU administration (upper 95% confidence limit 5.4%). Mean haematocrit was 0.44±0.04 (s.d.) with 25 (7%) >0.50, 14 (4%) >0.52 and 3 (1%) >0.54.
  
  
  CONCLUSIONS
  TU injections produce a low incidence of POME with injections by experienced nurses, but recurrence is more frequent than by chance. Post-injection haematoma was not observed even among men using anticoagulant and/or antiplatelet drugs, and polycythaemia was a minor problem rarely requiring treatment other than optimising inter-injection interval.
authors: Andrology DepartmentANZAC Research Institute, Concord Hospital, University of Sydney, Sydney, New South Wales 2139, Australia.
authors: T
authors: T
authors: Middleton
authors: Andrology DepartmentANZAC Research Institute, Concord Hospital, University of Sydney, Sydney, New South Wales 2139, Australia.
authors: L
authors: L
authors: Turner
authors: Andrology DepartmentANZAC Research Institute, Concord Hospital, University of Sydney, Sydney, New South Wales 2139, Australia.
authors: C
authors: C
authors: Fennell
authors: Andrology DepartmentANZAC Research Institute, Concord Hospital, University of Sydney, Sydney, New South Wales 2139, Australia.
authors: S
authors: S
authors: Savkovic
authors: Andrology DepartmentANZAC Research Institute, Concord Hospital, University of Sydney, Sydney, New South Wales 2139, Australia.
authors: V
authors: V
authors: Jayadev
authors: Andrology DepartmentANZAC Research Institute, Concord Hospital, University of Sydney, Sydney, New South Wales 2139, Australia.
authors: A J
authors: AJ
authors: Conway
authors: Andrology DepartmentANZAC Research Institute, Concord Hospital, University of Sydney, Sydney, New South Wales 2139, Australia djh@anzac.edu.au.
authors: D J
authors: DJ
authors: Handelsman
mesh_terms: D000328:Adult; D000368:Aged; D003371:Cough / Q000139:chemically induced / Q000453:epidemiology; D005260:Female; D006406:Hematoma / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D007275:Injections, Intravenous / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011086:Polycythemia / Q000139:chemically induced / Q000453:epidemiology; D015995:Prevalence; D011446:Prospective Studies; D012008:Recurrence; D013575:Syncope / Q000139:chemically induced / Q000453:epidemiology; D013739:Testosterone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood; D055815:Young Adult
chemical_list: D013739:Testosterone; C010792:testosterone undecanoate