PMID- 27621644
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160913
LR  - 20200929
IS  - 1176-6336 (Print)
IS  - 1178-203X (Electronic)
IS  - 1176-6336 (Linking)
VI  - 12
DP  - 2016
TI  - Safety of long-term use of linezolid: results of an open-label study.
PG  - 1347-54
LID - 10.2147/TCRM.S109444 [doi]
AB  - OBJECTIVE: The objective of this study was to assess the long-term safety of 
      linezolid in patients with chronic infections requiring treatment for >/=6 weeks. 
      Enhanced monitoring for optic neuropathy was included to characterize the early 
      development of this side effect and to identify ophthalmologic tests that might 
      be valuable in early detection of this event. METHODS: This was a multicenter, 
      open-label, pilot study of patients aged >/=18 years on long-term linezolid 
      therapy. Matched control patients were included for baseline assessment 
      comparison. Patients were assessed at study entry, monthly while on treatment, at 
      the end of treatment, and 30 days following the last dose. Aggregate ocular 
      safety data were reviewed. Response to treatment was reported. RESULTS: The study 
      was terminated owing to slow enrollment. Twenty-four patients received linezolid; 
      nine patients were included as matched controls. Linezolid was prescribed for a 
      median of 80.5 days (range, 50-254 days). In patients with a reported clinical 
      outcome, the majority were considered improved or cured. Common treatment-related 
      adverse events (AEs) included anemia, peripheral neuropathy, polyneuropathy, 
      vomiting, and asthenia, and were consistent with the known safety profile. Most 
      AEs resolved or stabilized with discontinuation of treatment. Results of 
      ophthalmologic tests in the one case adjudicated as probable linezolid-associated 
      optic neuropathy revealed abnormal color vision, characteristic changes in the 
      optic disk, and central scotomas in each eye. CONCLUSION: In our small 
      population, linezolid was generally well tolerated and AEs were consistent with 
      the known safety profile. Extensive ophthalmologic testing of all 24 
      linezolid-treated patients identified one case adjudicated as probable, 
      linezolid-associated optic neuropathy.
FAU - Vazquez, Jose A
AU  - Vazquez JA
AD  - Section of Infectious Diseases, Medical College of Georgia, Georgia Regents 
      University, Augusta, GA, USA.
FAU - Arnold, Anthony C
AU  - Arnold AC
AD  - UCLA Department of Ophthalmology, Jules Stein Eye Institute, Los Angeles, CA, 
      USA.
FAU - Swanson, Robert N
AU  - Swanson RN
AD  - Clinical Research, Global Innovative Pharmaceutical, Pfizer Inc., New York, NY, 
      USA.
FAU - Biswas, Pinaki
AU  - Biswas P
AD  - Clinical Research, Global Innovative Pharmaceutical, Pfizer Inc., New York, NY, 
      USA.
FAU - Bassetti, Matteo
AU  - Bassetti M
AD  - Infectious Diseases Division, Santa Maria della Misericordia University Hospital, 
      Udine, Italy.
LA  - eng
PT  - Journal Article
DEP - 20160901
PL  - New Zealand
TA  - Ther Clin Risk Manag
JT  - Therapeutics and clinical risk management
JID - 101253281
PMC - PMC5012852
OTO - NOTNLM
OT  - linezolid
OT  - optic nerve diseases
OT  - oxazolidinones
OT  - peripheral nervous system diseases
OT  - safety
EDAT- 2016/09/14 06:00
MHDA- 2016/09/14 06:01
PMCR- 2016/09/01
CRDT- 2016/09/14 06:00
PHST- 2016/09/14 06:00 [entrez]
PHST- 2016/09/14 06:00 [pubmed]
PHST- 2016/09/14 06:01 [medline]
PHST- 2016/09/01 00:00 [pmc-release]
AID - tcrm-12-1347 [pii]
AID - 10.2147/TCRM.S109444 [doi]
PST - epublish
SO  - Ther Clin Risk Manag. 2016 Sep 1;12:1347-54. doi: 10.2147/TCRM.S109444. 
      eCollection 2016.