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Antimicrobial Agents and Chemotherapy, June 2003, p. 1824-1831, Vol. 47, No. 6
0066-4804/03/$08.00+0     DOI: 10.1128/AAC.47.6.1824-1831.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

Worldwide Assessment of Linezolid's Clinical Safety and Tolerability: Comparator-Controlled Phase III Studies

Ethan Rubinstein,1* Raul Isturiz,2 Harold C. Standiford,3 Leon G. Smith,4 Thomas H. Oliphant,5 Sue Cammarata,5 Barry Hafkin,6 Vu Le,5 and Jack Remington7

The Chaim Sheba Medical Center, Sackler School of Medicine, Tel Aviv University, Tel-Hashomer, Israel,1 Centro Medico de Caracas, Caracas, Venezuela,2 Veterans Affairs Medical Center and University of Maryland School of Medicine, Baltimore, Maryland,3 Saint Michael's Medical Center, Newark, New Jersey,4 Pharmacia Corp., Peapack, New Jersey,5 Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut,6 Stanford University School of Medicine, Stanford, California7

Received 1 August 2002/ Returned for modification 18 September 2002/ Accepted 7 March 2003

Linezolid, an oxazolidinone antibiotic, has 100% oral bioavailability and favorable activities against gram-positive pathogens including multidrug-resistant staphylococci, enterococci, and pneumococci. Safety assessments were conducted for 2,046 linezolid-treated patients and 2,001 comparator drug-treated patients from seven controlled clinical trials comparing the activities of linezolid and comparator drugs against nosocomial and community-acquired pneumonia, skin and skin structure infections, and methicillin-resistant staphylococcal infections. Drug-related adverse events were primarily transient. The most frequent (>=2%) adverse events caused by linezolid and the comparator drugs were diarrhea (4.3 and 3.2%, respectively; P = 0.074), nausea (3.4 and 2.3%, respectively; P = 0.036), and headache (2.2 and 1.3%, respectively; P = 0.047). Treatment discontinuations due to drug-related events (2.4 and 1.9%, respectively), serious adverse events (11.4 and 10.6%, respectively), and deaths (4.8 and 4.9%, respectively) were similar. No clinically significant drug-related hematologic events were reported, and laboratory safety data were comparable. In the first 6 months of postmarketing surveillance, hematologic abnormalities were reported in 0.1% of linezolid-treated patients, but no irreversible blood dyscrasias were documented. The risk for transient, reversible hematologic effects from treatment with linezolid should be considered together with the clinical benefits associated with its use.

* Corresponding author. Mailing address: Infectious Diseases Unit, The Chaim Sheba Medical Center, Sackler School of Medicine, Tel-Hashomer, 52621, Israel. Phone: 972 35 30 35 00. Fax: 972 35 30 35 01. E-mail: erubins{at}yahoo.com.

Antimicrobial Agents and Chemotherapy, June 2003, p. 1824-1831, Vol. 47, No. 6
0066-4804/03/$08.00+0     DOI: 10.1128/AAC.47.6.1824-1831.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.



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