Off-label use of antibiotics in hospitalized patients: focus on tigecycline. J Antimicrob Chemother 64:1344 –1346. http://dx.doi.org /10.1093/jac/dkp342

Tigecycline is the first of a new class of antibiotics named glycylcyclines and is active in vitro against a variety of Gram-positive and Gram-negative organisms, including vancomycin-resistant enterococci, methicillin-resistant Staphylococcus aureus, extended-spectrum b-lactamase-producing Enterobacteriaceae and multidrug-resistant (MDR) Acinetobacter spp.1 It has been approved by the US FDA for the treatment of complicated intra-abdominal infections (cIAIs), complicated skin and skin structure infections (cSSSIs)1 and community-acquired bacterial pneumonia (CABP).2 Notwithstanding these indications, tigecycline’s pharmaco-logical and microbiological profiles encourage physicians ’ use of the drug for off-label indications.3,4 The definition of off-label use is not limited to prescribing an antibiotic for an indication that is not approved by regulatory authorities. The off-label use of a medication may include other parameters such as age, severity of illness, dose and route of administration and drug combinations, among others.5 Taking this into consideration, we have evaluated some characteristics of a group of patients treated with tigecycline for the approved indications (cSSSIs, cIAIs and CABP) and com-pared them with the patients included in the randomized clinical trials (RCTs) developed by the pharmaceutical company for each indication