Indications of a new antibiotic in clinical practice: results of the tigecycline initial use registry

ABSTRACT

Tigecycline is the first of a new class of antibiotics named glycylcyclines and it was approved for the treatment of complicated intra-abdominal infections and complicated skin and skin structure infections. Notwithstanding this, tigecycline's pharmacological and microbiological profile which includes multidrug-resistant pathogens encourages physicians' use of the drug in other infections. We analyzed, during the first months after its launch, the tigecycline prescriptions for 113 patients in 12 institutions. Twenty-five patients (22 percent) received tigecycline for approved indications, and 88 (78 percent) for "off label" indications (56 percent with scientific support and 22 percent with limited or without any scientific support). The most frequent "off label" use was ventilator associated pneumonia (VAP) (63 patients). The etiology of infections was established in 105 patients (93 percent). MDR-Acinetobacter spp. was the microorganism most frequently isolated (50 percent of the cases). Overall, attending physicians reported clinical success in 86 of the 113 patients (76 percent). Our study shows that the "off label" use of tigecycline is frequent, especially in VAP. due to MDR-Acinetobacter spp., where the therapeutic options are limited (eg colistin). Physicians must evaluate the benefits/risks of using this antibiotic for indications that lack rigorous scientific support.