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  • Title: Safety of intravenous infusion of doripenem.
    Author: Redman R, File TM.
    Journal: Clin Infect Dis; 2009 Aug 15; 49 Suppl 1():S28-35. PubMed ID: 19619019.
    Abstract:
    Carbapenems remain a mainstay for the empirical treatment of serious nosocomial infection. Although the tolerance and safety profile of the carbapenems as a class is favorable, the primary safety concern is the potential for treatment-emergent seizures. In preclinical testing, doripenem, a new carbapenem antibiotic, showed negligible neurotoxic effects. The safety and tolerability of intravenous doripenem was evaluated in 1 phase 2 and in 6 phase 3 clinical trials conducted with patients with nosocomial pneumonia, including ventilator-associated pneumonia; complicated intra-abdominal infection; and complicated urinary tract infection. Safety data were available from 1817 patients who received doripenem and 1325 patients who received 1 of 4 active comparator drugs as part of this development program. Overall, intravenous doripenem was found to be safe and well tolerated, demonstrating a safety profile comparable to that of comparator agents and a limited propensity to induce seizures, including when administered via 1-h or 4-h infusion. j.
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