Objective: To investigate the safety of norvancomycin, and provide basis for its rational use in clinical practice.
Methods: We documented all adverse events occurred in inpatients who receive intravenous infusion of norvancomycin, then we evaluated the relationship between adverse events and norvancomycin and calculated the rates of adverse reaction.
Results: 1031 patients were enrolled in this study from March 2002 to June 2003 and 965 of them could be evaluated. 80 adverse reactions occurred in 965 patients who received norvancomycin, giving a total adverse reaction rate of 8.29%. The systemic adverse reactions included renal impairment (4.04%), hepatic impairment (2.38%) and allergic reaction (1.76%). 15 patients discontinued the treatment because of the adverse reaction. The rates were higher in patients who use other antimicrobial agents concomitantly or whose age >/= 60 years. The rates of renal impairment were higher in those with age >/= 60 years, and the rates of hepatic impairment were higher in whose received this agent longer than 14 days. These factors were independent risk factors (P < 0.05).
Conclusions: The overall adverse reaction rate of norvancomycin was low. A few patients experienced drug-related reaction, most of these adverse reactions were mild and tolerable. The adverse reactions tended to occur in older patients, those who use other antibiotic concomitantly or those who receive this agent longer than 14 days.