Drugs Xagena
An article in of The Lancet Infectious Diseases has raised the question about increased mortality with the use of Cefepime ( Yahav D, Paul M, Fraser A et al. Efficacy and safety of Cefepime: a systematic review and meta-analysis, Lancet Infect Dis 2007; 7: 33848 ).
The FDA ( Food and Drug Administration ) is reviewing some safety data and has requested additional data to further evaluate the risk of death in patients treated with Cefepime.
Cefepime ( Maxipime ) is a broad spectrum cephalosporin antibiotic currently approved for the treatment of a variety of infections due to susceptible strains of microorganisms.
It is a member of the class of antibiotics known as βlactams.
The article in the May 2007 issue of The Lancet Infectious Diseases describes a higher all-cause mortality in patients treated with cefepime compared to other βlactams. Overall, the all-cause mortality was higher with cefepime than other β-lactams ( risk ratio [RR] 1·26 ) and for the subgroup of patients with febrile neutropenia ( RR 1·42 ).
FDA is working with the manufacturer of Cefepime, Bristol-Meyers Squibb, to further evaluate the finding of increased mortality in patients who received Cefepime. It will take about 4 months to complete this evaluation at which time FDA will communicate the conclusions and any resulting recommendations to the public.
Until the evaluation is completed, healthcare providers who are considering the use of Cefepime should be aware of the risks and benefits described in the prescribing information and the new information from this meta-analysis.
Source: FDA, 2007
XagenaMedicine_2007
