June 17, 2009
Cefepime safety review updateThe FDA has notified healthcare professionals that it has finished its analysis of a possible higher risk of death with cefepime (Maxipime, from Elan Pharmaceuticals), a cephalosporin antibiotic, and has determined that the data do not indicate a higher rate of death in cefepime-treated patients. This safety review followed the publication of a study suggesting a higher death rate in patients treated with cefepime compared to other similar drugs. The FDA reviewed the study data and conducted further analyses based on additional data, including data submitted by Bristol-Myers Squibb. The FDA and Bristol-Myers Squibb will continue to review the safety of cefepime and will conduct separate analyses of death potentially associated with cefepime, using hospital drug use data.
Cefepime remains an appropriate therapy for its approved indications. It is indicated for the treatment of susceptible infections, including moderate-to-severe pneumonia, uncomplicated skin and skin structure infections, complicated and uncomplicated urinary tract infections (UTIs) including pyelonephritis, complicated intraabdominal in adults (w. metronidazole) as well as for empiric therapy in febrile neutropenia.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm167427.htm.