Maxipime May Be Linked to Increased Risk for Death

Yael Waknine

Disclosures

November 15, 2007

November 15, 2007 — Cefepime HCl injection (Maxipime, Bristol-Myers Squibb Co) may be linked to an increased risk for death, the US Food and Drug Administration (FDA) warned healthcare professionals yesterday in an early communication.

The warning was based on data from a systematic review and meta-analysis published in the May 2007 issue of The Lancet Infectious Diseases showing that use of cefepime was linked to an increased risk for all-cause mortality compared with other beta lactam antibiotics (risk ratio [RR], 1.26; 95% confidence interval [CI], 1.08 – 1.49), particularly in patients with febrile neutropenia (RR, 1.42; 95% CI, 1.09 – 1.84).

These findings have prompted an FDA review of new safety data and a request for additional data to further evaluate this risk, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program.

At the end of the evaluation, which is expected to take 4 months, the FDA will communicate its conclusions and any resulting recommendations. Until that time, healthcare providers are advised to consider the risks and benefits of cefepime therapy as described in the safety labeling and the meta-analysis.

Cefepime is indicated for the treatment of infections caused by susceptible gram-positive and gram-negative microorganisms, including Enterobacter, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, and Viridans group streptococci.

Indications include empiric therapy for febrile neutropenic patients, moderate to severe pneumonia, uncomplicated and complicated urinary tract infections, uncomplicated skin/skin structure infections, and complicated intra-abdominal infections.

Adverse events related to cefepime therapy should be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

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