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Ongoing Safety review of Cefepime By US FDA


November 14, 2007, the US Food and drug Administration, the American's equivalent to the Saudi Food and Drug Authority (SFDA), announced ongoing review of safety information of cefepime marketed as Maxipime. Cefepime 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 β–lactams .

Publications in a recent issue of The Lancet Infectious Diseases have raised the question about the association of increased mortality with the use of Cefepime. US FDA has reviewed some safety data and requested additional data to further evaluate the risk of death in patients treated with cefepime.

An article in the May 3, 2007, issue of The Lancet Infectious Diseases describe increased rates of all-cause mortality in patients treated with cefepime compared to other β–lactams.

US 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 US FDA will communicate the conclusions and any resulting recommendations to the public.

Action that Healthcare Professional should follow:

  • Upon initial review, it is unclear how these data on mortality should be interpreted. Therefore 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.
  • Posting this information does not mean that US FDA has concluded there is a causal relationship between the drug products and the emerging safety issue

Report Adverse Drug Reactions to the Saudi FDA:

Public and health professionals are encouraged to report adverse drug reactions to the National Pharmacovigilance Center on the Internet at: