FDA Drug Safety Communication

FDA has performed a safety review about the potential increased mortality in patients treated with cefepime. FDA performed meta-analyses and found no statistically significant increase in mortality in cefepime-treated patients vs comparator-treated patients. Based on these results, FDA has determined that cefepime remains an appropriate therapy for its approved indications.

This information reflects FDA's current analysis of data available to FDA concerning cefepime. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging safety issue. Nor does it mean that FDA is advising healthcare professionals to discontinue prescribing this product. FDA intends to update this communication when additional information or analyses become available.

View the full FDA Drug Safety Communication on FDA.gov