Ongoing Safety Review of Maxipime

Posted on April 29, 2008

FDA has notified healthcare professionals about a recent study that raises the possibility of an increased risk of death among patients taking cefepime, which is marketed as Maxipime. The study, reported in the journal, The Lancet Infectious Diseases, is a meta-analysis that shows a significant difference in mortality from all causes when Maxipime is compared with other beta-lactam antibiotics.

This notification is part of FDA's commitment to inform people about safety evaluations of drugs in their early stages, in some cases before new findings are fully confirmed and before their clinical significance is established.

In this case, FDA is working with the manufacturer of Maxipime to further evaluate the study's findings, and has requested additional data on the mortality risk associated with this drug. As soon as this evaluation is finished, FDA will make the findings known.

In the meantime, prescribers who are considering using Maxipime should be aware of the risks and benefits described in the prescribing information, and the new information from this meta-analysis.

Additional Information:

FDA MedWatch Safety Alert. Cefepime (marketed as Maxipime). November 14, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Cefepime