Six Months After It Announced Start Of This Investigation, FDA Gives An Update On Status Of Maxipime Safety Review

(Posted by Tom Lamb at DrugInjuryWatch.com)

In mid-November 2007 the FDA announced the start of its investigation into the safety of Maxipime (cefepime), and said their safety evaluation should take about four months to complete. 

The focus of this FDA investigation was the possible increased risk of death associated with Maxipime, which is an injectable antibiotic that is manufactured by Bristol-Myers Squibb Co. (BMY) and marketed in the U.S. by Elan Corp. PLC (ELN).

In mid-May 2008 the FDA let us know that their Maxipime safety evaluation was taking longer than initially anticipated.  A May 14 MedWatch email from the FDA provided a link for Update of Safety Review: Follow-up to the November 14, 2007, Communication about the Ongoing Safety Review of Cefepime (marketed as Maxipime), which purportedly "reflects FDA’s current analysis of available data concerning this drug."

From this May 2008 Maxipime Update, we learn where the FDA is in their investigation:

FDA is continuing to review safety data for the drug [Maxipime].  There are a large number of studies to be reviewed and some, but not all, of the requested study data have been received by the FDA.  As a result, FDA has not reached a definitive conclusion as to whether or not the increased mortality seen with cefepime compared to other β-lactam antibiotics observed in the meta-analysis is due to cefepime.

Maxipime is a broad-spectrum antibiotic approved by the FDA in 1996 for the treatment of infections due to susceptible strains of microorganisms.

We will continue to monitor the FDA’s progress with this ongoing safety evaluation of Maxipime.