FDA Recommends Caution Over Maxipime Risk

The FDA warned healthcare professionals to be cautious when prescribing Bristol-Myers Squibb’s (BMS) broad-spectrum B-lactam antibiotic Maxipime after a medical journal article found a higher level of mortality due to all causes in patients receiving it.

The agency said in a MedWatch statement it is reviewing new safety data and has requested additional information to evaluate the risk of death in patients taking the drug. In May, the British medical journal The Lancet Infectious Diseases found a higher level of mortality due to all causes in patients treated with Maxipime (cefepime HCl) compared with those using other B-lactam antibiotics.

Until the agency finishes its evaluation, healthcare professionals who are considering prescribing Maxipime should be aware of the risks and benefits in the product’s prescribing information and the new information from the medical journal’s meta-analysis, the FDA said. Maxipime is distributed by Elan Biopharmaceuticals.

“BMS has conducted a detailed review of cefepime data from BMS-sponsored trials as well as data from postmarketing safety databases and a review of the literature. The review of the totality of data indicates that the safety profile of cefepime is unchanged from that previously described in regulatory submissions,” Tony Plohoros, a spokesman for BMS, said.

The MedWatch statement can be found at www.fda.gov/cder/drug/early_comm/cefepime.htm