The US Food and Drug Administration has finally concluded that the antibiotic Maxipime (cefepime) is not associated with a higher risk of death.

The US regulator was forced to announce it was reviewing safety data of Bristol-Myers Squibb’s and Elan’s drug in November 2007 after publication of a study suggesting increased death rates in patients taking the drug compared to patients treated with similar drugs.

Expectations were that the review would take about four months but there were delays in receiving all the data and a year ago the agency had still not reached a definitive conclusion.

The FDA has now concluded that the “data do not indicate a higher rate of death in cefepime-treated patient. Cefepime remains an appropriate therapy for its approved indications”.

The FDA will continue to review the safety of the drug, and the agency and BMS will use hospital drug use data to conduct separate analyses of death potentially associated with Maxipime. The results of these are expected to be reported in a year.