The agency expects to take up to four months to review data showing Maxipime, which is used to treat a variety of infections, was linked to a higher risk of death than antibiotics in the same class in an article published last May in The Lancet.

Maxipime, which is also known as Cefepime, is made by Bristol-Myers Squibb and marketed by Elan.

“FDA is working with the manufacturer of cefepime, Bristol-Myers Squibb, to further evaluate the finding of increased mortality in patients who received cefepime. It will take about four months to complete this evaluation at which time FDA will communicate the conclusions and any resulting recommendations to the public,” the agency wrote on its web site this morning.