FDA is Continuing to Review Safety Concerns About Maxipime (cefepime) Death Risk

On Wednesday, the FDA provided an update to an early communication issued last November about concerns that an injectable antibiotic known as Maxipime (cefepime), may increase the risk of death when compared to similar drugs. Although the FDA originally indicated that the preliminary review would take about four months, they have indicated that the review of safety data is still ongoing.

Maxipime is an antibiotic used for treatment of pneumonia and other serious infections. Concerns about the safety of the drug first surfaced in 2007, when a meta-analysis published in the medical journal Lancet Infectious Diseases, suggested that individuals treated with the antibiotic may face an increased risk of death.

“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,” according to the agency. “As a result, FDA has not reached a definitive conclusion as to whether or not the increased mortality seen with cefeprime compared to other beta-lacctam antibiotics observed in the meta-analysis is due to cefepime.”

The FDA did not give any new indication about the amount of time expected to complete the evaluation or whether any regulatory actions will be taken.

An early communication does not mean that the agency has found a connection between the use of Maxipime and the identified safety concern. The FDA has urged healthcare providers and patients to report any Maxipime side effects to their MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm or toll free at 1 (800) 332-1088.

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