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.”

Did You Know?

Millions of Philips CPAP Machines Recalled

Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.

Learn More

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.

Related Page: Maxipime Antibiotic Lawsuits


  • Maxipime Lawsuits — AboutLawsuits.comMay 15, 2008 at 2:38 am

    [...] May 14, 2008, an update was issued by the FDA, since they had not completed their review of the Maxipime side effects within four months, as they had originally anticipated. They indicated that their review is ongoing [...]

"*" indicates required fields

Share Your Comments

I authorize the above comments be posted on this page*

Have Your Comments Reviewed by a Lawyer

Provide additional contact information if you want an attorney to review your comments and contact you about a potential case. This information will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Onewheel "Nosedive" Lawsuit Filed Days Before Manufacturer Recalled Electric Skateboards (Posted today)

A OneWheel nosedive lawsuit claims the battery-operated scooter is defectively designed, causing riders to suffer serious injuries when the device suddenly stops and pitches forward.

Problems with Philips CPAP Machines Reported 11 Years Before Recall Issued By Manufacturer
Problems with Philips CPAP Machines Reported 11 Years Before Recall Issued By Manufacturer (Posted 4 days ago)

A ProPublica report reveals that Philips officials hid thousands of reports of problems with sound abatement foam used in millions of CPAP machines, failing to recall the devices for more than a decade after receiving the first complaints.