FDA Changes Label on Doripenem to Reflect Ventilator Risks

Megan Brooks


March 06, 2014

The US Food and Drug Administration (FDA) has approved label changes for the antibacterial drug doripenem (Doribax, Johnson & Johnson) to warn of an increased risk for death in patients with ventilator-associated pneumonia.

In this patient population, doripenem "carries an increased risk of death and lower clinical cure rates" compared with use of imipenem and cilastatin for injection (Primaxin, Merck), the agency said in a safety announcement posted today on its Web site.

The FDA notes that doripenem is not approved to treat any type of pneumonia, and the revised label also includes a new warning about this unapproved use.

"Health care professionals should consider whether the benefits of Doribax treatment are likely to exceed its potential risks in patients who develop pneumonia while on ventilators," the FDA said.

"Doripenem is still considered safe and effective for its FDA-approved indications — treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections, including kidney infections called pyelonephritis," the FDA notes.

The label change stems from an analysis of data from a 3-year clinical trial of doripenem in ventilator-associated pneumonia that was halted early due to these safety concerns, the FDA said.

As reported by Medscape Medical News , in the trial, patients with ventilator-associated bacterial pneumonia received either a 7-day course of doripenem or a 10-day course of imipenem and cilastatin.

In the intent-to-treat population, the 28-day all-cause mortality was higher in the doripenem arm (23.0%) than in the imipenem and cilastatin arm (16.7%). Clinical cure rates were also lower in the doripenem arm.


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