Doribax Side Effects May Increase Death Risk for Pneumonia Patients: FDA

Federal drug regulators are warning that the Johnson & Johnson antibiotic Doribax should not be used to treat patients who develop pneumonia while on ventilators, due to an increased risk of death.  

On March 6, the FDA issued a drug safety communication announcing changes to the warning label and prescribing information for Doribax. The agency says that the antibacterial medication carries an increased risk of death for patients with pneumonia on ventilators, and has a lower cure rate for those patients compared to Merck’s Primaxin.

The label update warns that the FDA has never approved Doribax for treatment of pneumonia, and said it still considers the drug safe for its approved uses.

Doribax (doripenem) is a broad spectrum injectable antibiotic developed by Shionogi Co. in Japan and distributed outside of Japan by Johnson & Johnson. It was first approved by the FDA in October 2007, for treatment of intra-abdominal infections, urinary tract infections and a form of kidney infection called pyelonephritis. However, doctors sometimes use the antibiotic “off-label” to treat other bacterial infections.

While it is illegal for companies to promote drugs for uses not approved by the FDA, doctors may prescribe any approved medications for whatever purpose they see fit.

The FDA came to the decision to change the warning label after an analysis of data from a three-year clinical trial, which was halted early when test subjects with ventilator-associated bacterial pneumonia were seen to have a 23% higher death rate when given Doribax treatment than those given Primaxin.

The problems may be linked to the dosage size needed to treat ventilator-acquired pneumonia. At the time the clinical study was ended, the FDA and Johnson & Johnson reminded doctors that Doribax is not approved for doses greater than 500 mg every eight hours.

Another study, published in September in the American Society for Microbiology, linked Doribax to a number of cases of liver dysfunction. The FDA warning does not appear to cover or reference that study.