Doribax May Increase Death Risk for Pneumonia Patients

March 7, 2014 — When the antibiotic Doribax (doripenem) is used “off-label” to treat ventilator-associated pneumonia, it has a 23% higher rate of death and lower cure-rates when compared to Primaxin (imipenem and cilastatin).

The U.S. Food and Drug Administration (FDA) has published a Safety Communication and updated the warning information on Doribax to include this risk information. The FDA originally warned about the problem two years ago, in January 2012:

“Healthcare professionals should be aware that Doribax is not approved to treat any type of pneumonia, nor is it approved for doses greater than 500 mg every eight hours.”

Doribax (doripenem) is a broad-spectum antibiotic that was developed by Japan-based pharmaceutical company Shionogi Co. and distributed in the United Stats by Johnson & Johnson. It is still considered safe and effective for FDA-approved indications, including intra-abdominal infections, complex urinary tract infections, and kidney infections (pyelonephritis).

Study Halted After Doribax Linked to 23% Risk of Death

Conclusions were based on a clinical that was stopped prematurely. Results were published in November 2012 in Critical Care. Patients with ventilator-associated bacterial pneumonia were given a 7-day Doribax treatment or a 10-day treatment with Primaxin. After 28 days, death occurred in 23% of Doribax patients, versus 16.7% patients on Primaxin.

In addition, the overall cure-rate for patients on Doribax was lower — 45.6% versus 56.8%. Similarly, cure-rate for the most common ventilator-associated pneumonia was also lower for patients on Doribax — 41.2% versus 60.0%.

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