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Doribax May Increase Death Risk for Pneumonia Patients

Doribax May Increase Death Risk for Pneumonia Patients

March 7, 2014 — Doribax (doripenem) has been linked to a 23% risk of death and a lower cure-rate when compared to Primaxin (imipenem and cilastatin) for the treatment of ventilator-associated pneumonia.

In November 2012, Critical Care published results of a clinical trial comparing Doribax and Primaxin that was halted prematurely. Patients with ventilator-associated pneumonia were randomized to receive either a 10-day treatment of Primaxin or a 7-day treatment of Doribax.

After 28 days, death occurred in 23% of Doribax patients versus 16.7% of Primaxin patients. The overall cure-rate for Dorixbax was 45.6% versus 56.8% of Primaxin patients. For patients infected with the most common type of ventilator-associated pneumonia, the cure-rate was even lower — 41.2% for Doribax versus 60% for patients on Primaxin.

Doribax is a broad-spectrum antibiotic drug manufactured by Japan-based Shionigo Co. and distributed by Johnson & Johnson. It is approved to treat intra-abdominal infections, complex urinary tract infections, and kidney infections (pyelonephritis). Doctors prescribe it “off-label” to treat pneumonia.

The U.S. Food and Drug Administration (FDA) has published a Safety Communication and updated the warning label on Doribax to reflect this risk information. However, it is not the first warning related to the prematurely-halted study. More than two years ago, the FDA published the following warning:

“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.”

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