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.”
Do I have a Doribax Lawsuit?
The Schmidt Firm, PLLC is currently accepting Doribax induced injury cases in all 50 states. If you or somebody you know has been injured by Doribax, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.