The antibiotic drug Doribax (doripenem) has been associated with a higher risk of death and a lower cure-rate when it is used instead of Primaxin to treat ventilator-associated pneumonia. Doribax is not approved to treat any type of pneumonia.
What You Can Do & How a Doribax Lawsuit Can Help
The Schmidt Firm, PLLC is currently accepting Doribax induced injury cases in all 50 states. If you or somebody you know was 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 us toll-free 24 hours a day at (866) 920-0753.
Clinical Trial Links Doribax and Higher Risk of Death
Critical Care published preliminary results of a three-year clinical trial that was stopped prematurely in 2011. Researchers randomly assigned 274 patient with ventilator-associated pneumonia to receive either Doribax or Primaxin.
Conclusions of the study:
- Doribax had a higher risk of death: After 28 days, 23% of Doribax patients died, compared to 16.7% of Primaxin patients.
- Doribax had a lower cure-rate: Overall, 45.6% of Doribax patients were cured, compared to 56.8% of Primaxin patients.
- Cure-rates were even worse for the most common type of ventilator-associated pneumonia. When researchers limited results to infections with Pseudomonas aeruginosa, 41.2% of Doribex patients were cured, compared to 60% of Primaxin patients.
FDA Warns Against Using Doribax for Ventilator-Associated Pneumonia
The U.S. Food and Drug Administration (FDA) has issued two warnings about the risks associated with Doribax and ventilator-associated pneumonia. The first Safety Alert was published on January 5, 2012, soon after the clinical trial was stopped early. The FDA warned that Doribax is not approved for pneumonia or at doses above 500-mg every 8 hours.
On March 6, 2014, the FDA concluded their investigation with another Safety Communication, warning:
“Doribax (doripenem), an antibacterial drug that has been used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to use of [Primaxin] imipenem and cilastatin for injection.”
Doribax and Ventilator-Associated Pneumonia
Doribax is not approved for pneumonia. This use is “off-label,” and it has not been evaluated by the FDA. Ventilator-associated pneumonia is one of the most serious hospital-acquired infections, estimated to affect 28% of patients who need mechanical ventilation.
Bacteria is introduced into the patient’s lungs through the tube that is inserted in their mouth, nose, or a hole in their throat. Because these patients are often critically ill, the infection is fatal in 27-76% of cases — depending on the clinic the type of bacteria.
Symptoms of Ventilator-Associated Pneumonia
- Low body temperature
- High number of white blood cells (leukocytosis)
- new or progressive infiltrate on chest radiograph
- Fluid or discharge from lungs (secretions containing pus)
- Fast heartbeat
Do I have a Doribax Lawsuit?
The Schmidt Firm, PLLC is currently accepting Doribax injury cases in all 50 states. If you or somebody you know was 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 us toll-free 24 hours a day at (866) 920-0753.
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