When the antibiotic drug Doribax (doripenem) is used “off-label” at high doses to treat ventilator-associated pneumonia, patients have a higher risk of death and a lower overall cure-rate. In March 2014, the FDA approved label updates to reflect this risk information.
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What is Doribax?
Doribax (doripenem) is a broad-spectrum antibiotic that was developed by Shionigi Co. It was approved in the United States in October 2007 and is sold by Johnson & Johnson. Doribax is approved to treat: complicated intra-abdominal infections and urinary tract infections, and certain kidney infections (pyelonephritis).
Clinical Trial of Doribax Halted Early Due to Higher Risk of Death
In November 2012, Critical Care published preliminary results of a study that ran from 2008 until 2011, when it was halted prematurely. Researchers found that patients with ventilator-associated pneumonia who were treated with Doribax were significantly more likely to die and less likely to be cured than patients on Primaxin (imipenem / cilastatin).
Results of the study after 28 days of treatment:
- Death occurred in 23% of Doribax patients, vs. 16.7% of patients on Primaxin.
- The overall cure-rate was 45.6% of Doribax patients, vs. 56.8% of patients on Primaxin.
- For patients infected with Pseudomonas aeruginosa, the most common cause of ventilator-associated pneumonia, cure-rate was 41.2% of Doribax patients, vs. 60% of patients on Primaxin.
FDA Safety Warnings for Doribax Risks
The U.S. Food and Drug Administration (FDA) published their first Safety Alert for Doribax in January 2012, shortly after the clinical trial was halted. They warned that Doribax is not approved to treat any type of pneumonia.
In addition, Doribax is not approved at doses higher than 500-mg every eight hours. During the study, doctors administered 1,000-mg doses of Doribax as 4-hour infusions every eight hours.
After reviewing the matter for two years, the FDA published another Drug Safety Communication in March 2014. The FDA concluded:
“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 imipenem and cilastatin for injection (marketed in the U.S. under the name Primaxin).”
Ventilator Associated Pneumonia
Ventilator-associated pneumonia is a lung infection that is acquired in a hospital setting among critically-ill patients on mechanical ventilation. The bacteria is introduced into the lungs through the ventilator tube, which is placed through the mouth, nose, or a hole in the throat. It is estimated to infect 28% of patients on a ventilator, and is one of the leading causes of death — especially among patients infected with Pseudomonas or Acinetobacter microorganisms.
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