FDA Approves Doribax Label Changes
According to Medscape, the U.S. Food and Drug Administration (FDA) has decided to approve a series of label changes for the antibacterial drug Doribax (dorpenem)
Doribax is an antibacterial drug prescribed to patients with bacterial infections of the internal abdomen as well as significant urinary tract infections (UTI); however, recent data suggests that the drug can result in an increased risk of death in patients who are administered the drug while they have ventilator-associated pneumonia.
The issue was initally discovered during a 3-year clinical trial in which researchers were investigating the efficacy of Doribax as a treatment for ventilator-associated bacterial pneumonia.
During the trial, patients received either a 7-day course of Doribax or a 10-day course of imipenem and cilastatin.
The study had to be terminated after it was determined that the mortality rate was significantly higher among patients treated with doripenem than those treated with impenem and cilastatin – 23 percent to 16.7 percent respectively. Cure rates were also lower in patients treated with doripenem.
Doribax is not FDA approved to treat ventilator-associated pneumonia and the new labels will also explicitly state this fact.
Side Effects of Doribax
The following adverse events have been reported to the FDA in connection to Doribax:
- Respiratory failure
- Renal failure
- Multi-organ failure