According to the FDA the antibacterial drug Doribax, that has been used to treat patients who develop pneumonia on ventilators, carries an increased risk of death and has a lower clinical cure rate by injection compared a similar drug known as Primaxin.
What is Doribax?
Doribax is an antibiotic that fights serious infections caused by bacteria. It is used to treat severe infections of the stomach, bladder, or kidneys.
The medicine is administered by injection and must be given slowly through an IV infusion and can take up to an hour to complete.
Doribax is given for 5 days over a two week period, however, this depends on the condition being treated. The option to switch to the oral antibiotic is available only after receiving the Doribax injection after the first few days.
Possible serious side effects may include:
- Diarrhea that is bloody
- Trouble breathing
- Pale skin
- Fever, sore throat, and headache with severe blistering, peeling red skin rash
Less serious side effects may include:
- Pain or swelling at the site of injection
- Mild nausea
- White patches or sores inside the mouth
- Vaginal itching or discharge
You should not take Doribax if you are allergic to doripenem or imipenem.
FDA Approves Label Change For Doribax
Based on the analysis of data gathered from a three-year clinical trial the FDA concluded that Doribax is not approved to treat any kind of pneumonia.
The three-year clinical trial was stopped in 2011 because of the FDA’s safety concerns which in turn lead to the revision of the label, which now includes that the drug should not be used to treat any kind of pneumonia.
However, Doribax is still considered safe and effective for its FDA-approved indications, which are treatment of adults with complicated abdominal infections and complicated urinary tract infections, including kidney infections called pyelonephritis.