United States FDA Drug Safety Communication: Doripenem - risk when used to treat pneumonia on ventilated patients

The FDA has concluded that doripenem carries an increased risk of death and lower clinical cure rates vs. the use of imipenem and cilastatin. The risks and benefits of treatment in this cohort should be carefully considered before prescribing. The drug’s label will be updated.

Although it is not licensed for pneumonia in the United States, the licensed indications in the UK include nosocomial pneumonia (including ventilator–associated pneumonia).

 

Note:

Doripenem is being withdrawn from the European market and the UK product withdrawal will be completed by the end of March 2014. The company has advised that the rights for doripenem (Doribax™) have been returned to its licensing partner who will not be marketing it in the EU.