doripenem warning

Q: FDA has a black box warning for Doripenem about increased mortality rates in which patient population? (select one)

A) Ventilator-associated bacterial pneumonia

B) Dialysis patients with sepsis

Answer: A

Doripenem has excellent clinical efficacy in complicated urinary tract and intra-abdominal infections. It has also shown better in vitro activity against P. aeruginosa than meropenem. Said that the US Food and Drug Administration (FDA) has issued in 2014 about increased mortality in patients with ventilator-associated bacterial pneumonia. It should be noted that this warning was based only on one trial which was stopped due to safety reasons. No further trial was run, and warning still stands valid. 

Critics believed adjunctive use of aminoglycosides may have influenced the results.

#pharmacology

References:

1. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-approves-label-changes-antibacterial-doribax-doripenem-describing (Accessed on March 29, 2023).

2. Kollef MH, Chastre J, Clavel M, et al. A randomized trial of 7-day doripenem versus 10-day imipenem-cilastatin for ventilator-associated pneumonia. Crit Care 2012; 16:R218.