The FDA has authorized emergency use of Fresenius Propoven 2% Emulsion to maintain sedation via continuous infusion in patients older than 16 who require ICU mechanical ventilation.
Fresenius Propoven 2% Emulsion has important differences in its formulation compared to FDA-approved propofol drugs; providers should consult the Health Care Provider Fact Sheet for more information before administering it.
Severe respiratory illnesses have increased as a result of COVID-19, leading to a shortage of FDA-approved drugs such as propofol that are used for sedation of mechanically ventilated patients.
“Based on the totality of scientific evidence available, FDA has concluded that it is reasonable to believe that the Fresenius Propoven 2% Emulsion may be effective to maintain sedation via continuous infusion,” the agency said in its EUA letter.
The FDA outlined the following scope of authorization:
- Fresenius Propoven 2% Emulsion will be used only to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation.
- Fresenius Propoven 2% Emulsion will be administered only by a licensed healthcare provider in an ICU setting.
- Fresenius Propoven 2% Emulsion will not be administered to pregnant women, unless there are no FDA-approved products available to maintain sedation for these patients should they require mechanical ventilation in an ICU setting.
- Fresenius Propoven 2% Emulsion will be used only in accordance with the dosing regimens as detailed in the authorized Facts Sheets.