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Importance of Using Aseptic Technique with propofol (Dipriva

FDA is alerting healthcare professionals about several clusters of patients who experienced chills, fever, and body aches shortly after receiving propofol for endoscopic procedures. Propofol, which is marketed as Diprivan and also sold generically, is administered IV to induce or maintain general anesthesia and sedation.

The adverse events occurred in several states, and the FDA and CDC are continuing to investigate these reports. To date, there is no evidence that the symptomatic patients had bacterial sepsis, or that the propofol vials or pre-filled syringes were contaminated with endotoxins or bacteria.

Nonetheless, FDA is reemphasizing the importance of handling the drug according to the strict aseptic technique described in the product labeling. Here are several key recommendations:

• Use a vial or pre-filled syringe on only one patient.

• Start giving the propofol immediately after the vial or syringe is opened.

• When using the drug for general anesthesia or monitored anesthesia care sedation, finish administering the drug within six hours after opening the vial or pre-filled syringe. For ICU sedation where propofol is administered directly from a vial, complete administration within 12 hours of spiking the vial. In all cases, discard any remaining drug.

• If a patient develops fever, chills, body aches or other symptoms of acute febrile reactions shortly after receiving propofol, evaluate the patient for bacterial sepsis and treat if necessary.

• Report any adverse events associated with the use of propofol through FDA's MedWatch program.

Video Tags:Propofol, Diprivan, General, Anesthesia, Sedation, FDA, Patient, Safety, Drug, Reaction, Fever, Chills, Body, Ache

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