May 30, 2007

 

Propofol Safety Signal

In the past several months several clusters of cases involving propofol have been reported to the Adverse Event Reporting System used by the FDA to monitor drug safety. These cases are reminiscent of the cases 15 years ago involving propofol contamination. Patients have developed fever and “flu-like symptoms” that persist for many hours after propofol administration. Several patients have been hospitalized. No long-term morbidity has been reported.

The FDA is gathering more data on this. In the interest of promoting patient safety, ASA wishes to share two observations with our members:

1) Propofol formulations have been associated with bacterial growth. It is important to follow the Package Insert guidelines for aseptic technique when handling propofol.

2) Any patient who experiences a fever or other symptoms of infection following propofol should be followed up carefully, including blood cultures if possible. These cases should be brought to the attention of the FDA, as well as your State Department of Health and the CDC:

Adverse events, product quality problems and/or product use errors can be reported to FDA's MedWatch Adverse Event Reporting Program using one of the following options:

• on-line at www.fda.gov/medwatch/report.htm;
• by returning the postage-paid FDA form 3500 [available in PDF format at www.fda.gov/medwatch/getforms.htm to 5600 Fishers Lane, Rockville, MD 20852-9787 or faxing the form to 1-800-FDA-0178; or
• by phone at 1-800-332-1088

From the CDC:
Centers for Disease Control and Prevention is investigating reports of nonrespiratory febrile reactions beginning approximately 6-18 hours after gastrointestinal endoscopy procedures. Cases have occurred since April 1, 2007.  We are interested in hearing from others who might have seen similar cases. If you have seen similar cases, please contact David Blossom (404-639-4514) or Arjun Srinivasan (404-639-2303) at CDC.