More than 57,000 vials of the anesthetic propofol, a generic version of Diprivan, have been recalled after testing confirmed that two lots of the medication manufactured by Teva Pharmaceuticals may be tainted. At least 40 people have reportedly been sickened by a bacterial contaminant that got into the drug.
Propofol is a short-acting anesthesia medication which is used for sedation during medical procedures, such as colonoscopy and endoscopy, as well as in dental surgery. It is marketed with the brand name Diprivan by AstraZeneca, and it is currently available as a generic from Teva Pharmaceuticals and other manufacturers.
The U.S. Centers for Disease Control and Prevention (CDC) issued a health advisory on July 13, 2009, warning physicians not to use 100 ml vials of propofol from Teva lots 31305429B and 31305430B. The advisory indicates that the CDC and FDA have been investigating reports of febrile reactions among patients who were undergoing endoscopy at clinics throughout the United States.
“This investigation has revealed that all of the case-patients received the anesthetic propofol from 100 ml vials manufactured by Teva Pharmaceuticals,” reported CDC officials. “Testing done by the FDA has found that two lots of this product that were in use in facilities reporting febrile reactions were positive for elevated levels of endotoxin,”
Reports of propofol side effects have involved individuals who became ill with fevers and chills after having the drug administered at outpatient facilities in Florida, Arizona and Missouri. The CDC indicates that all patients to date have recovered.
The recalled drug has been connected with the controversial death of Michael Jackson, who died on June 25 of cardiac arrest. Preliminary toxicology reports indicate he had a massive amount of drugs in his system and propofol was found in his home following his death. The presence of this anesthetic is unusual because it is normally only delivered by an anesthesiologist and requires that the patient be monitored.
FDA officials and others say it is unlikely the drug played a role in Jackson’s death and the vials found at his home were from different lots than those being recalled.