Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The anesthetic that may be linked to the death of pop star Michael Jackson has been recalled by the Food and Drug Association (FDA) due to the presence of elevated endotoxin levels that may be linked to severe adverse reactions in patients following use of the drug. Teva Pharmaceuticals announced it is recalling specific lots of propofol injectable emulsion, 10 mg/mL 100 mL vials after it was notified of 41 propofol-treated patients who experienced post-operative fever, chills and other flu-like symptoms.

Adverse health events such as fever, chills, or rigors are possible with exposure to products with high endotoxin levels. Serious adverse effects, such as disseminated intravascular coagulapathy, acute respiratory distress syndrome, shock, and death, are possible with exposure to products with high endotoxin levels. Affected lots of propofol injectable emulsion include numbers 31305429B and 31305430B.

Propofol was among the drugs found in Jackson’s home, and an investigation into his sudden death is still underway. Propofol is a powerful anesthetic and not meant for home use. Among other questions, investigators want to know how the drugs ended up in the singer’s home.

Teva stresses, for use as an anesthetic agent, propofol should be used only by professionals trained in the administration of general anesthesia. For sedation of intubated, mechanically ventilated patients in the Intensive Care Unit, propofol should be administered only by persons skilled in the management of critically ill patients.

Consumers with questions about propofol may contact 1-866-262-1243 from 8:00 am – 8:00 pm EDT Monday – Friday.

Sources:
FDA
New York Times

This entry was posted on Saturday, July 18th, 2009 at 11:55 am and is filed under product liability. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.