July 15, 2009 - U.S. Agents Contact Drug Maker in Jackson Probe
A maker of the potent anesthetic propofol found in Michael Jackson's home has been contacted by federal officials investigating the pop star's death and has recalled tens of thousands of vials of the drug after two tainted lots sickened dozens of patients.
There is no apparent connection between the bacterial contamination that prompted the recall and Jackson's death on June 25, Teva Pharmaceuticals spokeswoman Denise Bradley told The Associated Press on Tuesday. The tracking number on the tainted lots was different from the number on a vial that Drug Enforcement Administration investigators told the company was found at Jackson's home, she said.
Propofol usually is administered intravenously in hospitals to patients who need to be unconscious for surgery or other procedures. A central question in the Jackson investigation is who provided that drug and other prescription medications found at his rented Beverly Hills mansion. Investigators are talking to doctors who treated Jackson.
Jackson investigators are seeking to trace how propofol ended up in his home. Teva can provide information on which distributor bought specific vials. From there, distributors typically sell directly to hospitals or doctors.
Bradley said she didn't know which distributor handled the drug found at Jackson's home. DEA spokesman Rusty Payne declined to comment.
Teva announced it was recalling two lots of propofol - 57,620 vials in all - after concluding bacterial contamination caused up to 40 patients in Florida, Arizona and Missouri to develop fevers and chills since May. Investigators believe vials were distributed nationally and are urging doctors not to use any propofol from the two lots.
Most of the affected patients were undergoing an endoscopy, an examination in which a tube-like instrument, usually with a camera attached, is passed into an area of the body such as the colon or esophagus. One patient was hospitalized and all recovered, said Dr. Arjun Srinivasan, lead investigator for the U.S. Centers for Disease Control and Prevention.
Karen Riley, spokeswoman for the Food and Drug Administration that oversees drug recalls, said the contamination was found in a single outpatient facility in each of the three states. She did not identify the sites.
FDA investigators arrived Monday at the Teva plant in Irvine, Calif., where the suspect lots were made and were looking for any irregularities in the manufacturing process, Riley said.
Investigators believe that bacteria in vials of the anesthetic released toxins into the drug which caused the fever, Srinivasan said.