Personal Injury Law

40 Sickened From Contaminated Generic Diprivan - Recall Launched

By Jane Akre

Different Lots Found At Jackson's

Although there is no known link to the death of Michael Jackson, two lots of the same type of powerful sedative reportedly taken by the star have been recalled after they were found to be contaminated.

The Centers for Disease Control and Prevention (CDC) says two lots of the generic version of Diprivan, also known as propofol, were contaminated with an endotoxin, a bacterial contamination that can cause fever and in a high enough dose can cause shock and death.

Teva Pharmaceuticals of Irvine, California voluntarily recalled the lots, reports CNN.   

Forty reports came in from around the country of people reporting high fevers and muscle aches after being injected with the drug. All of the individuals recovered.  

AP reports the patients were in Florida, Arizona and Missouri and found in a single outpatient facility located in the three states.

The CDC's lead investigator on the case, Dr. Arjun Srinivasan says doctors are being asked not to use propofol from the two lots which are named in a warning letter to doctors as lots 31305429B and 31305430B.

The Associated Press and Los Angeles Times have both reported that police found Diprivan in Jackson's Holmby Hills, California home.  Associated Press is reporting that the number on the lot recalled differs from the number on a vial the DEA found in Jackson's home, the company was told.

Jackson died June 25 of cardiac arrest. Detailed cause of death reports have yet to be issued.

Contamination?

The CDC is not involved in the Jackson investigation but Dr. Arjun Srinivasan, the chief investigator on the recall tells CNN "at high doses, endotoxin can absolutely cause lowered blood pressure and much more serious reactions." He is referring to a decrease in blood pressure which can lead to heart problems.

IB News finds two years ago the FDA issued an Alert to inform healthcare professionals that several clusters of patients had experienced chills, fever, and body aches shortly after receiving propofol for sedation.  The agency tested several vials in the lots used to treat patients with those symptoms. The tests did not identify any contaminants in the vials.   

Teva and the Food and Drug Administration (FDA) will try and determine at what point the contamination occurred.  Altogether 57,000 vials were recalled after the company was contacted by the Drug Enforcement Administration (DEA).  

Diprivan is generally used to keep people and animals asleep during surgery and must be administered by a doctor. Law enforcement is questioning all of the doctors who treated Jackson. 

Three companies make the generic version of Diprivan while the brand-name Diprivan is made by AstraZeneca.  It has not been specified whether a generic or brand-name was found in Jackson's home. 

As part of the Jackson investigation, Teva can provide information on who bought specific vials. The distributors generally sell to hospitals or doctors.  #

Full post as published by InjuryBoard on July 14, 2009 (boomark / email).