Gov't Issues Warning Over Propofol

We've learned the FDA and CDC have issued a warning over certain batches of Propofol -- the drug found in Michael Jackson's home on day he died and the drug that may have killed him.

As far as we know the investigation is not related to Jackson, but certain lots from a pharmaceutical company in Irvine, Calif. have proven to be "tainted" and the company has issued a voluntary recall.

There have been no fatalities and so far the cases have only been reported in Florida, Arizona and Missouri -- but the CDC is urging physicians across the country to check their inventories because the product was distributed nationwide.

Tags: FDA, michael jackson, MichaelJackson, propofol, recall

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31. Whether or not the drug was tainted it should NEVER have been administered outside the hospital in someone home!!

Posted at 5:14PM on Jul 14th 2009 by Lauren

32. POWER,MONEY,WILL WALK.DR TOHME WHAT WAS HIS ROLE.MJ DEMANDS TO HIRE DR MURRAY,THE PLOT WILL GROW.IF IT DOES NOT FIT YOU CAN NOT CONVICT.TIME WILL CONVICT.TMZ FANS KEEP UP THE WORK.

Posted at 5:18PM on Jul 14th 2009 by AEG AND DOCTORS

33. According to FDA, the reports describe patients at seven health care facilities in Pennsylvania, New Jersey, New York, and Tennessee. One of the affected patients had a seizure and one required hospitalization, but all of the patients have recovered, FDA stated.

In all cases, the symptoms started 6–18 hours after the administration of propofol and continued for up to three days, according to FDA. All of the patients had received propofol for gastrointestinal procedures.

FDA stated that the symptoms are similar to those reported when propofol was first introduced to the U.S. market in a formulation that contained no preservatives or microbicides. None of the new cases have been shown to involve bacterial or endotoxin contamination of the propofol vials or prefilled syringes or ancillary medications such as lidocaine.

In some of the new cases, single-use vials of propofol were used for multiple patients, a practice that FDA deems inappropriate. The agency also emphasized that once a vial or syringe has been opened for use in general anesthesia, administration of the product must begin immediately and be completed within six hours.

When propofol is used for sedation in an intensive care unit, the same precautions apply, except that administration must be completed within 12 hours after opening the vial.

FDA stated that although current formulations of propofol contain "an ingredient that retards the growth of microorganisms," microbial growth is still possible and precautions must be taken to ensure the product's sterility.

The agency stated that it is visiting the sites from which the reports originated and working with the Centers for Disease Control and Prevention (CDC) to investigate the cause of the reported illnesses.

Posted at 5:53PM on Jul 14th 2009 by iwasthere

34. OH SURE! Now the crap is tainted. Let's see; COULD IT BE THAT A BATCH OF IT, FOUND IN LA, WAS TAINTED? RIGHT! MURDER! MURDER! MURDER! BY A DUMB ASS DOCTOR!

Posted at 6:06PM on Jul 14th 2009 by reapwhatUsew

35. YIKES ! i was given this drug last thursday (6/9) and i don't feel so well . . . AND i live in Florida !
what are the symptoms ?

Posted at 7:44PM on Jul 14th 2009 by recipient

36. WOW! This is all BS. The FDA and the CDC is not responsible for this. The authorities just want physicians across the country to check their inventories so they can find out who had possession of those particular lot numbers on the bottles of propofol found in Michael’s house. Duh! Not stupid.

Posted at 6:33PM on Jul 14th 2009 by reapwhatUsew

37. tainted w/ what, omg my 16y daughter had this yesterday for dental surgery to remove wisdom teeth, we live in tennessee, do i need to worry about anything?

Posted at 6:47PM on Jul 14th 2009 by tina vanfossen

38. WTH is going on? FDA issued this warning in [B]2007[/B]

FDA issued warning for Propofol in 2007

Diprivan (propofol)

Audience: Surgeons, anesthesiologists, healthcare professionals

[Posted 06/15/2007] FDA informed healthcare professionals about several clusters of patients who experienced chills, fever, and body aches shortly after receiving propofol for sedation or general anesthesia. Multiple vials and several lots of propofol used in patients who experienced these symptoms were tested and there was no evidence that the propofol vials or prefilled syringes used were contaminated with bacteria or endotoxins. Propofol is an intravenous sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation. To minimize the potential for bacterial contamination, propofol vials and prefilled syringes should be used within six hours of opening and one vial should be used for one patient only. Patients who develop fever, chills, body aches or other symptoms of acute febrile reactions shortly after receiving propofol should be evaluated for bacterial sepsis. Healthcare professionals who administer propofol for sedation or general anesthesia should carefully follow the recommendations for handling and use in the product's full prescribing information.

[June 15, 2007 - Drug Information Page - FDA]

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152114.htm

Posted at 6:41PM on Jul 14th 2009 by Athena

39. After my father died from the chemotherapy drug fludarabine, I took dowsing courses. To check if any food, drug etc is safe, you put the object on the right, place your left hand beside the object to the left of it. Then take a pendulum and ask if the object is compatible with you. If the pendulum moves sort of up and down creating a wall between you and the object, stay away from it. If the pendulum swings across between the object and your left hand, it is theoretically ok for you.

Posted at 7:23PM on Jul 14th 2009 by peasantgirl

40. It's going to take many years to get all of this settled.

Posted at 7:59PM on Jul 14th 2009 by Linda Mott

41. 39. YIKES ! i was given this drug last thursday (6/9) and i don't feel so well . . . AND i live in Florida !
what are the symptoms ? Posted at 7:44PM on Jul 14th 2009 by recipient

First fever then followed usually by flu like symptoms. This stuff shows up in IV drugs/meds when docs or vets use bottles multiple times when they are specified for once. Because this drug is needed in such small amounts and is titrated with IV fluids it is probably a given there is amount left in the bottle and it might be reused.
Even in untainted bottles multiple use w/o proper precautions can introduce a bacteria to the bottle resulting in patient illness.

Since stories are MJ was shopping hard for this drug he may have done multiple uses reintroducing syringe needles into the bottle, he could have developed some type of reaction, fever, illness from it and the next dose he usually got overwhelmed his respiratory system.

It just seems odd to me that someone who had supposedly used the drug for years would have such a reaction and die as he did...unless the person administering it was new to the routine/drug or the bottle had gone bad.

Posted at 8:14PM on Jul 14th 2009 by zip

42. When I want to know if my drugs are safe to take, I ask the little voices in my head.

If they tell me that the drugs are safe, I take them.

If they tell me that the drugs are not safe, I put them in the Halloween candy and give it to the neighborhood kids.

If you don't like my post, I will ask the little voices what to do about you.

Posted at 8:31PM on Jul 14th 2009 by Ralph Wiggims

43. Tom Green just posted this on Twitter: www.twitter.com/tomgreenlive

Michael Jackson is buried at Neverland Ranch. Re tweet it!!!
The cement truck that showed up at Neverland days after his death was to cover the burial plot! He was not at Staples in the casket.
about 1 hour ago from web

Michael Jackson is buried at Neverland Ranch. The media has not reported this yet. You heard it first! Tweet!
about 1 hour ago from web

Posted at 8:59PM on Jul 14th 2009 by Someone Who Knows

44. Ok everyone time to get off the doctors back. This has proven he did nothing wrong. The drug was tainted which can happen with drugs. It's nobody elses fault but MJ's for taking a drug he didn't need. A million little kids can breathe easier now.

Posted at 9:04PM on Jul 14th 2009 by Total Package

45. Strict aseptic technique must always be maintained during handling. Diprivan Injectable Emulsion is a single-use parenteral product which contains 0.005% disodium edetate to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental extrinsic contamination. However, Diprivan Injectable Emulsion can still support the growth of microorganisms, as it is not an antimicrobially preserved product under USP standards. Accordingly, strict aseptic technique must still be adhered to. Do not use if contamination is suspected. Discard unused portions as directed within the required time limits (see DOSAGE AND ADMINSTRATION, Handling Procedures). There have been reports in which failure to use aseptic technique when handling Diprivan Injectable Emulsion was associated with microbial contamination of the product and with fever, infection/sepsis, other life-threatening illness, and/or death.

Posted at 9:49PM on Jul 14th 2009 by Information....research is GOOD ..More should try it

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