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Generic Diprivan Recall: Teva Propofol Contaminated and Linked to Illnesses

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.

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16 comments

  1. Mary Reply

    I have had severe reactions to Propofol on two different occasions. In 2007 it was given to me during a cataract surgery. I was bruised, battered and felt as if I had been raped. I didn’t get the name of the anesthesia used until yesterday, July 16th, even though I had asked repeatedly for it. I should never have been given the drug because of my meds and my heart condition. Bacterial infections are not the only problem with this drug. This past June 2, 2009, I was quickly and unexpectedly intubated during its use for a colonoscopy. Again it should not have been used on me. Are makers of this drug not educating the doctors on its contra-indicators for use or are my doctors in the Rio Grande Valley just into reckless endangerment? I hold all of you responsible who are sold on this sedative and who think this is such a super drug!!! For me it has been pure “HELL” and agonizing trauma with painful joints and muscle spasms. TAKE IT OFF THE MARKET if you are the drug company. If you are a drug representative, then do your job pointing out the dangers.

  2. Rebecca Reply

    During a colonoscopy I was given the drug. I quit breathing had to be incubated and then ended up with pneumonia from the ordeal this was the last week of OCT 2008.

  3. Kathy Reply

    I attempted suicide while under the influence of Ambien

  4. John Reply

    In 2007 the FDA issued the following warning

    DA 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.

    You can register to recieve email alerts about your medicine at http://www.checkdrugs.com

  5. Ariella Reply

    IN 2007, a doctor agreed with me to not sedate a closed family member of mine because of opioid allergic reactions and other conditions.
    the doctor went behind my back and administered propofol/diprivan-after taking it, the person was sweeting, couldn’t swallow, had a flu-like symptom, pneumonia, crakle, discomfort, breathing difficulty, was in shock, his hands and feet were numbed, had respiratory distress each time a nurse administered propofol/diprivan, the person also developped hypotension, acute respiratory failure, had accumulation of fluid while in the feeding tube and ventilation, the vent. pump alert a noise and the person developped tachycardia, within seconds the person was in bradycardia state and died of bradycardia and cardio respiratory arrest.
    the high endotoxin level is not the only problem of propofol/diprivan; therefore, the evidence of patients to develop fever, chills, abdominal ache, hypotention, respiratory distress, then acute respiratory failure, tachycardia, bradycardia, cardio respiratory arrest and deaths after taking propofol/diprivan are enough evidence to remove this drug from the market.
    I don’t care if endotoxin wasn’t found in 2007; propofol/diprivan contribute to the death of the person I’m talking about and the pharmaceutical companies should be held accountable.
    They lied in the label that some conditions are rare while patients experience them while taking propofol and even after they stopped the drug.
    propofol/diprivan causes many to not return home after hospitalization-some patients died or paralysed in a nursing home because of it. after taking it, the person who never smoked developped emphyzema out of the blue and other lung condition.
    First of all, the person should not be on this drug at all. The FDA should reconsider and initiate a class 1 recall for all propofol back in 2007 or further year-the search about two Teva lots of propofol were only tainted is not conclusive nor significant.
    If a person develop allergic reactions to opiods and azo drugs, propofol/diprivan is more powerful and can kill patients-that’s what happened; the patients died at the hospital.
    go back and reconduct the research because all patients taking propofol/diprivan in 2007 that I knew died from days to a month after taking and this is how dangerous this is. Before they died they go back and forth to ICU or CCU and go into respiratory distress and acute respiratory failure.

  6. ariella Reply

    Two lots were contaminated. are the hospital and the pharmaceutical company send a dear letter to alive patients or families? I doubt it.

    they are more likely to protect the pharmaceutical companies.

  7. George Reply

    I, was given med. on July30,2009.Developed sore muscles the next day.I, was told could,nt have anything to do with med. and was hospitalized in serious condition 11 days later after spreading through my body.

  8. liz Reply

    I was given drug for a colonoscopy and a few days later had a severe kidney stone. where do I find out about class action suit?

  9. idiot Reply

    I was given propofol and now I find myself constantly wanting to sing German operas – and I couldnt even speak German before that! I WANT MONEY – class action law suit!

  10. Another Idiot Reply

    I don’t know anything about how these drugs work but I heard once that someone got propofol and lT made him die. Can I sue somebody? Is there areason anyone uses this drug for anything even though people are dying every day in car accidents? I want my money back.

  11. Marietta Reply

    I was given Diprivan close to a week ago for a colonoscopy. I have been put to sleep over 20 times in my lifetime and have never had a reaction to anesthesia before, but then again this was my first time having Diprivan. I woke up from the procedure feeling very Euphoric. My son told me the next day that I asked him to take me to a restaraunt where I went in and ordered food to go and I ate it in the car ( I don’t remember). I went to bed and woke up a few hours later thinking it was the next day. I got ready for work and everyone had to tell me what day it was. The next day I began running a low grade fever and migraine headache that I’m still dealing with today. I have sharp eye/head pain at times. My neck, back and shoulders are stiff and achy. I’m suffering from severe fatigue. All I want to do is sleep and I don’t want to wake up in the morning. This is 100% out of character for me. I have been a type A personality since the day I was born. I have bouts at least every hour where I feel very spacey, Euphoric, confussed and my speech doesn’t make sense at times. I go to say something and what I’m thinking and what comes out of my mouth are totally bizarre. I just stand there and think, “Where the He** did that come from!!!” Also, my son told me that when he was driving me home from the procedure that every sentence I spoke was a different topic. I don’t remember any of it. I’m scared. I don’t know how long I’m going to be like this. Can anyone help?

  12. Sarah Reply

    Back in 2003, I had my wisdom teeth removed. I was 18 years old, and it was my first surgery (outpatient). After the surgery, I remember the nurses shaking me awake; I suppose, to get me out of there for the next patient.

    Shortly after my dad drove me away from the clinic, I began to feel like it was a chore just to breathe. I said “Dad, I feel like I can’t breathe”, and my hands fell to my side. However, I didn’t passout. I just couldn’t move or open my eyes. My dad rushed me back to the clinic, and they began to shove IV needles in my hands and arms. I believe my veins were collapsing but to this day am not certain why they had to do it so many times.

    I could hear and feel everything. My body began to shake every few minutes. Forty-five minutes later, the doctor finally called an ambulance. I remember my dad saying “why aren’t you using the sirens?!” Poor man was about to have a heart attack, and all I could do was lay there with my eyes closed unable to move. Once the female paramedic placed that strong smell under my nose, I could feel my strenght coming back.

    However, just before I woke up the male paramedic asked something to the effect of my waking up or responding, and she stated “Yeah, when you’re not looking at her”.

    It’s my belief that I had a horrible and rare reaction to this drug, Diprivan. Apparently neither the doctor nor the paramedics were taking the incident seriously, and I would even go as far to say the doctor believed I was faking and told the paramedics this.

    However, I finally was able to open my eyes while they were pushing me out of the ambulance, and I began to cry uncontrollably. Once I was stabilized in the ER, one of the nurses said she also had the drug Diprivan for a surgery and had the same exact reaction.

    Well that’s my long sob story. Just wanted to put it out there for once.

  13. Pat N Reply

    Whenever I am about to receive a generic drug, I request that NONE be from TEVA. I had serious adverse reactions to lamotrigine
    (lamictal) , and the effect from zolpidem (ambien) was not typical. I was reminded of these when I saw that the vial of propofol shown on a Michael Jackson biography said TEVA.

  14. BP Reply

    Teva is not to blame for the high patient endotoxin levels. High endotoxin levels are often found during opiate withdrawal.

    To get an idea of what is happening in drug withdrawal, there is a granted patent that in fact uses endotoxins to reduce the effects of opiate withdrawal. This would create an allergic immunologic reaction to endotoxins, which are being created in the patient intestines and released because of the drug withdrawal.

    Propofol is perhaps the most addictive drug known to man.

    I give Teva applause for removing this drug from its product list, quickly and efficiently.

  15. Bud Reply

    I have never used prescription drugs all my 80 years of life ( except 12.5mg of BP meds ) until I had a quarter size small nose cancer removed from my nose by one Dr. in his office then sent to hospital to have the other Dr. Plastic Surgeon to put a closure flap on it. They used Profofol for the anesthesia and when I awoke in the recovery room they discovered I had A-Fib and held me for one hour until it finally retarded but they kept me over night and the Cardiologist said that I would have to take coumadin as a blood thinner ! I refused that and he then put me on Plavix. That was in Oct 2010 and now I had A-Fib again and the New Cardiologist zapped me twice to get the heart back in rythym ! That was this July 2011 and he then gave me Sotalol 8o mg. and that put it back into rythym in Aug 2011 ! However I am so weak and without energy but breathing better now so hopefully will come off the Sotalol in Feb 2012. PROBLEM: I have always had great health and a heart before the Cancer Operation that was as one of 40 years of age accdording to the Cardiologist. Ever since that time I have had nothing but trouble with low energy that does not allow me to do chores around the house like before, rash, dizzeness at times, and now feel like a 100 year old. Will the Propofol cause that as it is the only thing that I have had to make me that way. ? Thank You

  16. Leah Reply

    My 15 year old son was put to sleep with Propofol for an outpatient surgery a year and a half ago. He went in fine and ever since he has been in unliveable agony, saying he “feels horrible” 24/7 and can barely stand or walk a minute. If he does he gets much sicker and confused. We found out his heart rate is going up too high upon standing. I don’t know what do, his blood tests all come out normal. No pain medicines work for him. He lives in torment 24/7. He’s been in hospitals, to numerous doctors and hospitals to no avail. I don’t know how a human can continue to live this way. It’s awful to watch and not be able to help him.

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