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Michael Jackson's Ghost Spooks Propofol Maker TevaThe worldwide scorn directed at those closest to Michael Jackson in his final days may have extended to the drug Propofol and its Irvine-based maker, which announced it is laying off 200 employees this year after having already let go 70 workers.Teva Pharmaceuticals maintains it already discontinued the hypnotic drug--not because of Jackson's death, but because Propofol was hard to manufacture, the company got little or no profit from it and there were pending lawsuits tied to it.Risks from the nonmedical use of Propofol were greatly exposed when the Los Angeles County coroner concluded in August 2009 that the King of Pop died from a mixture of Propofol--nicknamed "Milk of Amnesia"--and the benzodiazepine drug Lorazepam. Ten bottles of Propofol were found in Jackson's home.Propofol and Teva, which is headquartered in Israel, have had a rocky relationship. The company previously halted production and recalled some Propofol in 2009 after 41 patients fell ill with flu-like symptoms. That fueled several of the lawsuits.Teva announced it will kill 195 of its Irvine jobs by Feb. 6, according to an Orange County Register report."Our Irvine, California, facility has been under a voluntary manufacturing and distribution hold since April 2010," said Denise Bradley, Teva spokeswoman in a company statement. "Prior to this reduction, we have not laid off any employees as a result of this voluntary production hold. The jobs that are being eliminated are all various production jobs and support staff at the facility."'They should moonwalk out to their cars.You are not allowed to view links. Register or Login
Mid July 2009 the first recalls of Propofol were published by the FDA for safety reasons (bacterial contamination of the product). The timing is not astonishing - the name of Propofol was in all newspapers after Michael's "passing". However:QuoteA Teva spokeswoman said the company had been contacted by the Drug Enforcement Administration about a lot number on a specific propofol vial "in relation to an investigation they are conducting," which she did not confirm or deny involved the Jackson death.That lot number, she said, is not one of those involved in the recall. You are not allowed to view links. Register or LoginQuoteMore than 57,000 vials of Teva-manufactured propofol were recalled after 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 two lots. One of main manufacturers of Propofol is TEVA, another is Hospira. Teva received a warning from FDA in April 2010 after they had to recall 100 ml vials from the market:QuoteTeva Pharmaceuticals failed to have proper quality control measures in place to prevent bacterial contamination from entering batches of their generic version of the anesthetic propofol, leading to a recall last year after at least 40 people became ill, according to federal inspectors. You are not allowed to view links. Register or LoginTeva stopped production thus resulting in a product shortage in the U.S.QuoteThe Teva propofol recall, and another propofol recall by Hospira, Inc. due to particulate matter contamination in November, has caused a shortage of propofol in the United States. As a result, the FDA has given APP Pharmaceuticals Inc. permission to import Propoven, a similar drug, into the U.S. Propoven has not been approved by FDA, but is in use in a number of other countries around the world.You are not allowed to view links. Register or LoginWhere do the contaminations result from?Quote The drug is available as an aqueous lipid emulsion (Dipdvan| ICI Pharmaceuticals) containing I% propofol, 10% soyabean oil, 1.2% egg phosphatide and 2.25% glycerol. Product information provided with propofol states that the preparation should be "... drawn aseptically into a sterile syringe ... immediately alter opening the ampoule" and that it should be injected "... without delay." Despite these recommendations, it is often difficult in clinical practice to ensure that there is no delay between drawing- up and administration. Therefore propofol can often be left standing in a sterile syring~ for some period of time prior to administration. You are not allowed to view links. Register or LoginQuoteThe intravenous anaesthetic propofol may become contaminated once the ampoules have been opened. [...] When propofol is stored in opened ampoules, the bacterial contamination rate is high.You are not allowed to view links. Register or LoginQuotePropofol can support rapid microbial growth and endotoxin production. To avoid infectious complications, scrupulous aseptic technique should be used when preparing or administering this anesthetic. You are not allowed to view links. Register or LoginFDA issued a warning about proper handling in 2007 already.You are not allowed to view links. Register or LoginQuoteEscherichia coli is one of the most frequent causes of many common bacterial infections, including cholecystitis, bacteremia, cholangitis, urinary tract infection (UTI), and traveler's diarrhea, and other clinical infections such as neonatal meningitis and pneumonia.Drawing out a case that has not yet been subject to interest:We face three sources of contamination of the product with bacteria:1) the fact that the product is containing soy bean oil which as a lipid supports bacteria growth2) improper manufacturing3) improper handling at anesthesia administration in divergence to guidelines Quote Therefore propofol can often be left standing in a sterile syring~ for some period of time prior to administration. For some anaesthetists, this delay is on occassion deliberate with several induction doses prepared in advance for an operating list. The problem of clinical practicalities occasionally resulting in diver- gence from package insert guidelines has been previously identified, l but not quantified. You are not allowed to view links. Register or Login
A Teva spokeswoman said the company had been contacted by the Drug Enforcement Administration about a lot number on a specific propofol vial "in relation to an investigation they are conducting," which she did not confirm or deny involved the Jackson death.That lot number, she said, is not one of those involved in the recall.
More than 57,000 vials of Teva-manufactured propofol were recalled after 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 two lots.
Teva Pharmaceuticals failed to have proper quality control measures in place to prevent bacterial contamination from entering batches of their generic version of the anesthetic propofol, leading to a recall last year after at least 40 people became ill, according to federal inspectors.
The Teva propofol recall, and another propofol recall by Hospira, Inc. due to particulate matter contamination in November, has caused a shortage of propofol in the United States. As a result, the FDA has given APP Pharmaceuticals Inc. permission to import Propoven, a similar drug, into the U.S. Propoven has not been approved by FDA, but is in use in a number of other countries around the world.
The drug is available as an aqueous lipid emulsion (Dipdvan| ICI Pharmaceuticals) containing I% propofol, 10% soyabean oil, 1.2% egg phosphatide and 2.25% glycerol. Product information provided with propofol states that the preparation should be "... drawn aseptically into a sterile syringe ... immediately alter opening the ampoule" and that it should be injected "... without delay." Despite these recommendations, it is often difficult in clinical practice to ensure that there is no delay between drawing- up and administration. Therefore propofol can often be left standing in a sterile syring~ for some period of time prior to administration.
The intravenous anaesthetic propofol may become contaminated once the ampoules have been opened. [...] When propofol is stored in opened ampoules, the bacterial contamination rate is high.
Propofol can support rapid microbial growth and endotoxin production. To avoid infectious complications, scrupulous aseptic technique should be used when preparing or administering this anesthetic.
Escherichia coli is one of the most frequent causes of many common bacterial infections, including cholecystitis, bacteremia, cholangitis, urinary tract infection (UTI), and traveler's diarrhea, and other clinical infections such as neonatal meningitis and pneumonia.
Therefore propofol can often be left standing in a sterile syring~ for some period of time prior to administration. For some anaesthetists, this delay is on occassion deliberate with several induction doses prepared in advance for an operating list. The problem of clinical practicalities occasionally resulting in diver- gence from package insert guidelines has been previously identified, l but not quantified.
Hospira Issues Second Drug Recall in 6 Months on FDA Warning-Bloomberg04/16/2010 - Hospira Inc. recalled two drugs for the second time in six months because of manufacturing defects that prompted an April 12 warning letter from the U.S. Food and Drug Administration, said Dan Rosenberg, a company spokesman. The drugs -- Propofol, an anesthetic agent, and Liposyn, an intravenous nutritional product -- were recalled on April 1, Rosenberg said. The company told the FDA the products had been contaminated by particulates during the manufacturing process, he said. The drugs are sold to hospitals and doctors. More>>>Teva Pharmaceuticals USA issues a voluntary nationwide recall of Propofol Injectable Emulsion-FDA12/17/2009 - In July of 2009 Teva Pharmaceuticals USA initiated a voluntary recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B. The product lots identified are being recalled due to the presence of elevated endotoxin levels in some vials within these lot numbers. More>>>Hospira Brand Propofol and Liposyn Products - Recall-FDA11/11/2009 - Hospira, Inc.and FDA notified healthcare professionals of the recall of 85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30%, and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80 because some of the containers may contain particulate matter. The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process. More>>>Hospira Issues Nationwide Voluntary Recall of Certain Lots of Liposyn and Propofol Products That May Contain Particulate Matter-Pharmaceutical Processing11/12/2009 - Hospira, Inc., a global specialty pharmaceutical and medication delivery company, is voluntarily recalling 85 lots of Liposyn™ II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30% and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80 because some of the containers may contain particulate matter. More>>>If you or a loved one have suffered injury or loss as a result of contaminated Propofol or Liposyn you may be entitled to compensation. Contact The Propofol Lawyers of Ennis & Ennis, P.A. today for a free case evaluation by filling out the form on this page or calling toll-free 1-800-856-6405.
Someone on my facebook list-a non believer did a note thing about her operation and her whole drama in hospital(I have no idea why but she did lol)and she said she got given propofol for her op.She slipped on some ice and broke her wrist and the op was to straighten it out so it didn't heal weird.She also said something about feeling really drowsy when coming round from it and there was no way she could have done anything let alone inject herself with more.
Quote from: "Sinderella"Someone on my facebook list-a non believer did a note thing about her operation and her whole drama in hospital(I have no idea why but she did lol)and she said she got given propofol for her op.She slipped on some ice and broke her wrist and the op was to straighten it out so it didn't heal weird.She also said something about feeling really drowsy when coming round from it and there was no way she could have done anything let alone inject herself with more.That's strange. I have been put down with propofol once for my knee surgery and I was gone in 2 seconds and awake even faster. Not sleepy and not drowsy at all. It was like I had never been away and I wanted to get out of bed and eat.
Quote from: "~Souza~"Quote from: "Sinderella"Someone on my facebook list-a non believer did a note thing about her operation and her whole drama in hospital(I have no idea why but she did lol)and she said she got given propofol for her op.She slipped on some ice and broke her wrist and the op was to straighten it out so it didn't heal weird.She also said something about feeling really drowsy when coming round from it and there was no way she could have done anything let alone inject herself with more.That's strange. I have been put down with propofol once for my knee surgery and I was gone in 2 seconds and awake even faster. Not sleepy and not drowsy at all. It was like I had never been away and I wanted to get out of bed and eat. Well she is a non believer,she might have been lying to prove the whole Michael died at the hands of Murray BS,i'm just trying to find the note on fb now.LIKELY.I'm allergic to anaesthetic and have to be strapped down because I fit/fight the surgeons and take my socks and heart monitor's off and all kinds haha!I end up in a room on my own.I might ask for prop fool for this knee surgery I have to have soon and report back on my reactions,i'll tell them it's all the rage in Holland
Yea Souza, I think there are a couple of ways they give it and one of them the patient gets a shot of something else first (don't know what that is) and then Propofol will maintain the anesthesia. The other is straight dosing,(which my son had to maintain his coma longer to heal his brain, and yep, soon as it came off after days on it he was wide awake in what seemed like seconds.