Random? Or Related? FDA Issues Warning Against Anti-Freeze

David Goldstein, a Seattle talk show host, points out this press release from the FDA today:

Today, the agency is issuing guidance to industry recommending methods of testing glycerin and other controls to identify any contamination with DEG before use in the manufacture or preparation of pharmaceutical products.

David says:

Hmm. Glycerin is an ingredient sometimes used in pet food. Diethylene glycol is a poison used in antifreeze, that is known to cause renal failure. Thousands of dogs and cats have died from renal failure, supposedly due to melamine, an industrial chemical not previously known to be highly toxic.

Can’t help but wonder.

When reports of pet kidney failures were first reported, anti-freeze was one of the first suspects named by many people. FDA says the release is unrelated to the pet food recalls.

Full release after the jump.

FOR IMMEDIATE RELEASE
P07-81
May 4, 2007

Media Inquiries:
Kimberly Rawlings, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Advises Manufacturers to Test Glycerin for Possible Contamination
Glycerin Contaminated with Diethylene Glycol (DEG) Remains a Potential Health Hazard to Consumers

The U.S. Food and Drug Administration (FDA) is warning pharmaceutical manufacturers, suppliers, drug repackers, and health professionals who compound medications to be especially vigilant in assuring that glycerin, a sweetener commonly used worldwide in liquid over-the-counter and prescription drug products, is not contaminated with diethylene glycol (DEG). DEG is a known poison used in antifreeze and as a solvent. Today, the agency is issuing guidance to industry recommending methods of testing glycerin and other controls to identify any contamination with DEG before use in the manufacture or preparation of pharmaceutical products.

At the present time, FDA has no reason to believe that the U.S. supply of glycerin is contaminated with DEG, though the agency is cognizant of reports from other countries over the past several years in which DEG-contaminated glycerin has caused human deaths. FDA is emphasizing the importance of testing glycerin for DEG due to the serious nature of this potentially fatal problem in combination with the global nature of the pharmaceutical supply chain and problems that continue to occur with this kind of contamination in some parts of the global supply of glycerin.

DEG poisoning is an important public safety issue and FDA is exploring how supplies of glycerin become contaminated. In addition, FDA is working with a variety of manufacturing and pharmacist organizations to raise awareness of this risk and to put into place controls to ensure that this problem does not happen in the U.S. or elsewhere.

The most recent incident occurred in Panama in September 2006 and involved DEG-contaminated glycerin used in cough syrup, which resulted in dozens of hospitalizations for serious injury and more than 40 deaths. In late 1995 and early 1996, at least 80 children died in Haiti due to DEG-contaminated glycerin in acetaminophen syrup. Between 1990 and 1998, similar incidents of DEG poisoning reportedly occurred in Argentina, Bangladesh, India, and Nigeria and resulted in hundreds of deaths. In 1937, more than 100 people died in the United States after ingesting DEG-contaminated Elixir Sulfanilamide, a drug used to treat infections. This incident led to the enactment of the Federal Food, Drug, and Cosmetic Act, which is the nation’s primary statute on the regulation of drugs.

FDA reminds pharmaceutical manufacturers, compounders, repackers, and suppliers, as well as brokers and distributors, that all pharmaceutical manufacturing operations, including the re-packaging and re-labeling of ingredients like glycerin, must conform to current good manufacturing practice (CGMP). The guidance provides recommendations for complying with CGMP and is intended to help manufacturers, compounders, repackers, and suppliers avoid the use of glycerin that is contaminated with DEG and prevent incidents of DEG poisoning.

For a copy of the guidance, go to http://www.fda.gov/cder/guidance/7654fnl.htm

####

29 Responses to “Random? Or Related? FDA Issues Warning Against Anti-Freeze”

  1. Carol says:

    When I brought my sickest cat into my vet 3 weeks after my 1st cat—he said (and wrote in her chart) looks like antifreeze poisoning—Hmm-he said we’ll know because IF she survives, it’s not–well she still alive 7 weeks later but gravely ill—does make me wonder if her melamine cocktail had a side of antifreeze–

  2. susanUnPC says:

    Thanks so much, Itchmo. This rang a bell, and I went hunting … here’s what I read about this yesterday, posted by a member of the Young Turks radio show:

    [QUOTE] “The suspicion of international contamination is eerily similar to past incidents in China,” Barton said. “A dozen years ago, 89 children in Haiti died after taking cough medicine made with, believe it or not, poisonous antifreeze that was traced back to China. The world never got an answer from the Chinese on how this crime occurred.

    “In an investigation started in 1998 when I was the chairman of this subcommittee, we found that 155 Americans were sickened by impure gentamicin sulfate made by a Chinese firm,” Barton continued. “We never got a definitive answer on how this unapproved, impure drug ingredient got into that particular product.” [/QUOTE]

    FULL LINK TO STORY:
    http://www.consumeraffairs.com.....afety.html

    This was posted yesterday at Daily Kos by Nonie3234 — The Young Turks, the first nationwide liberal talk show and first live, daily internet TV show
    http://www.theyoungturks.com/

  3. Annie C. says:

    Anyone know what the symptoms of antifreeze poisoning in humans are?

  4. mal says:

    This is very interesting considering the recall in South Africa was inititally blamed on anti-freeze, then changed to contaminated corn gluten.

    What else is being hidden from us??

  5. mal says:

    Antifreeze poisoning occurs in two stages: In the first stage, the ethylene glycol in the antifreeze causes a drunken appearance in the animal within about 30 minutes which may continue for several hours. After passing through stage 1, the animal appears to recover. Stage 2 begins when the dog’s liver begins metabolizing the ethylene glycol, changing it into more toxic substances. Within 12 to 36 hours of ingestion, these metabolites have reached such a level that the dog’s kidneys stop functioning, and the animal slips into a coma.

    http://www.petshealth.com/dr_l.....reeze.html

  6. ann says:

    Greenies dog and cat treats contains a preservative that is one molecule away from antifreeze. From what I read about this derivative -propyll gallate- it is widely used in pet and human products…..

  7. Sandy says:

    Ugh it never ends..I have trouble keeping up

  8. SinbadsMom says:

    OMG.

    Glycerin is fed to poultry.

    There’s a glut of glycerin now because it’s a byproduct of biodiesel production, and they’ve been looking for uses for it, and one that’s gotten a lot of attention has been feeding glycerin to poultry.

    Here:

    http://www.biodieselmagazine.c.....amp;page=2

    Excerpt:

    A more recent animal feed trial using glycerin has received national attention. Researchers at the University of Arkansas’ Center of Excellence for Poultry Science recently studied glycerin as a dietary supplement in growing broiler chickens. Poultry nutritionist Park Waldroup initiated the study, which evaluated glycerin in diets fed to broilers of typical market age in litter floor pens.

    The study, which Waldroup cautions is strictly preliminary, showed that as much as 10 percent glycerin could be fed to chicks in battery brooders up to 16 days of age. Battery brooders are brooding boxes with wire floors stacked on top of each other to conserve space.

    Five percent glycerin inclusion in pelleted feed showed no adverse effect on bodyweight, feed intake, feed conversion or mortality. However, 10 percent glycerin inclusion reduced body weight due to reduced feed flow rate. More information on the study can be found at www.biodieselmagazine.com.

    Waldroup and his researchers concluded that glycerin can be used as an energy source for broiler diets. While the results of this study are intriguing, Waldroup cautions they are preliminary and were based on a consistent, clean supply of glycerin.

    So if you have a warning about glycerin, and news that more than 20 million chickens were affected…

    I’m going to post this in the topic about those chickens, too — hope that’s okay. It’s relevant to both.

  9. Lorie says:

    Oh the fun never ends here in the good old USA. This country is falling apart at the seems and all the government can do is worry about cover ups. I really wish I would wake up from this nightmare soon. Bees dying suddenly, pets being poisoned, chickens and pigs being feed tainted food to enter food chain. You know if we went up to someone and started rattling this all off and they are one of the ones who are still clueless anything is going on, they might call the guys in the little white coats to come get us.

  10. Traci says:

    “mal Says:

    May 4th, 2007 at 7:54 pm
    This is very interesting considering the recall in South Africa was inititally blamed on anti-freeze, then changed to contaminated corn gluten.

    What else is being hidden from us??”

    Actually, it was never changed to corn gluten. You are dealing with two seperate instances of contamination.

  11. Traci says:

    “ann Says:

    May 4th, 2007 at 8:27 pm
    Greenies dog and cat treats contains a preservative that is one molecule away from antifreeze. From what I read about this derivative -propyll gallate- it is widely used in pet and human products…”

    Find “propyl gallate” as an ingredient:

    http://www.greenies.com/en_US/products_feline.asp

    It’s not listed.

  12. Karen says:

    Wrong page - it’s in the dog Greenies not the cat.

    http://www.greenies.com/en_US/.....eeding.asp

  13. ann says:

    Thanks for the clarification Karen. I forgot to mention last night that they are both high in veg. protein isolates and glutens.

  14. Lady says:

    In late January, I lost two cats to what i thought was antifreeze poisoning. The deaths were two days apart. The first cat was indoor/outdoor cat. She came home one day and vomitted a little but otherwise appeared fine. I thought it might be a hairball. The next morning she was in excrutiating pain. We rushed her to the vet and she was in kidney failure. The vet came back and said she had crystals in urine characteristic of antifreeze. They gave her the antidote but it didn’t work and i had to euthanize her. This was the first antifreeze case my vet had seen in our area. We live in Southern LA and antifreeze poisoning is rare. I did not see antifreeze leaking from cars anywhere around my house. A day later the other cat showed up and she could hardly move. She died before we could even get her to the vet. I remember switching the food one time to a recalled brand. I asked the vet if it could have been the food but they insist it was anitfreeze. It wouldn’t surprise me in the least. I still think my pets died from the food.

  15. Lady says:

    Interesting, glycerin is used in wet cat food as a humectant.

  16. Patty L says:

    Fake glycerin (to save money, of course) from China contained diethylene glycol, killed thousands! Long article that is very scary. No more imports from China, please, of anything any living being ingests!!!

    http://www.nytimes.com/2007/05.....on.html?hp

  17. John says:

    Isn’t it a coincidence that all of these “fake” and poisonous ingredients come from China originally? The U.S. and other countries need to stop buying any items that originate in CHINA! Interesting too that no drug or food manufacturers even bothered to test the ingredients in the barrel. I guess if it says ‘glycerin’ it must be ‘glycerin’. What fools!!! There should be mandatory testing of ALL ingredients, and there should be criminal (felony) penalties for the lack of doing so!

  18. Gary says:

    It’s long past due when all countries stop any trade with China and bring them to an international tribunal for crimes against humanity.

  19. YaYa says:

    For right now I’d like 3 things DONE.

    1. STOP All manufacturing of pet food {yeah I know tough one huh}

    2. DUMP All existing PET Foods in a Pit and Burn it {possibly a way to get rid of the contaminants? They did that with the bad spinac to it was a Bio- contaminant then}

    3. STOP ALL Imports IN from CHINA NOW!

    For me nothing less would work.

    This has gone Beyond the INSANE Piece-meal Recall work. The Whole shootin’ Match needs to be Scrubbed!

    I think THIS confirms a Cover-up. They’ven been hiding this {part} for weeks. The Public would FREAK!

    And then——Force their Hands to DO Something NOW!

  20. sandi says:

    Question, I mix propyl glycol with i vermec for monthly heartworm protection and prevention in my six dogs.

    Is propyl glycol also a toxin??

    Been doing it for many a year,

    Also we use it to heartworm dogs who are negative awaiting adoption at the shetler

  21. Patty L says:

    For Sandi: I checked some stats about propyl glycol (propylene glycol). its metabolites are not very toxic. it is used commonly as a solvent for various drugs.

  22. Cynthia says:

    If you don’t want to risk being poisoned, AVOID ALL CHEMICAL SUPPLEMENTS AND PROCESSED FOODS.

    Buy only whole foods for your pet and yourself. Buy only US organic meats, vegetables, fruits and grains. Look for organic, whole foods supplements. You and your pets will live a much longer healthier life if you do.

    The Organic Consumers Association is an excellent place to start if you want to learn about organics.
    http://www.organicconsumers.org/
    The OCA deals with crucial issues of food safety, industrial agriculture, genetic engineering, children’s health, corporate accountability, Fair Trade, environmental sustainability and other key topics.

  23. Rhonda says:

    Patty L,

    The 7 page NY Times article blew my mind! I cannot believe that the Chinese gov refused to prosecute or investigate because they don’t regulate stuff that is to be exported (that’s what I got from reading the article). That a tailor with a 9th grade education could make something so illegal (and deadly) and have it shipped around the world and made into cough syrup and kill so many people is insane!
    I’m afraid to take aspirin or vitamins now! Where do the medicines in my cabinet actually come from? China? I’m surprised we aren’t all already dead!

  24. TC says:

    Sinbad’s Mom - thank you so much for posting that blurb re the use of glycerin for poultry.

    It sure tied up some loose ends, didn’t it? Recap - FDA warning re fake glycerin, the NY Times article, the need for the EPA to also be involved in the chicken quarantine, and glycerin used as a feed additive for chickens. At least it is some insight into some of the things they may be freaking out about.

    Dh and I have been discussing this all morning.

  25. TC says:

    I don’t know where else to put it. But I make biscotti. Recently I switched to using a bulk supplier for the anise seed and ever since, whenever I eat it, I bloat badly. Did an experiment this morning having made it without the anise seed. Stomach is normal.

    I went to the website, because they used to show where their stock came from. But maybe a coincidence, but I can’t pull up the anise seed origin. I am tossing it in the trash, as some of their stock was coming from China. I recalled that was the origin for the anise seed. But that was before the recall, and my new awareness of the fact that I need to be looking out for my family, because no one else is.

    This was my fault. The anise was FAR cheaper here than anywere else online. When it came, it had more stemmy material as well. Not buying from a place who does business as China does means I need to not be such a cheapskate.

  26. Kathy Thompson says:

    TC, I think we can grow anise, I wouldn’t eat any more of those seeds either, but you might try planting some to grow your own! If they won’t grow, they’ve probably been irradiated.

    I really think we need to be growing anything we can, we sure can’t count on our gov’t to protect us anymore.

    Can someone remind me how civil disobedience works? I think we can calculate how much of our tax dollar goes to finance FDA (or whatever) and we can refuse to pay that….

  27. Jade says:

    Quick note: be careful that you don’t confuse “one molecule away” with being “the same” as the related substance… remember, methamphetamine can be made by chemically removing the oxygen molecule from pseudoephedrine, if I’m remembering my documentary days accurately. The difference is: while one is safe when used properly (such as in menthol inhalers) and is available for sale in nearly every grocery store and gas station in America, the other is literally one of the most addictive and deadly street drugs in the world.
    You can add a lot of unnecessary stigma to an object or idea that way… though don’t assume I’m standing up for the use of any of the revolting contaminants that are used so haphazardly in production…

    Also worth noting may be the recent incidences of unauthorized genetically-modified crops making their way into the UK- again in from China, or the Netherlands as a by-way for China. I wouldn’t be surprised at all if GM organisms were found in the SA corn gluten, or even in all the melamine-cyanuric-contaminated pet foods…

    Also worth noting are the living conditions of the animals that supposedly “show no adverse affects” when fed up to 10% glycerin in the above noted tests… how the he** do you identify “adverse effects” in any animal kept in a battery brooder??? That’s like testing running shoes on a fat guy in a wheelchair!!!! Who’s the hack running these “research” facilities anyway??

  28. Barbara says:

    Jade,
    WELL PUT!

  29. Cwang619 says:

    A man working at a dog food company in China put Anti-Freeze into the dog food. They had found out today and beheaded him.


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