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Not safe enough for cows...but women?
Readers of the Milex website (1) will still find a proclamation there that Milex is a quality driven “private company founded in 1937.” In reality, on February 3, 2004 the publicly traded corporation, Cooper Surgical, bought Milex for $26 million dollars in cash. With this purchase came a history of regulatory problems with one of Milex’s most widely distributed products, Trimo-San Vaginal Jelly.
Trimo-San is marketed as “A Unique Vaginal Product” and a 4-ounce tube sealed in plastic and distributed along with every Milex pessary to prolapsed women throughout the developed world. Trimo-San was reformulated in 1977 to include its primary active ingredient and has remained unchanged since that time.
That active ingredient, 8-hydroxyquinoline sulfate, is one of a family of coal tar derivatives first manufactured in 1899. The compounds from which 8-hydroxyquinoline sulfate is made are known as quinolines and isoquinolines, and are similar in chemical structure to benzene rings.
8-Hydroxyquinoline sulfate is claimed to have antiseptic properties and has been used throughout the past century as a topical antiseptic in livestock and has historically been used in the production of human food, medicine and cosmetics. However, there are currently no FDA approved over the counter (OTC) uses for 8-hydroxyquinoline sulfate. The historically approved uses as a topical skin protectant and antifungal have been withdrawn and are now classified as “Category II” or “Not generally recognized as safe and effective or misbranded.” Only one prescription drug listing exists for human use, which is the injectable form compounded with Indium 111 for radiologic studies.
In 1992, the Cosmetic Ingredient Review Expert Panel reviewed the safety of 8-hydroxyquinoline sulfate for use as a fungicide and bactericide in cosmetic formulations in concentrations less than or equal to 1.0 %. The panel reported that available carcinogenicity data were insufficient to support a conclusion on the safety of this chemical.
Although labeled a “mutagen” by the National Institute for Occupational Safety and Health because it is known to cause genetic damage in human blood cells (2), 8-hydroxyquinoline sulfate is not generally reported as a carcinogen. The International Agency for Research on Cancer states this is because the few studies that have been carried out on 8-hydroxyquinoline sulfate have proven to be “of limited value.” (3)
A 2001 document on the effects of 8-hydroxyquinoline sulfate on livestock prepared for the USDA by the Organic Materials Review Institute states that “Although it is not generally reported as a carcinogen or teratogen, a test of the food additive formerly used as cheese preservative (8-hydroxyquinoline sulfate) found tumors in the bladder, brain, and uteri of rats and mice when administered intervaginally.” (4)
The FDA issued a warning letter to Milex on November 24, 1999 citing several regulatory breeches involving the manufacture of their product. Central to these citations was a review of the labeling of Trimo-San:
“Trimo-San Vaginal Jelly is labeled for use three times daily during the first week of treatment and two times a week thereafter. The labeling does not include any time limit when the product should be used. Based on the intended uses cited above, this product is a drug within Section 201(g) of the Act. We do not have any information which shows that your product or similarly formulated and labeled OTC products were marketed as OTC drugs in the United States before December 4, 1975. We do not know of any substantial scientific evidence that demonstrates that this product is generally recognized as safe and effective for its intended uses.”
No subsequent changes were made in either the formulation or labeling of Trimo-San and in June of 2004 Cooper Surgical petitioned the FDA to include 8-hydroxyquinoline sulfate in the OTC drug monograph for vaginal lubricants and moisturizers. A review of current FDA approved OTC drugs and their active ingredients confirm that Cooper’s request for classification remains denied.
While the 19th century gave rise to the industrial revolution, there was little consciousness into such processes as carcinogenicity. It was during the later half of the 20th century that modern societies began to understand the cause and effect relationship between environmental substances such as quinolines and human cancers. How shocking that in the year 2006 a substance so questionable as to be unregulated by the United States government for topical use on livestock is permitted to exist as the only widely distributed vaginal lubricant prescribed to prolapsed women in unlimited doses!
(1) http://www.milexproducts.com
(2) National Institute for Occupational Safety and Health 1997. Registry of Toxic Effects of Chemical Substances:
http://www.cdc.gov/niosh/rtecs/vc7e09a0.html.
(3) International Agency for Research on Cancer. http://www-cie.iarc.fr/htdocs/monographs/vol13/hydroxyquinoline8.html
(4) OMRI NOSB Tap Materials Database:
http://www.ams.usda.gov/nop/NationalList/ TAPReviews/Hydroxyquinoline.pdf
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Regardless of what we hear,
Regardless of what we hear, i'm always researching what my baby is prescribed and as much as i dont like giving him drugs until he's older if he's sick he'll have to take them. I eat healthy exercise etc and do fine every year no flu no colds etc. These docs dont have a clue as to what their prescribing the doctors get told by drug companies what the drugs do they prescribe them sold. It amazes me more people aren't in drug rehab on the account of the stuff they write scripts for.
Lubricants
Hi Greenone
Just wondering if a bacteriostat is a good thing to be using in your vagina in the longer term?? I can see that it is probably good surgery hygiene for the doctors' surgery, but would be wary of its potential resistance effect on vaginal microflora when I am the only one using it.
The good bacteria are are critical for vaginal health, but wouldn't a bacteriostat discourage them, and also potentially build up resistance in any bad bacteria that find their way in there, eg e. coli? I think I would prefer to use one that had as little effect as possible on my microflora, eg standard KY gel or something similar.
Cheers
Louise
parabens and pessaries
Hi Greenone,
Thanks so much for joining this revolution in women's health!
Type "parabens" into the search engine on the left of the screen and you should receive some valuable information.
I would take pessaries over surgery and posture over pessaries. But if you can find a comfortable pessary that reduces your symptoms, you may be able to wear it for years with no exacerbation of your condition.
:-) Christine
Trimo-San and other lubricants
Hi Christine,
I have just recently joined, and would like to thank you for your comments on Trimo-San. I used it as a pessary lubricant for 4 years or more. I experienced intense vaginal irritation which I questioned various Doctors about. Some suggested it was meno pausal hormones, other suggested using an anti itching cream.
My present Doctor, who really wants me to have surgery for a prolapsed bladder, suggested I just use Lubricating Jelly. She uses it in her office for rectal and vaginal exams. It is put out by Health Care Plus and is a Bacteriostat. The preservatives listed in it are Methyl paraben and propyl paraben. There are no other ingredients listed.
I have been using it for over one year now. I have had no vaginal irritation with it. My last period was eight months ago, so I'm not sure if the irritation was indeed caused by "hormones" as I approach meno pause.
What is your opinion of using this lubricant for a pessary wearer? What do think of my Doctor's opinion that a pessary is a foreign object and not good for me? She has suggested surgery several times but your comments have kept me from having this done.
Thank you.
Vaginal lubricant / Better sex
Hi Rosemary
There are a few topics scattered through the Lifestyle forum that touch on lubricants. I am about to put a new topic re 'better sex with prolapse'in the Lifestyle forum so we can get all those sex-type questions into one space.
Cheers
Louise
Trimosan and Cancer
Thanks Christine for your detailed info on Trimosan beeing a possible carcinogen. I have been treated for non-Hodgkin's Lymphoma since I started using Trimosan. I am serious about investigating whether the Trimosan is the cause of my cancer. Could you give me suggestions about how to go about doing this? Should I contact someone in the government? or a lawyer who specializes in these cases? Does anyone have any referrals? My email is: mary.ellen@sbcglobal.net (if anyone wants to send it privately) Thanks.
Safe for cows but not for women
I didn't post before, because I wasn't really surprised. Very annoyed, but not surprised. I have no reason to believe that a pharmaceutical company promoting its human health product would mention to a doctor facts that are of veterinary interest, especially if the doctor doesn't ask "Is it safe for cows?" What doctor would be interested unless she was planning to use it herself. And it would be a pretty random question to ask a rep.
And I wasn't surprised that the USA national regulator failed to notice the discrepancy, as their job is so big. What's one little discrepancy? =:-O Call me a cynic if you like. I think maybe I am just getting wiser after sorting out family health problems all these years, and discovering that ultimately I have to be the one to decide whether a treatment or drug is OK for me or my family members, not the doctor who is basically just promoting others' products when he says, this or that cream is best. That is not meant as a dig against doctors. It is just that a lot of the detailed information about drugs is not displayed up front, and I think many doctors are swayed by promotion, rather than doing an audit on every drug they are asked to prescribe. They are doctors, not auditors, and there has to be a degreee of trust in all this. Doctors are a great place to start, but I don't think we should take their opinion as the final word.
God gave us freedom to choose and a brain to use, and now, thanks to Christine, I won't be using Trimosan.
Cheers
Louise
unbelievable
This astounds me and really makes me want to research every single thing my doc and my baby's doc prescribes. I had an OB appt. last week and saw Trimo-san sitting on the counter. Clearly it's still used. And this is at UCSF! I wonder when/if this research will make it to the medical world.
Ann
Hi, I love the site. What is
Hi, I love the site. What is a good vaginal lubricant? Also to all the posture works. I have your book and video and my body knows when
I am not using the posture. It's been about a year doing the exercise and learning to be mindful of my body. I stopped eating meat in sept. my family and friends think I'm nuts but I feel good and that's what matters. Looking foward to your new video.
Thanks
Rosemary
Trimo-san
Wow, and they said this would give the proper PH balance. Good thing I couldn't find it after I ran out. I did notice that I had a funny discharge, kind of like cottage cheese, when I used that and not with regular lubricants. My doctor never said anything about the discharge, I didn't have an infection.
Thank you so much for being brave and telling the truth. You are such an inspiration and comfort to us.