composing letter to the FDA: I am going... - Allergic to Glycols

Allergic to Glycols

composing letter to the FDA

gothchiq profile image
25 Replies

I am going to compile a list of peer reviewed journal articles documenting glycol allergy and send them with a letter to the FDA. Why are glycols still on the GRAS list when 6 out of every 100 people are allergic? (this stat is from the Journal of Allergy and Immunology.) Why must we risk our lives any time we need a medical procedure or a prescription? If an infection must be immediately treated, why must we waste precious time attempting to scrounge for an antibiotic that isn't poison to us? This isn't right. Drug companies are pumping more and more glycols into medicines of all types. Every year it's harder to obtain safe medication. Other allergies, like peanuts, have been taken seriously, yet glycol allergy is blithely ignored. I can't sit by and allow this without at least making an attempt to redress it. There is strength in numbers. I encourage others to do the same.

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gothchiq
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25 Replies
Kerry_McIntyre profile image
Kerry_McIntyre

I agree with your sentiments wholeheartedly about the unfairness of so many medications being unavailable to those of us who are allergic to the glycols. I have also gone the route of trying to get my views heeded by the CDC to no avail. As a result of my frustration, and lack of alternatives, I have completely changed my view of our conventional petroleum-based pharmaceutial/medical health care model. I now use integrative/functional medical practitioners with great success. Their model is based on the knowledge that a strong immune system will keep us healthy. Living a good healthy life style vs. a cure for sickness life style makes much more sense to me. When I do need "medications", other than basic vitamin and mineral supplements, I opt for herbal and food-based "medicines". As a result, I am much healthier than I was and much more in control of my own destiny.

gothchiq profile image
gothchiq in reply toKerry_McIntyre

I wish I could afford that too. Insurance only pays for "regular" doctors and I'm pretty broke. It's a trap if you ask me. I don't really expect to have great success but I feel like if many people try, eventually someone will have to wake up and smell the coffee. People shouldn't have to fear death from anaphylaxis if they end up in the ER.

Kerry_McIntyre profile image
Kerry_McIntyre in reply togothchiq

You are so right---it is an awful trap. It's such a tremendous injustice for insurances not to see the benefit of holistic medicine. IMO they are all bought off by the pharmaceutical companies which are extremely powerful. In the meantime, we all suffer through their tyrannical rule. I applaud your noble efforts and wish you the best of luck. I believe the people are starting to wake up to the inadequacies of our traditional medical system, especially with regard to the harm being done by vaccines and many other pharmaceutical drugs.

gothchiq profile image
gothchiq in reply toKerry_McIntyre

I'm not anti vaccines in general but I do think they should have a care as to what the ingredients are. Probably all I should say about that as I don't want to start a debate. I bought the Sugar Busters book as a way to get my blood sugar controlled (it was moving into prediabetes) rather than have to futilely try to find yet another medicine without glycol. Anything that goes wrong, the doctor goes straight to "eAt m0Ar P1lLs!" No. I do not want to do that. I want to minimize the RX that I must take. I got off antidepressants after 20 years (because now they are ALL glycol saturated) and good lord, the withdrawal symptoms I have had. Hot flashes, deformed fingernails, odd mood swings and sleep disturbances. I'm using ashwagandha to even things out instead, but they do not tell you that once you take these meds, there's a price to pay, and they don't say there are other things you can at least try before resorting to drastic chemical measures. I had to quit them cold turkey also due to the formulation change. That was terrible. It's a lot of work doing research on my own and talking to other people on the same path because the cost of holistic practitioners and/or compounding pharmacies is not currently accessible to me. :/

findtheanswernow profile image
findtheanswernow in reply togothchiq

My son takes an anti-depressant. I have done so much research to find one that does not include PG. according to the label, it (venlafaxine) says it does NOT have any. But he constantly has a reddish, blotchy hue to his face. The redness becomes MUCH worse if his body temperature rises thru exercise or a hot day outside. He never had this red face problem before he took anti-depressants. I’m convinced the Rx is causing it, even though no PG is listed by manufacturer. Can you share more about the “red face” you experienced?

gothchiq profile image
gothchiq in reply tofindtheanswernow

Look for polyethylene glycol, PEG, or hypromellose on the label. If that still doesn't reveal it, then if you are willing to either type out all the ingredients or link me to a listing of ingredients of whatever brand/generic he is using, I will help you check.

What happens to me is on first exposure a huge mess of acne comes up. Another exposure adds itchy hives. A third or subsequent exposure adds severe pain, itching and redness that looks like a nasty sunburn, in addition to the huge cystic acne. It takes about a month for this to clear.

findtheanswernow profile image
findtheanswernow in reply togothchiq

SUNBURN is the word! He looks like he has the world's worst, most painful sunburn ever. His skin is hot to the touch. Takes about a week to clear up.

gothchiq profile image
gothchiq in reply tofindtheanswernow

And if we find no glycols, try calling the pharmacist to see if this medication has vascular effects, such as blood vessel dilation, that would affect his face directly.

gothchiq profile image
gothchiq in reply tofindtheanswernow

Okay so I googled side effects on this med. Vasodilation is listed, and that sounds like the problem you've reported. I can still help you check for glycols if you can tell me the brand/manufacturer of his meds.

findtheanswernow profile image
findtheanswernow in reply togothchiq

Venlafaxine 75mg 3x per day. Manufacturer: Zydus

gothchiq profile image
gothchiq in reply tofindtheanswernow

All right. Let's see here.

SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

GELATIN (UNII: 2G86QN327L)

HYPROMELLOSES (UNII: 3NXW29V3WO)

CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI)

SODIUM LAURYL SULFATE (UNII: 368GB5141J)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Now, see that word "hypromellose"? That compound is a combination of propylene glycol and wood cellulose. I'm sorry... this pill is no good for your son if he is allergic to glycols.

Why on God's green earth must they stuff glycols into everything and conceal them with sneaky language?

findtheanswernow profile image
findtheanswernow in reply togothchiq

You are providing the most amazing information for me - I can't thank you enough! Although I had NO idea about Hypromellose, I did switch him off the Venlafaxine extended release to a non extended release table, because I know most ER versions contain PG. Even switching him to tablet formulation, he is still having horrible red face responses. His face gets so red it's frightening. Once he cools off, it calms down slightly (not quite so frightening), but remains ugly for about a week.

Here's a link to the table formulation. Do you see anything suspect in it?

dailymed.nlm.nih.gov/dailym...

gothchiq profile image
gothchiq in reply tofindtheanswernow

Everything there looks fine. It has the same inert ingredients as the estradiol I take for menopause. While "sodium starch glycolate" sounds suspicious, I looked it up and it's not actually a glycol. It's just a potato extract.

Vasodilation is still a side effect of venlafaxine, so if his face continues to redden without glycols, that's the reason. I would talk to the doctor and pharmacist about it, and of course ask your son if it is physically painful.

gothchiq profile image
gothchiq in reply tofindtheanswernow

Sodium starch glycolate type A potato is the sodium salt of carboxymethyl ether of starch from potato origin. Starch glycolates are also of rice, wheat or corn origin. It is a white to off-white, tasteless, odorless, relatively free-flowing powder.

Sodium starch glycolate is used as a pharmaceutical grade dissolution excipient for tablets and capsules. Sodium starch glycolate absorbs water rapidly, resulting in swelling which leads to rapid disintegration of tablets and granules. It is used as a disintegrant, a suspending agent and as a gelling agent. Without a disintegrant, tablets may not dissolve appropriately and may effect the amount of active ingredient absorbed, thereby decreasing effectiveness.[1] [2]

Does your son have any food allergies? The venlafaxine you posted has the potato starch product in it. The potato is in the nightshade family. Some people are allergic to all plants in this classification. Tomatoes belong to that family of plants also.

findtheanswernow profile image
findtheanswernow in reply togothchiq

He has a plethora of food sensitivities that we've been able to identify, no actual allergies. We know he's very sensitive to dairy and corn. We avoid gluten, just because it's known to be inflammatory. No issues with potatoes that I've ever noticed. (We went through an elimination diet to figure this out).

His food sensitivities were causing terrible eczema. Once we figured that out, his skin miraculously cleared up. However, when we started on antidepressants, the red faceting started happening. Doctors keep trying to tell me it's just more eczema, but I know it's not. Very different.

gothchiq profile image
gothchiq in reply tofindtheanswernow

I think we're down to the vasodilation side effect. Blargh. That sounds difficult and not like something that could be ignored on a daily basis.

Lynne0762 profile image
Lynne0762 in reply tofindtheanswernow

I have to comment here....how about St. Johns Wart? I don't know if kids can take it or not but it's a natural antidepressant. Not sure of it's ingredients either. :(

gothchiq profile image
gothchiq in reply tofindtheanswernow

Here you can see what hypromellose exactly is. I stopped copying at the table level as that's really only useful for chemists.

Hypromellose

Cellulose, 2-hydroxypropyl methyl ether.

Cellulose hydroxypropyl methyl ether [9004-65-3].

» Hypromellose is a propylene glycol ether of methylcellulose. When dried at

105 for 2 hours, it contains methoxy (–OCH3) and hydroxypropoxy (–

OCH2CHOHCH3) groups conforming to the limits for the types of Hypromellose

(hydroxypropyl methylcellulose) set forth in the accompanying table.

Lynne0762 profile image
Lynne0762 in reply togothchiq

Where did you find this info? I need it for Losartan. My BP is high and goes higher so I need the meds. Hibiscus Tea helps but is not something I can count on working all the time. I have aneurysms so really need to know my BP is normal. Thanks.

findtheanswernow profile image
findtheanswernow in reply toLynne0762

Are you trying to find list of ingredients in what you take? Best place to look is here. List every Medication by every manufacturer. dailymed.nlm.nih.gov/dailym...

gothchiq profile image
gothchiq in reply tofindtheanswernow

Thanks. I'll bookmark it.

gothchiq profile image
gothchiq

This is a progress report. I have so far compiled two pages worth of citations to peer-reviewed articles and studies in medical journals to show how dangerous it is to ignore glycol allergy.

Lynne0762 profile image
Lynne0762

I was part of a group on Yahoo called MIRALAX. Mostly it was parents advocating for their children given PEG for constipation. Kids have that! A more natural med would be so much better of course but most parents do get their advise from pediatricians...I did. ANYway they had us sign letters and the letters were sent to the FDA but were ignored. Keep TRYING though and we'll sign. I don't know what happened to that yahoo group. There are power in numbers so I'll try once again to find that group of people. Their poor kids had the same symptoms (and more) that I did (burning bladder). Poor babies! BTW I called the FDA pharmacist and asked about Losartan without PEG. They referred me to write to Freedom of Information Act. !!!! She didn't speak English well so maybe it was a misunderstanding. She did say there are thousands of makers of a drug...we can't check each one. I told her there should be a query to search for that! That's when she referred me to the Freedom of Info act. hhhmph! I'll sign if you want.

gothchiq profile image
gothchiq in reply toLynne0762

You're more than welcome to use my letter as a template and send to them as well. I honestly think they will only do anything when people bring class action lawsuits, and I am all kinds of broke and in no position to do that. :( As to the ... irregularity issue, I use Dulcolax soft chews. These don't contain glycols and are the only thing I've found, other than the much harsher magnesium citrate liquid that I use for cleanout before colonoscopies.

gothchiq profile image
gothchiq

If enough people make a racket, particularly if there are class action lawsuits, they will eventually be forced to care. One does not achieve success by giving up.

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