BHT in Refresh Optive MEGA-3

[scoelicolor]

Hi all,

First off, to anyone reading this I often end up here at DEZ when I am having an especially hard time coping with DES, and maybe you do too, so don't forget that you're not alone and things will get better and we are here for each other!

I have been doing my own personal research on Refresh Optive MEGA-3 PF since I read the back of the box. It contains an inactive ingredient that is a controversial food preservative that has possible links to cancer, even though it has antioxidant properties. My main concern is that the product seems to be mislabeled, and I'm not supposed to use products with preservatives, this says it's PF, but contains a food preservative. So I am going to get to the bottom of this! I like to read journal papers on eye products before using them, and I couldn't find one that said a single thing about this food preservative being used in an eye product. Please let me know if you find one out there.

Knowledge is power so I just wanted to let other users know what I find as I learn things and what it is like to try and get this kind of information.

I personally was getting a lot of relief from this product, but I need to know if it is safe for long term, repeated daily use, so I called the number on the back of the box to find out more. This product says on the front that it is preservative free, but it contains a pretty well known and controversial food preservative used to prevent oil spoilage. SO because I like this product (besides the misleading information) I am making sure it is actually safe for use the way patients with MGD use it. I am a biologist and chemist and I do independent drug discovery and suffer from MGD, and limbal staining from cell death from an unknown source. I suffer daily and I want to use my background to make sure these products are actually safe, and that we are treated as patients and not consumers, and that we have the right information. SO here is what I got from Allergan (the company that makes Refresh products):

Update on Refresh Optive MEGA-3 containing BHT: Tracy from Allergan says she has never been asked about the inactive ingredient 'BHT' and had to escalate my question to higher ups; a little concerning that there is not a straight answer.

She said the product came out in July of last year which is why it says "new" on the box. I asked if Allergan knew about whether it was safe for long term use every 3 hours and how much research was done etc., but didn't get a lot of answers. The short version of what I was told is: a lot of doctors tell their patients to use it....

My main problem with this answer is A: my doctors have me experiment with OTC eye drops until I find one that feels like it helps and put in my file that I use 'artificial tears', not exactly medical advice and B: that my own doctor, whom I've seen for over a year for debilitating pain and limbal cell death (of unknown origin) has made me feel like a guinea pig, even when it comes to FDA approved prescription drugs, like Lotemax: I am supposed to rub 1 drop into each eyelid once daily before bed... my pharmacist never heard of this before... and said since I have a history of responding badly to BAC I shouldn't use it because my eye pressure can remain high for an entire month until my follow up, which is not good. So I never started my Lotemax because the version without BAC isn't covered and is too expensive for me..

My point is that many of the products, procedures etc. our doctors tell us to use for this disease can be experimental and destructive, or OTC, or not really regulated/not considered medical products/more symptom management.
i.e. most of us use OTC drops everyday all day with no end in sight, cool compresses for pain.. and drop overuse is common and ....ultimately patients aren't treated as patients.

Because my last eye appointment went so poorly (my doctor left the room in the middle of examining me, TWICE, forgot to use anesthesia before inserting punctals, (I never had so many reaction tears streaming down my face in my life), he couldn't fit the right punctal plug in and I had to keep my eye open while he jammed it in, also notes from my previous visit were missing, and I waited 5 hours in the waiting room and missed half a day at work, you get the idea... I'm never going to an appointment alone again and you probably shouldn't either) I currently have taken much more initiative in researching drugs/preservatives used for DES into my own hands and have been seeking advice from DEZ (thanks for all your input/feedback/advice/articles!);
So the fact that doctors 'prescribe' this new product to patients doesn't make me feel better. A lot of doctors throw their hands up and don't know what to do with us in the first place. Also, I found from doing my own digging that MEGA-3 is in stage 4 clinical trials, which do not have long term results and seem to rely solely on consumers (us) to report side effects to the FDA, and our doctors are supposed to report our side effects to the FDA as well, not likely for me since my file lists "artificial tears"... So I'm still feeling like a test subject...

So, this might still be a great product IF the BHT is explained to be safe/at safe levels/tested for use in eyes etc.... we'll see! I hope I'm missing something here and it's actually safe to use.

I should get a call back in a couple days with more information. Tracy does not have any information on how much BHT is in the product or why it is there, so far Allergan is not really giving me a lot of confidence in their product. I'll update when I hear more!

See my link on butylated hydroxyl toluene (BHT) use in food. If I come across a link about it's use in eyes I will add a post later on, so far there's nothing.

If you want to call Allergan yourself and let them know your concerns, their number on the box is 800-678-1605

[Rebecca Petris]

Very interesting quest. Going to add just a couple of thoughts on a couple of points.

Update on Refresh Optive MEGA-3 containing BHT: Tracy from Allergan says she has never been asked about the inactive ingredient 'BHT' and had to escalate my question to higher ups; a little concerning that there is not a straight answer.

I'll be pleasantly surprised if you get a meaningful answer from Allergan even after they escalate it. I'd have been dumbfounded if someone had that information ready to hand

She said the product came out in July of last year which is why it says "new" on the box. I asked if Allergan knew about whether it was safe for long term use every 3 hours and how much research was done etc., but didn't get a lot of answers. The short version of what I was told is: a lot of doctors tell their patients to use it....

Just want to mention that OTC drops are not FDA approved based on testing. They are simply registered. They are basically automatically deemed safe to market as a lubricant IF they comply with the FDA's monograph for ophthalmic demulcents, which is basically a list of demulcents (mostly polymers) and the maximum allowable concentrations. You can have up to three. Here's an article on the subject. It's old, but then, if I remember right the monograph is maybe three times as old or more In fact because the monograph is so limiting, you see a lot of things listed in inactive ingredients that may actually be directly related to efficacy, including the oils in the Mega 3 product and the sodium hyaluronate in Oasis drops. Manufacturers list them that way because that's the only way they can comply with the regs. And, because of labeling requirements, they list concentrations of actives, but not of inactives, so for example, if you look at Oasis Tears vs Oasis Tears Plus, the labels are exactly alike. The difference is in the concentration of sodium hyaluronate, but because it's listed as inactive, they can't advertise/play up that fact, though doctors and patients can easily enough figure out in practice that they are different.

Anyway, the point I was coming around to was really just that while Allergan actually does publish a surprising number of studies on their OTC drops (I blogged about this a little recently) there's no particular incentive for anybody to ever do safety studies on them.

our doctors are supposed to report our side effects to the FDA as well,

Theoretically.... but yikes. Adverse event reporting even for medical devices (such as the excimer lasers used in LASIK, or punctal plugs, etc) doesn't happen nearly as often as it should, even when the events are relatively catastrophic. I've never looked for adverse event reports on an OTC drop... though come to think of it I think the mold and the black specs in some gels and ointments a few years back were probably the closest I've heard to anything like that.

Good luck with the question to pin this down, and good for you!!!!!

[Rebecca Petris]

By the way, I am not aware of any other OTC lubricant product with this ingredient on the US market. (Reference list here.) It'll be interesting to hear why it's there.

[scoelicolor]

Thanks for the link Rebecca Petris! This ingredient list is now my go-to reference when I am going to switch drops!

I had no idea that artificial tears had a 3 active ingredients maximum, I was wondering how they could get new drops on the shelf so fast and without FDA testing. Seems like more info on the label could be useful to doctors and patients trying to choose a drop.

I haven't been on DEZ for a bit since my eyes got pretty bad for a while. I have now put my career on hold for a bit to get the most I can from my doctors and to care for my eyes. DED was severely interfering with the quality of my work and life, but on the bright side, I was finally diagnosed, partially! Even though it's not exactly good news, I can understand my disease and make better choices; I have advanced SLK. For the past year I was being told I only had mild dry eye but my eyes were telling me something was wrong. It took well over 12 visits and many on-call doctors to get them to finally notice the staining pattern. I'm glad I didn't let them convince me I was imagining the pain or that it was from overactive nerves. It seems that many eye doctors just do not listen to their dry eye patients. I've read that SLK is rare, but it also under-diagnosed and they don't find it unless they look for it; So for anyone else out there, if your body is telling you something is wrong, don't give up; The squeaky wheel gets the oil.

As far as the BHT, I haven't heard back from the higher ups yet, which I am not super surprised about. I am going to follow up with them again because I really liked Refresh MEGA-3, but haven't used any of my 2 full boxes since I read the label.

I will be sure to write an update as soon as I hear anything from them! In the meantime I will look for journal articles about BHT whether in food or used in eye drops.

[m4shore]

Hi all,

First off, to anyone reading this I often end up here at DEZ when I am having an especially hard time coping with DES, and maybe you do too, so don't forget that you're not alone and things will get better and we are here for each other!

I have been doing my own personal research on Refresh Optive MEGA-3 PF since I read the back of the box. It contains an inactive ingredient that is a controversial food preservative that has possible links to cancer, even though it has antioxidant properties. My main concern is that the product seems to be mislabeled, and I'm not supposed to use products with preservatives, this says it's PF, but contains a food preservative. So I am going to get to the bottom of this! I like to read journal papers on eye products before using them, and I couldn't find one that said a single thing about this food preservative being used in an eye product. Please let me know if you find one out there.

Knowledge is power so I just wanted to let other users know what I find as I learn things and what it is like to try and get this kind of information.

I personally was getting a lot of relief from this product, but I need to know if it is safe for long term, repeated daily use, so I called the number on the back of the box to find out more. This product says on the front that it is preservative free, but it contains a pretty well known and controversial food preservative used to prevent oil spoilage. SO because I like this product (besides the misleading information) I am making sure it is actually safe for use the way patients with MGD use it. I am a biologist and chemist and I do independent drug discovery and suffer from MGD, and limbal staining from cell death from an unknown source. I suffer daily and I want to use my background to make sure these products are actually safe, and that we are treated as patients and not consumers, and that we have the right information. SO here is what I got from Allergan (the company that makes Refresh products):

Update on Refresh Optive MEGA-3 containing BHT: Tracy from Allergan says she has never been asked about the inactive ingredient 'BHT' and had to escalate my question to higher ups; a little concerning that there is not a straight answer.

She said the product came out in July of last year which is why it says "new" on the box. I asked if Allergan knew about whether it was safe for long term use every 3 hours and how much research was done etc., but didn't get a lot of answers. The short version of what I was told is: a lot of doctors tell their patients to use it....

My main problem with this answer is A: my doctors have me experiment with OTC eye drops until I find one that feels like it helps and put in my file that I use 'artificial tears', not exactly medical advice and B: that my own doctor, whom I've seen for over a year for debilitating pain and limbal cell death (of unknown origin) has made me feel like a guinea pig, even when it comes to FDA approved prescription drugs, like Lotemax: I am supposed to rub 1 drop into each eyelid once daily before bed... my pharmacist never heard of this before... and said since I have a history of responding badly to BAC I shouldn't use it because my eye pressure can remain high for an entire month until my follow up, which is not good. So I never started my Lotemax because the version without BAC isn't covered and is too expensive for me..

My point is that many of the products, procedures etc. our doctors tell us to use for this disease can be experimental and destructive, or OTC, or not really regulated/not considered medical products/more symptom management.
i.e. most of us use OTC drops everyday all day with no end in sight, cool compresses for pain.. and drop overuse is common and ....ultimately patients aren't treated as patients.

Because my last eye appointment went so poorly (my doctor left the room in the middle of examining me, TWICE, forgot to use anesthesia before inserting punctals, (I never had so many reaction tears streaming down my face in my life), he couldn't fit the right punctal plug in and I had to keep my eye open while he jammed it in, also notes from my previous visit were missing, and I waited 5 hours in the waiting room and missed half a day at work, you get the idea... I'm never going to an appointment alone again and you probably shouldn't either) I currently have taken much more initiative in researching drugs/preservatives used for DES into my own hands and have been seeking advice from DEZ (thanks for all your input/feedback/advice/articles!);
So the fact that doctors 'prescribe' this new product to patients doesn't make me feel better. A lot of doctors throw their hands up and don't know what to do with us in the first place. Also, I found from doing my own digging that MEGA-3 is in stage 4 clinical trials, which do not have long term results and seem to rely solely on consumers (us) to report side effects to the FDA, and our doctors are supposed to report our side effects to the FDA as well, not likely for me since my file lists "artificial tears"... So I'm still feeling like a test subject...

So, this might still be a great product IF the BHT is explained to be safe/at safe levels/tested for use in eyes etc.... we'll see! I hope I'm missing something here and it's actually safe to use.

I should get a call back in a couple days with more information. Tracy does not have any information on how much BHT is in the product or why it is there, so far Allergan is not really giving me a lot of confidence in their product. I'll update when I hear more!

See my link on butylated hydroxyl toluene (BHT) use in food. If I come across a link about it's use in eyes I will add a post later on, so far there's nothing.

If you want to call Allergan yourself and let them know your concerns, their number on the box is 800-678-1605

Any updates on this?

[scoelicolor]

Sorry I haven't checked in for a while, if I'm being honest, I had a period of pretty severe depression stemming from my SLK; but I am successfully climbing out of it.

I still have not heard back from anyone at Allergan through e-mail or by phone. I'm going to put another call in to find out if the information was directed correctly. I have not used the MEGA-3 drops since I read that they have BHT and I still have the 2 full boxes sitting in my eye care drawer. I will update this as soon as I get an answer out of them!

In the meantime I have only been using Refresh Liqui-gel eye drops, as needed (or to rinse out my eyes after crying) for the past few months. I do blinking exercises and yawning to hopefully stimulate my lacrimal glands (yawning was not something I was not directed to do, but it makes me produce more tears). I stopped ALL heated compresses/gland expression, and a lot of the debilitating pain behind my eyes went away completely. I still have burning, stinging, dryness etc, but the most debilitating aching pain is gone. My current Dr. thinks I was overstimulating my eyes by doing too much, and I think he was right. By no means are things fully better. I am still very limited in what I can do that involves wind or AC and I need some form of moisture glasses most of the time, but I have some of my freedom back and I can keep my eyes open much longer. Of the many, many eye drops I have tried, the Liqui-gel are the best so far, and my days are extending longer. So, hopefully I can get involved on here a lot more again.

For anyone who may be interested, and may be suffering from similar deep depression due to eye health, I want to share what has helped me so that maybe it can help you too. (Aside from a good therapist) I found that listening to audio-books through Scribd is great and cheap, or there are also some free audio-books through online libraries if you have a membership. I also started asking for audio-book gift-cards for Christmas and birthdays and got a few months worth!

One of the books that helped me a lot was actually about chronic illness, and I didn't think of myself as someone having a chronic illness, but DED and SLK definitely are! Many audio-books and Podcasts don't talk specifically about DED, but they are incredibly helpful if you look at the big picture. Personally, I was fighting against my illness and used so much energy on denying that it existed and wishing it away, it actually really drained me. Once I accepted that I had SLK and the fact that it might never go away for me, it got easier. And even if this disease doesn't go away, I can learn to manage it and value good days much more because the hard days have taught me how important it is to appreciate anything good I am given. I think things really can get easier for anyone else reading this too, so don't give up!

If you haven't already, I recommend checking out "Surviving and Thriving with an Invisible Chronic Illness" by Ilana Jacqueline. It helped me a lot about learning how and when to talk to people about my illness.

I also started meditating with the help of free apps on my phone and by using guided meditations on Youtube; There's a million and they helped with my pain, sleep issues and so much more.

I also learned that podcasts are fantastic because I can download them for free and listen to them anywhere, I don't need to use my eyes and there are topics about almost anything under the sun. I have been listening to "This is Not What I Ordered" Which talks about chronic illness, but it a way that will make you notice all of the unexpected positive outcomes that can come from living with a chronic illness.

And lastly, you may have already heard about "Spoon Theory", but if not check it out. I love the simplicity of this and it stuck with me and made me realize how important prioritizing is when you have very limited time/energy for daily activities due to chronic illness. (attached is the PDF)

I really wish I could be on here more often, but I can only spend so much time on the computer before my eyes start to go downhill (so I am really excited to see that there are audio pages being added!!!)

Sorry again for the time away from DEZ, and to get off topic of the BHT. I hope these resources can help you all in some way like they did for me and I will update with any info on the MEGA-3
drops as soon as I get any info from them!