PAXLOVID

[kels35]

Does anyone know if the drug PAXLOVID is gluten free or where I could locate this information? I don't want to make my COVID symptoms worse with gluten intake! 

[RMJ]

2 hours ago, kels35 said:

Does anyone know if the drug PAXLOVID is gluten free or where I could locate this information? I don't want to make my COVID symptoms worse with gluten intake! 

Ingredients are listed at the bottom of page 1.

Paxlovid labeling

[Scott Adams]

You can also search here to find ingredients used in medications:
https://dailymed.nlm.nih.gov/dailymed/ 

[SillyMe83]

I'd be really interested in discussing this further. I just tested positive for C-19 on Wed and started Paxlovid yesterday. Let me tell you, my stomach wanted NOTHING to do with that medication. I got 4 doses in and the last one came up with a vengeance! I have stopped taking it and maybe I'm just intolerant of those medications but I wonder if there's something hidden in it because I feel very much like I got glutened. 👎

[trents]

I'm a celiac, though not a really sensitive one. I got COVID back this summer and took the Paxlovid without any gut disapproval that I noticed. However, I was one of the 18% or so of people who got the COVID rebound after taking the antiviral drug.

[RMJ]

These are some of the possible side effects of Paxlovid from the labeling information.

Other possible side effects include:

o altered sense of taste
o diarrhea
o high blood pressure
o muscle aches
o abdominal pain
o nausea
o feeling generally unwell

[LisaGayle]

On 11/12/2022 at 2:06 AM, SillyMe83 said:

I'd be really interested in discussing this further. I just tested positive for C-19 on Wed and started Paxlovid yesterday. Let me tell you, my stomach wanted NOTHING to do with that medication. I got 4 doses in and the last one came up with a vengeance! I have stopped taking it and maybe I'm just intolerant of those medications but I wonder if there's something hidden in it because I feel very much like I got glutened. 👎

You did. The manufacturer cannot guarantee that Paxlovid is gluten-free. I took one dose and had to stop.

It's past time for Congress to require manufacturers to create gluten-free pharmaceuticals. Or at least put allergen labels on them! I'm so tired of my doctors telling me to ask my pharmacists who tell me to call the manufacturer. When you're sick, you don't have the energy for that nonsense!

[Scott Adams]

So the manufacturer is only doing a CYA by not guaranteeing that Paxlovid isn't gluten-free, but it is:

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7bdddfba-bd31-44cb-ba9e-23a4e17a4691

Quote

INACTIVE INGREDIENTS
Ingredient Name
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)     
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)     
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)     
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)     
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)     
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)     
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)     
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)     
FERRIC OXIDE RED (UNII: 1K09F3G675)

It is highly unlikely that there would be any cross-contamination in an FDA inspected drug manufacturing facility.

I suspect your reaction was due to the many side-effects that the drug can have, or the "lactose" ingredient.

[LisaGayle]

11 minutes ago, Scott Adams said:

So the manufacturer is only doing a CYA by not guaranteeing that Paxlovid isn't gluten-free, but it is:

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7bdddfba-bd31-44cb-ba9e-23a4e17a4691

It is highly unlikely that there would be any cross-contamination in an FDA inspected drug manufacturing facility.

I suspect your reaction was due to the many side-effects that the drug can have, or the "lactose" ingredient.

It's my understanding that Pfizer cannot guarantee that its suppliers provided gluten-free fillers.

[Scott Adams]

This is the correct list of inactive ingredients, and none of them contain gluten. Where did you hear this info about Pfizer?

[LisaGayle]

7 minutes ago, Scott Adams said:

This is the correct list of inactive ingredients, and none of them contain gluten. Where did you hear this info about Pfizer?

It was here: https://www.glutenfreesociety.org/is-there-gluten-in-my-medication/

I should tell you I also had a reaction to Paxlovid that felt like gluten.

[Scott Adams]

Paxlovid would only be prescribed in high risk groups in those with covid, and if so, it would be best to take it, as the negative risks associated with a bad case would far outweigh that of a celiac reaction. 

Again, all medicines are made in FDA inspected and licensed facilities, so cross contamination is very unlikely. I don't trust info on that site, as Dr. Peter Osborne is a chiropractor and not an MD, and he also makes a lot of other wild claims about what celiacs should not eat, not to mention that his site is geared to sell you his products. 

[LisaGayle]

14 minutes ago, Scott Adams said:

Paxlovid would only be prescribed in high risk groups in those with covid, and if so, it would be best to take it, as the negative risks associated with a bad case would far outweigh that of a celiac reaction. 

Again, all medicines are made in FDA inspected and licensed facilities, so cross contamination is very unlikely. I don't trust info on that site, as Dr. Peter Osborne is a chiropractor and not an MD, and he also makes a lot of other wild claims about what celiacs should not eat, not to mention that his site is geared to sell you his products. 

Of course it would be "best to take it." Do you really think people who have a gluten reaction stop taking it because it's mildly annoying? Who are you, exactly? Because it certainly seems to me that you have no idea what a celiac reaction is like, or what FIVE DAYS of gluten supplementation will do to the gut and digestion of a person with celiac disease. If Pfizer itself is admitting that there may be supplier contamination, maybe they need to reexamine their suppliers.

[Scott Adams]

I think my signature block says who I am, but so far you did not answer my question regarding your claim here:

Quote

It's my understanding that Pfizer cannot guarantee that its suppliers provided gluten-free fillers.

This is not the place to scare people from taking medications made by Pfizer or any other company, and if you make such a claim please provide a link to support it. I've provided a link in this thread to a USA Government web site that maintains a database of all drug ingredients per manufacturer, and no gluten is used to make Paxlovid:

https://dailymed.nlm.nih.gov/dailymed/ 

[Scott Adams]

24 minutes ago, LisaGayle said:

Do you really think people who have a gluten reaction stop taking it because it's mildly annoying? 

Did you not read through this thread? That is exactly what @SillyMe83 reported:

 

[trents]

1 hour ago, LisaGayle said:

Of course it would be "best to take it." Do you really think people who have a gluten reaction stop taking it because it's mildly annoying? Who are you, exactly? Because it certainly seems to me that you have no idea what a celiac reaction is like, or what FIVE DAYS of gluten supplementation will do to the gut and digestion of a person with celiac disease. If Pfizer itself is admitting that there may be supplier contamination, maybe they need to reexamine their suppliers.

LisaGayle, I don't understand your vitriolic reaction. Scott was just providing information and an opinion. And regarding Dr. Peter Osborne, Scott is correct. Osborne is speaking to issues he is not qualified as a chiropractor to address with any authority. We have had forum members in the past who were promoting some questionable ideas based on Osborne's statements.

[LisaGayle]

Hello, everyone. I called Pfizer this morning (2/13/23). While Paxovid does not have "gluten-containing ingredients," they cannot guarantee that there is no cross-contamination by their suppliers. I filed a Drug Safety Report, telling them when I took Paxlovid, for how long, and the severity of my reaction.

If you have experienced a gluten reaction, I encourage you to call Pfizer at 1-800-438-1985 and file a Drug Safety Report. The only way we will obtain drugs free of gluten, corn, soy and lactose is if we share our experience and ask them for allergen-free drugs.

Thank you! : )

[trents]

19 minutes ago, LisaGayle said:

Hello, everyone. I called Pfizer this morning (2/13/23). While Paxovid does not have "gluten-containing ingredients," they cannot guarantee that there is no cross-contamination by their suppliers. I filed a Drug Safety Report, telling them when I took Paxlovid, for how long, and the severity of my reaction.

If you have experienced a gluten reaction, I encourage you to call Pfizer at 1-800-438-1985 and file a Drug Safety Report. The only way we will obtain drugs free of gluten, corn, soy and lactose is if we share our experience and ask them for allergen-free drugs.

Thank you! : )

As long as any of those allergens you list are not intentional ingredients I don't believe they would be required to list them as allergens under existing laws as long as they are not claiming to be "gluten free", "corn free", "soy free", "dairy free", ect. And I'm not sure the same allergen labeling regulations that exist for food apply to meds anyway. They have to use something as filler in pills and no matter what they use there will be someone out there that is allergic to it.

Edited February 13, 2023 by trents

[LisaGayle]

20 minutes ago, trents said:

As long as any of those allergens you list are not intentional ingredients I don't believe they would be required to list them as allergens under existing laws as long as they are not claiming to be "gluten free", "corn free", "soy free", "dairy free", ect. And I'm not sure the same allergen labeling regulations that exist for food apply to meds anyway. They have to use something as filler in pills and no matter what they use there will be someone out there that is allergic to it.

Hm. Maybe it's time to change the law.

[trents]

15 minutes ago, LisaGayle said:

Hm. Maybe it's time to change the law.

Perhaps. But to test meds for incidental amounts of all those allergens would be expensive and drive the price of meds up.

[LisaGayle]

10 minutes ago, trents said:

Perhaps. But to test meds for incidental amounts of all those allergens would be expensive and drive the price of meds up.

For those of us who can't take medicine because of cross-contamination, having allergen-free medicine would be a godsend.

It's interesting to me that you keep arguing against the necessity of allergen-free medicine. Makes me think you've never really had a gluten reaction. Or you're a pharma lobbyist.

[trents]

46 minutes ago, LisaGayle said:

For those of us who can't take medicine because of cross-contamination, having allergen-free medicine would be a godsend.

It's interesting to me that you keep arguing against the necessity of allergen-free medicine. Makes me think you've never really had a gluten reaction. Or you're a pharma lobbyist.

You would have done well to keep these thoughts to yourself as neither of them are true. You evidence a proclivity to lash out at others in this thread when they don't agree with you.

For your information, the FDA-established limit for legitimately advertising a food item is 20ppm. That is based on a total gluten intake of 10mg per day: https://www.glutenfreedietitian.com/how-much-gluten-is-20-parts-per-million/

Here is a visual picture of 10mg of gluten as you might find it in toast crumbs: https://www.glutenfreewatchdog.org/news/what-does-10-mg-of-gluten-look-like/

Does the standard need to be lowered? Perhaps. Apparently, it does not work for the more sensitive subset of the celiac community. But it works for the overwhelming majority. To tighten the standards excessively would likely drive up the costs of already very expensive gluten free foods to an unreasonable level just to accommodate the needs of a relatively small number of people in the celiac/gluten sensitive community and you would likely see the same effect with meds. Is that fair to the celiac community as a whole?

We do understand your frustration but it's important to grasp the big picture.

 

[LisaGayle]

4 minutes ago, trents said:

You would have done well to keep these thoughts to yourself as neither of them are true. You evidence a proclivity to lash out at others in this thread when they don't agree with you.

For your information, the FDA-established limit for legitimately advertising a food item is 20ppm. That is based on a total gluten intake of 10mg per day: https://www.glutenfreedietitian.com/how-much-gluten-is-20-parts-per-million/

Here is a visual picture of 10mg of gluten as you might find it in toast crumbs: https://www.glutenfreewatchdog.org/news/what-does-10-mg-of-gluten-look-like/

Does the standard need to be lowered? Perhaps. Apparently, it does not work for the more sensitive subset of the celiac community. But it works for the overwhelming majority. To tighten the standards excessively would likely drive up the costs of already very expensive gluten free foods to an unreasonable level just to accommodate the needs of a relatively small number of people in the celiac/gluten sensitive community and you would likely see the same effect with meds. Is that fair to the celiac community as a whole?

We do understand your frustration but it's important to grasp the big picture.

 

So those of us with severe gluten sensitivity don't get meds. Got it. And yeah, I'm mad--and with good reason. You just handed the rest of us a death sentence.

[knitty kitty]

@LisaGayle,

Are you going to be our allergen- free medication lobbyist?  

I can't take sulfa drugs.  

Maybe you're reacting to the drug itself.

[trents]

6 minutes ago, knitty kitty said:

Maybe you're reacting to the drug itself.

That's what I would look at. I have long suspected that many claims of having a "gluten  reaction" to things labeled "gluten free" are actually reactions to other ingredients and additives or to the main component itself.

Edited February 13, 2023 by trents