Wednesday, November 30, 2016
New Warning about Thyroid Medications
New Warning about Thyroid Medications
New Warning About Thyroid Medications
http://thyroidpharmacist.com/articles/new-warning-about-thyroid-medications
By Dr. Izabella Wentz, Pharm D.
New Warning About Thyroid Medications
Comments
Today is May 18th, 2016, and I wanted to pass on a quick note to you. As you know, I’ve found that 88% of my clients and readers with Hashimoto’s feel best gluten-free, even when they don’t have Celiac disease. Some people have even been able to get into remission by going gluten-free.
We know that in some sensitive individuals (such as those with Celiac disease), even tiny amounts of gluten can produce days and weeks of symptoms.
As of last week, one of my readers has let me know that the Pfizer brand of Cytomel (a T3 containing medication) may have gluten as an ingredient, and she believes this has affected her health, leading to an increase in thyroid antibodies, liver antibodies and symptoms. She has asked me to share this important warning with you.
"I found out yesterday that the Cytomel I have been taking for the past year and a half contains gluten as a filler, when it used to contain corn starch. I spoke with Pfizer and they said it not longer uses corn starch and that there is indeed gluten in the pills. They categorically refused to tell me what they used, but on further research, I believe it is wheat. I have severe gluten sensitivity, and possibly the beginnings of celiac disease, so this is a huge problem. Ive developed high liver enzymes since I started Cytomel, believing it was safe. I also have documented liver damage. This is so alarming to me that Id like Dr. Wentz to help inform others of this terrible danger to those with gluten issues. I am hoping that a compounded T3 and liver support and detox will reverse the issue for me.
I believe the Hashimoto’s community has a right to know that Pfizer changed the filler to a gluten one. It is irresponsible and dangerous."
She also added that despite ongoing numerous interventions that brought her thyroid antibodies from 2700+ to the 400’s, her thyroid antibodies have started to increase after starting the Cytomel.
This is very alarming and disappointing news to me, but also lets me know that we have much more work to do in advocating for our own health.
I spoke with a very nice medical information representative who confirmed that the starch in Cytomel can be corn, potato or wheat derived and that Pfizer is not able to verify the source. I informed her about my experience with Hashimoto’s, my advocacy work, social media and email reach, as well as the high percentage of people with co-occurring Hashimoto’s and Celiac disease.
I made a formal request to make Cytomel gluten-free and after she noted my request, she advised me that receiving additional requests may help the cause. So I’m asking you to help...
If you’re a patient on Cytomel, please take action with me to create change:
- Call Pfizer on their patient line. From the Pfizer website: To report a side effect, adverse reaction, or concern about the quality of a Pfizer product: Call Pfizer at 1-800-438-1985
- Here’s your script:
- “Hello, I am a patient with hypothyroidism who is taking Cytomel, and I’m very grateful for the medication. However, I also have gluten-sensitivity/Celiac disease/Hashimoto’s. The primary reason for hypothyroidism in the United States is Hashimoto’s. 1.2% to 15% of percent of people with Hashimoto’s have Celiac disease, and the risk of Celiac disease increases the longer people have Hashimoto’s. I’d like to request that Cytomel be made gluten free.”
- If you have a personal story of how you felt worse after starting Cytomel, let them know.
- Tips:
- Mindset: Please note, the people on the other end of the phone want to help you, as do their bosses and everyone above them. They just don’t know what you know, so it’s your responsibility to let them know in a kind and respectful, but firm tone.
- Please keep it brief, be respectful, polite and courteous. Medical professionals stop listening when the person on the other side of the phone begins to yell, whine, swear or act rudely.
- Sign my Pfizer, Please Ensure Cytomel is Gluten-Free Petition.
- Having worked in the pharmaceutical industry myself, I am confident that if this message gets to the right person with make-it-happen power, Pfizer will want to make this right for their patients.
- While I love a great conspiracy theory, I don’t think this was an intentional move to harm patients. I can tell you first-hand that every person I’ve met in the pharmaceutical industry cares about people’s health and I don’t think it logically makes sense for a drug company to intentionally cause harm to us.
If you take brand name Cytomel
Alternative gluten-free medications to the Pfizer brand Cytomel include the following generic brands:
- Liothyronine (Mylan)- the manufacturer does not add gluten, starch is corn, rice and/or potato based
- Liothyronine (SigmaPharm)-Per Aurora in the medical information department, this product does not contain gluten, however the mannitol is wheat-derived. The starch is derived from cornstarch. No gluten was detected in the product on testing.
- Liothyronine (Paddock)- (per Cassandra in the medical information department) -all strengths are gluten-free
I also have some good news…
In my 2014 post on gluten in medications (since updated), I wrote about the potential for gluten cross-contamination with Synthroid. I learned about this from a few of my clients with co-occurring Celiac disease, who’d been started on Synthroid and felt worse, or began to have Celiac-related symptoms that resolved after getting off Synthroid. (Synthroid initially didn’t have gluten, but at some point in 2013/2014, reports of potential cross-contamination began to surface, perhaps as things changed within the company).
I verified this cross-contamination issue again with AbbVie (the manufacturer of Synthroid) in late 2015. I was able to express my concern to a representative at AbbVie who assured me that efforts were made to remove gluten from Synthroid.
As per a letter I just received from AbbVie, Synthroid, as of May 2016, is gluten-free. I see this as a victory for thyroid patients and hopefully as a sign that the voice of the thyroid community is heard (and maybe Pfizer will listen too?). **Please note, older batches of Synthroid that are floating around may still contain gluten.
Here are screenshots from my correspondence with AbbVie (address redacted and highlight box mine):
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The most common:
- Synthroid - now gluten-free
- Tirosint- always gluten-free
- Levothyroxine (Mylan)-all strength are certified gluten-free (per Kate in Drug Safety)
- Lannett levothyroxine (Julian)- gluten-free, uses cornstarch
- Levothyroxine (Sandoz)- none of the ingredients are gluten, wheat, rye, or barley derived (per Albert)
To see the other levothyroxine brands/generics and Natural Desiccated products products that are also gluten-free please go to my gluten in medications article.
Natural Desiccated products that are gluten free include:
- WP Thyroid
- Nature-Throid
- Armour
Please note that occasionally the inactive medication ingredients may change, without warning, leading to a gluten-free medication all of a sudden having gluten, or a gluten-containing medication you perhaps wanted to try, being reformulated to become gluten-free.This list is current as of May 2016 and may not be inclusive of every thyroid medication.
I hope that one day there will be a law that ensures all medications containing gluten are labeled and that all pharmaceutical manufacturers will be required to notify pharmacies whenever they change their formulations.
If you felt better gluten-free but then found that you started feeling worse and can’t pinpoint the root cause, check your medications.
Here’s what you can do
The Gluten Free Drugs website (link: http://www.glutenfreedrugs.com/list.htm) is a great place to start, however, as the pharmacist in charge of that website has thousands of drugs to track through calling the pharmaceutical companies, this source may not be updated as quickly.
You can do a search for the medications name, the word package insert and the word PDF on google.
For example “Cytomel AND package insert AND PDF”
The first or second result will usually give you access to the Prescribing Information Package Insert that all medications are required to have. This document will contain a list of ingredients.
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Once you click the link, you will be taken directly to the PDF of the document or a page where you can download the document, like this one. The document you want will be called Physician Prescribing information, Package Insert or something similar.
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Once you open up the document (it will be in PDF form in most cases, or sometimes it may be a web document), you will need to look in the “Description” section of the document, which is usually at the top. You are looking for the words “inactive ingredients”, which in this case are found at the bottom of the section. BINGO, you’ve found the section you’re looking for.
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If you find starch, that’s an indication that the medication may contain gluten. While in some cases, the starch may be potato, tapioca or corn derived, you always want to check! There are other potential words you should look for that may be suspect, besides the obvious wheat, barley, rye, etc. which are rarely listed in medication inserts.
- Starch
- Pregelatinized starch
- Dextrate
- Dextrin
- Dextri-Maltose
- Maltodextrin
- Sodium Starch Glycolate
- Caramel Coloring
More information about ingredients can be found in my Is Your Medication Gluten-Free Article.
Once you see one of these ingredients, you will need to call the manufacturer of each drug, to determine if it is gluten-free. If the manufacturer is listed on your prescription vial, you can do a google search for the name of the manufacturer and the words “customer service”. For example, “Abbvie Customer Service”.
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If the manufacturer of the medication is not listed on your label, your pharmacist can give you the name/phone number of the manufacturer of your medications, and if you’re extra nice, they may offer to do it for you - remember to give them gluten-free cookies as a token of your appreciation ;-) .
I hope this information helps you get your health back.
As I specialize in thyroid medications, I will also keep you posted as soon as I become aware of any potential concerns with thyroid medications. Please be sure to subscribe at www.thyroidpharmacist.com/gift to get updates from me.
Have you found a difference going gluten-free or changing medications? Did you find this post with the screenshots helpful? Please share in the comments below:
Your Thyroid Pharmacist,
Dr. Izabella Wentz, Pharm D.
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