High biotin doses may interfere with some SERUM blood tests, e.g. thyroid, anaemia. Those on Ibrutinib please note!

[AussieNeil]

Those taking biotin PLEASE take note! Biotin (vitamin B7) is a common component of immunoassays (a technique for measuring blood serum levels) and a small study has shown an alarming impact on the accuracy of some commonly performed blood tests. Biotin supplements are commonly taken to reduce nail splitting for those on Ibrutinib therapy and it is regularly taken for other reasons.

The current best recommended practice is to cease taking biotin at least 72 hours prior to a scheduled blood test and allowing a week to be absolutely certain. Don't forget other possible sources of biotin, including B-complex vitamins, Coenzyme R, Dietary supplements for hair, skin, or nail growth, Multivitamins, Prenatal vitamins,

Vitamin B7 supplements, Vitamin H.

Biotin use can also interfere with testing to see if you have had a heart attack, so please mention you are taking high dose biotin if you have this test: healthunlocked.com/cllsuppo...

From MedPageToday: medpagetoday.com/Endocrinol...

Biotin supplements taken at common over-the-counter doses can can interfere with the results of certain hormone assays, giving falsely high or low results that could lead to a misdiagnosis, researchers reported.

In six healthy adults taking 10 mg/day of biotin for 1 week, biotin-associated interference was found in nine of 23 biotinylated assays (39%), compared with zero of 14 non-biotinylated assays (P=0.007 for comparison), according to Danni Li, PhD, of the University of Minnesota in Minneapolis, and colleagues.

:

The blood samples were sent to four different clinical laboratories using different diagnostic systems. Assays were performed to assess levels of nine hormones: thyroid-stimulating hormone, total thyroxine, total triiodothyronine, free thyroxine, free triiodothyronine, parathyroid hormone, prolactin, N-terminal pro-brain natriuretic peptide, and 25-hydroxyvitamin D. Assays were also performed for two non-hormones: prostate-specific antigen and ferritin. (My emphasis)

In this small study, a 37% reduction from baseline was noted in thyroid-stimulating hormone levels with one test method and a whopping 94% reduction from baseline with another.

The results from a further test raised concerns with the possible failure to identify congestive heart failure.

The researchers suggested that "It may be advisable for patients to stop taking biotin, preferably for a week as studied herein, before undergoing laboratory testing. Alternatively, in the presence of biotin ingestion, non-biotinylated assays would be preferred."

Note that "the minimal dose and duration required to alter test results remains undetermined."

Update June 2018

FDA Warns that Biotin May Affect Some Lab Test Results

The FDA urges the general public to that know that biotin is found in many over-the-counter supplements in levels that may interfere with laboratory tests. Examples include:

B-complex vitamins

Coenzyme R

Dietary supplements for hair, skin, or nail growth

Multivitamins

Prenatal vitamins

Vitamin B7 supplements

Vitamin H

Patients should tell their healthcare practitioners if they are taking or plan to take biotin or a supplement containing biotin, and consider the possibility that biotin was the cause of test results that don't seem to make sense. Healthcare practitioners may advise their patients to discontinue taking biotin supplements a few days before having lab tests done.

labtestsonline.org/news/fda...

Further discussion: healthunlocked.com/cllsuppo...

JustLabScientist explained what blood tests are affected in a July 2019 reply thus:

"Biotin interferes with some very important blood tests because biotin and streotavidin, which binds to biotin, are used in the detection scheme for many things—such as hormones, tumor markers, vitamin assays, infectious disease tests (like hepatitis, HIV, etc), iron/iron binding, ferritin, cardiac tests, many antibody tests, and others.

Tests that are not affected are basic things like blood cell counts (CBC), glucose, cholesterol, creatinine, enzymes, electrolytes. However, sometimes doctors add tests to orders and the sample already in the lab gets used for that additional testing. So, it’s best just to stop for a week before regardless of what test is ordered.

Supplementing biotin prior to having blood drawn can cause the results to be erroneously high or low, depending upon the specific design of the test. Different lab test manufacturers design differently. Since you don’t know exactly which test is used, it’s best to be off biotin supplements for a week prior to blood collection.

I hope this helps. If you have a question about a specific type of test, I’d be happy to try to answer it for you."

Neil

[AmericanRonin]

For the past 15 months, I have been taking 10,000mcg of Biotin each day. It seemingly helped restore my fingernails to their original strong selves.

I previously posted about it here:

healthunlocked.com/cllsuppo...

If the only harm is false blood results, perhaps I will continue to take it...and then, as your post suggests, stop taking it for a week prior to a blood test (which I have reduced the frequency of to once every 3 months).

[AussieNeil Partner Administrator in reply to AmericanRonin]

I note that you are taking the same dose as those in the study. 10 millgrams per day (mg/day) is 10,000 micrograms per day (mcg/day), so yes you would be wise to stop taking it for at least a week before blood tests where the accuracy could be adversely affected. Note that the study looked at blood tests which used biotin compound to measure blood serum levels, not blood cell counts. So red blood cell, platelet and the various white blood cell counts (including lymphocytes and neutrophils) would not be impacted.

Anyone suffering from splitting fingernails has my sympathy. Importantly, I don't see that this concern about biotin affecting blood serum test results as a reason for stopping taking biotin - other than temporarily so that serum blood tests are more accurate. It is very important to understand that taking biotin doesn't change the actual serum levels in our bodies, it just interferes with the testing method, so the test may return an incorrect result.

Neil

[AmericanRonin in reply to AussieNeil]

Thanks, Neil, Biotin "seems" like a good product for me, so I will continue taking it. Though I just read a prior post today saying that Vitamin E is a no-no with Ibrutinib, so I may stop taking that. (It's always something....)

[maggiesgrandmom in reply to AmericanRonin]

Yikes! American Ronin, I remember suggesting you take the Biotin. I am still taking the 5,000mg daily even though I have been off the Ibrutinib for 10 months. I am enjoying my nails now. AussieNeil thank you for this. I will stop it for a while before my next blood test as I have hemochromatosis and need to test my ferritin all the time. It has been fine lately. I wonder if the biotin is affecting it.

[AmericanRonin in reply to maggiesgrandmom]

Under what circumstances did you stop taking Ibrutinib?

[maggiesgrandmom in reply to AmericanRonin]

After 22 months I got too many cardiac symptoms, tachycardia, hypertension, atrial fib possibly, could not remember what I was saying or complete a sentence. So I went off. I was so scared that I was getting worse but it turned out to be withdraw symptoms. Blood levels are still ok now after ten months! Just have very bad hypogammaglobulinemia. Have had some infection problems. Took IVIG after pneumonia but it caused my liver enzymes and ferritin to go way up. So they are back to normal now and worried about trying the IVIG again. Holding off for now.

Hope you are safe over there. Are you still in Korea? North or South?

[AmericanRonin in reply to maggiesgrandmom]

Good luck with everything. I am in Beijing now and either South Korea or Tokyo-bound in a few days. KJU (Kim Jong Un) keeps my mind off CLL!

[maggiesgrandmom in reply to AmericanRonin]

Oh my gosh, you are so brave! God bless you.

[AmericanRonin in reply to maggiesgrandmom]

Everyone in this CLL group is brave for dealing with what they have to deal with every day.

[Justasheet1]

Neil,

As someone taking thyroid medication, I certainly will take notice.

Thanks,

Jeff

[cllady01 Former Volunteer]

Neil, a good find ! Thank you!

All who have thyroid issues and/or anemia need to be alerted.

I know the problem has been stated it interferes with ferritin reading, but the anemia issue is not one easily sorted as to cause according to what I have been able to discern from searching blood-related articles.

[mia7170 in reply to cllady01]

I recently had blood work. My iron level and iron saturation is very high. My UIBC is too low. My thyroid antibodies were also high. I am waiting to see the specialists but I am wondering if my results are incorrect due to my intake of biotin. Any thoughts? Anyone?

[AussieNeil Partner Administrator in reply to mia7170]

Quite likely for your thyroid tests, but you'll need to check with your pathology lab:

Stay off biotin for a week before repeating your blood tests and be aware that it may be present in a range of supplements: labtestsonline.org/news/fda...

[sandybeaches]

can these tests be done any other way, or the results adjusted by the lab if it is noted of the dosage of biotin that is taken?

Sandy Beaches

[AussieNeil Partner Administrator in reply to sandybeaches]

As I noted 'In this small study, a 37% reduction from baseline was noted in thyroid-stimulating hormone levels with one test method and a whopping 94% reduction from baseline with another.', so indeed there are alternative methods for at least this test and I expect others.

Neil

[shazie]

Thanks Neil. I was wondering why my TSH level has been off. I have to discuss this with my physician tomorrow. I am wondering if this affects ferritin level too?

Great post. Again I really appreciate it.

[AussieNeil Partner Administrator in reply to shazie]

The Medpage article specifically mentions ferritin as one of the tests assessed for potential impact, but doesn't state what effect was found (hence my mention of anaemia in the post title). Unfortunately the link to the source doesn't work (probably because it is paywalled) and the abstract doesn't provide specific information on ferritin testing: jamanetwork.com/journals/ja...

Perhaps your doctor has a JAMA subscription and can check out the source and you can let us know?

Neil

[BeckyLUSA]

Dumb Question. The original article stated "10,000 mg", while someone else mentioned "mcg". Are these the same?

[AussieNeil Partner Administrator in reply to BeckyLUSA]

Correction, the original article stated 10mg. 10,000mg is a gram - that's a huge amount of biotin, considering the dietary recommendation is 30 μg/day!

mg is the abbreviation for milligram and mcg that for microgram (correctly µg but many fonts don't include the micro (µ) symbol, hence mcg). There are 1,000 µg/mcg in one mg.

Neil

[AussieNeil Partner Administrator]

From this later post on what to do to ensure your blood tests are accurate if you are taking high doses of biotin:

In general, patients taking over-the-counter biotin should be advised to withhold the supplement for at least 48 hours preceding their blood tests if clinically possible.

More details:

healthunlocked.com/cllsuppo...

[JustLabScientist]

I think that the beginning post for this had the units incorrect. It probably should've been 10,000 mcg/day (10 mg/day). Even 10 mg is a fairly high dose, but probably not uncommon.

Also, remember, that not all tests are affected (not even all of the tests being discussed). So, your past results may really be OK. There are a lot of considerations. For one, the half-life of biotin is only 2 hours. The level in your blood varies greatly during the day because of this. It should take about 5 half-lives to clear. But, this is based upon a single dose, and clearance takes longer if you are continuously taking biotin. So, some labs recommend no supplementation for 72 hours, just to be on the safe side.

Even more important is to know what testing system and assay is being used for your testing. The only tests that are affected are those that utilize biotin-streptavidin complexing. The lab doing your testing may not be using any of these systems. So, you may not need to stop supplementation depending upon the specific manufacturer and assay used at the laboratory performing your testing.

Be informed! More than just thyroid and anemia assays can be affected on a system that utilizes biotion-streptavidin. The types of tests are called immunoassays because they use antibodies to detect whatever is being measured. Many things are measured using immunoassays--infectious disease tests, drug tests, hormones, tumor markers, cardiac markers, anemia assays (such as ferritin, folate, B12), and many others. But, there are many lab tests that are not immunoassays, and these won't be affected. You don't need to worry about blood counts, clotting tests, general chemistry tests (like glucose, creatinine, most lipids, enzymes, electrolytes, blood gases, urinalysis), and others. So, be alert and get informed prior to getting testing done.

You don't need to get your testing collected at your doctor's office. You can get a written order and take it to another lab for blood collection. Choose wisely--a lab that uses tests that do not exhibit biotin interference and one that your insurance accepts. But, if you just can't do that or don't want to, then don't use the biotin for at least 72 hours prior to blood collection. That's the safest and easiest way.

All that being said, ALWAYS make sure to inform every healthcare provider that you are taking biotin. You may have emergent need for blood testing, in which case you may have levels of biotin in your system that could interfere. Health care providers often don't know about this issue or what systems and assays that their lab utilizes. So, you need to make sure that they know and verify interferences prior to treating you--any lab should be able to look up a specific assay in a moment to find out if their assay uses biotin-streptavidin, as it's in the package insert. And, labs that utilize these should have cautionary comments on the test reports (although, often health care providers don't read these--sad, but true). We need to manage our own care.

[AussieNeil Partner Administrator in reply to JustLabScientist]

Thank you for your informative expansion. With regard to the Biotin ( vitamin B7) dose, the Jama reference in the Medpage Today article didn't specifically reference the research paper, which I've referenced here:

jamanetwork.com/journals/ja...

I note that Medpage Today did correctly quote the dose stated in research paper, namely 10mg/day (10 milligrams per day), whereas B7 doses in B vitamin supplements are typically a thousand times smaller (micrograms - mcg or µg).

Irrespective of the accuracy of the dose used, as you highlight, if those taking Biotin can't determine if their pathology lab's testing will be affected, they should stop taking Biotin for a minimum of 72 hrs/3 days before a scheduled blood test if possible.

Neil

[AussieNeil Partner Administrator]

I happened to notice that on my trial screening blood tests, that the Beta 2 Microglobulin (B2M) test results can be influenced by taking biotin. Given B2M is a prognostic test for CLL survival time, ensure that you improve the accuracy of B2M testing by staying off biotin/vitamin B7 for at least 3 days before your B2M blood test.

Neil

[AussieNeil Partner Administrator]

UPDATE: The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication

Date Issued: November 5, 2019

The U.S. Food and Drug Administration (FDA) is updating our 2017 safety communication to remind the public, health care providers, lab personnel, and lab test developers that biotin, often found in dietary supplements, can significantly interfere with certain lab tests and cause incorrect results that may go undetected. The FDA wants to make the public and health care providers aware about biotin interference with lab tests so that patients, physicians, and laboratories can work together to help prevent adverse events.

fda.gov/medical-devices/saf...

[Jemorgen]

Hi Neil - this came up on a thread the other day. I see it was updated July 2019. Do you know if there’s any further update? I was trying to add the link to my original post (about my update being on ibrutinib for 5 months) but don’t seem to be able to do so on the mobile app.

Thanks

Heather 🇨🇦

[AussieNeil Partner Administrator in reply to Jemorgen]

Hi Heather,

The FDA do update their postings, and there is no update to their warning (as I would expect). I've updated your reply here to reference this post:

healthunlocked.com/cllsuppo... as I assume you wanted.

Per this post and PaulaS 's reply to you, you only need to stop taking biotin a minimum of 72 hours before having any blood test sensitive to high biotin blood serum levels.

Neil

[Jemorgen in reply to AussieNeil]

Thanks Neil!