From FDA--Biotin May Interfere With Lab Results

NickNack · ‎03-10-2010

I thought this notice from the FDA was interesting. I used to take Biotin for my nails. It didn't seem to help, so I quit. I told a friend about this notice, and she said that one of her lab results was really strange. She's going to stop taking Biotin and have them retest it.

_____________________

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

A MedWatch Safety Alert was just added to the FDA Medical Device Safety webpage.

TOPIC: Biotin May Interfere with Lab Tests - Safety Communication: Update

AUDIENCE: Consumer, Patient, Health Professional

BACKGROUND: Many dietary supplements promoted for hair, skin, and nail benefits contain biotin levels up to 650 times the recommended daily intake of biotin. Physicians may also recommend high levels of biotin for patients with certain conditions such as multiple sclerosis. Biotin levels higher than the recommended daily allowance may cause interference with lab tests.

ISSUE: The FDA updated the 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. Incorrect test results may lead to inappropriate patient management or misdiagnosis. For example, a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks, may lead to a missed diagnosis and potentially serious clinical implications.

RECOMMENDATION: Please click on the "Read Safety Communication" button below to read specific recommendations for consumers, health care providers, lab personnel, and lab test manufacturers and developers.

Health care providers, consumers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

Read Safety Communication

The Bluebird Carries The Sky On His Back"
-Henry David Thoreau

Bridgegal · ‎03-09-2010

That is one reason I don't take any supplements. They aren't tested and regulated and you never know how they might interact negatively with any prescription drugs that we take or apparently test results.

santorini · ‎03-09-2010

I take it regularly and don't plan to stop. If I ever plan to have tests done, I will skip it for a few days before the test.

Shelbelle · ‎03-09-2010

@santorini wrote:
I take it regularly and don't plan to stop. If I ever plan to have tests done, I will skip it for a few days before the test.

This is old news, been posted here several times. I take a large dose it daily, and yes, if my blood is to be drawn, will stop it a few days ahead. Most Biotin is eliminated in your urine anyway.

SilleeMee · ‎05-22-2016

@Bridgegal wrote:
That is one reason I don't take any supplements. They aren't tested and regulated and you never know how they might interact negatively with any prescription drugs that we take or apparently test results.

That is incorrect. The FDA does regulate supplements.

https://www.fda.gov/food/dietary-supplements

tsavorite · ‎03-09-2010

@Shelbelle wrote:
@santorini wrote:
I take it regularly and don't plan to stop. If I ever plan to have tests done, I will skip it for a few days before the test.
This is old news, been posted here several times. I take a large does it daily, and yes, if my blood is to be drawn, will stop it a few days ahead. Most Biotin is eliminated in your urine anyway.

That's what I thought....I know from personal experience that biotin makes me have to go wee almost constantly if I try to take it! Gave up on it....told my H about this and he tried taking it for a few days....came home from work and told me it was making him go pee all day long LOL! Tossed it!!

sann · ‎05-30-2012

Poo

@Bridgegal wrote:
That is one reason I don't take any supplements. They aren't tested and regulated and you never know how they might interact negatively with any prescription drugs that we take or apparently test results.

Very true. They are not regulated. Natural does not always mean safe.

noodleann · ‎06-10-2015

@NickNack wrote:
I thought this notice from the FDA was interesting. I used to take Biotin for my nails. It didn't seem to help, so I quit. I told a friend about this notice, and she said that one of her lab results was really strange. She's going to stop taking Biotin and have them retest it.
_____________________
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
A MedWatch Safety Alert was just added to the FDA Medical Device Safety webpage.

TOPIC: Biotin May Interfere with Lab Tests - Safety Communication: Update

AUDIENCE: Consumer, Patient, Health Professional

BACKGROUND: Many dietary supplements promoted for hair, skin, and nail benefits contain biotin levels up to 650 times the recommended daily intake of biotin. Physicians may also recommend high levels of biotin for patients with certain conditions such as multiple sclerosis. Biotin levels higher than the recommended daily allowance may cause interference with lab tests.

ISSUE: The FDA updated the 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. Incorrect test results may lead to inappropriate patient management or misdiagnosis. For example, a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks, may lead to a missed diagnosis and potentially serious clinical implications.

RECOMMENDATION: Please click on the "Read Safety Communication" button below to read specific recommendations for consumers, health care providers, lab personnel, and lab test manufacturers and developers.

Health care providers, consumers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

Read Safety Communication

Thanks for posting this, @NickNack . I got the message from the FDA and hoped someone would post about it, since it's an updated warning that anyone taking biotin should know about.

Specifically, " . . . the FDA is particularly concerned about biotin interference causing a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks, which may lead to a missed diagnosis and potentially serious clinical implications. The FDA continues to receive adverse events reports indicating biotin interference caused falsely low troponin results."

There's no way for most people to know when they're going to have a heart attack so they can't discontine the supplement in anticipation of the event. That suggests that it's especially important to make sure your medical records reflect your use of biotin as a supplement.

The FDA further states that "Since the FDA's safety communication on this topic in 2017, some lab test developers have been successful at mitigating the biotin interference of their assays, but others have not yet addressed it. The FDA remains concerned about troponin laboratory tests that have not addressed the risk of biotin interference. The FDA has posted a webpage onBiotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference to notify the public about troponin assays where the risk of biotin interference has not yet been addressed."

Last, "Consider that the daily recommended allowance for biotin is 0.03 mg and that amount does not typically cause interference in lab tests." That amount is what's usually listed as "30 mcg" on supplement labels.

All this info I've posted can be found in the "Safety Communication," the last link in NickNack's post. Thanks again for posting about it, @NickNack.

ann1989 · ‎02-24-2019

I do take Andrew Lessman's supplements and he has biotin in many products. My hair grew extremely fast once I started taking it and is now longer than it's been in years. I take his Healthy Hair, Skin and Nails supplement. My nails though still break like they did before but I have been remiss in taking care of them by filing them during their growth. I think if I was better at that, they would be less likely to chip and break.

He also has biotin in his Essential 1 multi vitamin which I take everyday. He also has it in a supplement called Vitamin C 500 plus B Complex that I was taking everyday.

I have had lab tests but they required fasting. Biotin is water soluble and leaves the body when you urinate. My lab tests have not been affected.

Sooner · ‎03-10-2010

@Shelbelle wrote:
@santorini wrote:
I take it regularly and don't plan to stop. If I ever plan to have tests done, I will skip it for a few days before the test.
This is old news, been posted here several times. I take a large does it daily, and yes, if my blood is to be drawn, will stop it a few days ahead. Most Biotin is eliminated in your urine anyway.

It's new news to me!