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FDA: Risk for biotin interference with lab tests, troponin remains a concern
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The FDA has updated its safety communication to remind the public, health care providers, lab personnel and lab test developers that biotin, or vitamin B7, can significantly interfere with certain diagnostic tests and cause incorrect results that may go undetected. The FDA remains concerned, in particular, with the potential for false results for troponin, which could result in missed diagnoses for MI.
“[T]his interference may cause falsely low results for the presence of troponin, which could lead to missed diagnoses or serious health consequences,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, stated in the safety communication issued on Nov. 5.
The FDA continues to receive adverse event reports indicating biotin interference caused falsely low troponin results, according to the statement.
The FDA first issued a safety communication in 2017 on biotin interference with certain in vitro diagnostic tests and has since issued recommendations to mitigate the potential for interference.
“While there are troponin tests on the market that are not affected by this interference, and several for which manufacturers have already addressed this issue, others remain on the market with the potential for this harmful interference. As part of our commitment to protecting public health and protecting patients, we’re communicating today to be transparent about the affected tests and provide as much detail as possible to the public,” Stenzel stated in the release.
The FDA today released a list of troponin tests in the FDA’s listing database that have not yet mitigated the biotin interference risk, according to the communication.
Biotin is a water-soluble vitamin often found in multivitamins, prenatal vitamins and dietary supplements marketed for hair, skin and nail growth. Many dietary supplements contain up to 650 times more biotin than recommended daily values. Many lab tests use biotin technology as it bonds with specific proteins that can be measured to detect certain health conditions, according to the agency.
The FDA recommends that health care providers discuss with patients any biotin supplements or multivitamin supplements they are taking that may contain biotin and to communicate that information to the lab conducting the testing. - by Scott Buzby
Perspective
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Saleh Aldasouqi, MD, FACE, ECNU
Biotin interference with labs is a recently recognized safety issue in clinical practice, and awareness amongst clinicians is of paramount importance. Because different laboratory facilities (standalone, within clinics or within hospitals) use different lab technologies and assays for different lab tests, awareness among clinicians is of paramount importance. First, every physician needs to communicate with his/her lab to understand if their lab uses tests that may be impacted. Currently, not all tests are impacted by biotin interference. One example is Abbott’s highly sensitive troponin-I assay. In addition to medications, it also is important for clinicians to be aware of all supplements their patients consume.
Physicians should rely on the full patient exam any time they are making a diagnosis, supplemented by appropriate labs or diagnostic procedures or technologies. Any one tool alone shouldn’t be the deciding factor. Rather, the patient’s blood test results, symptoms, exam and other tests such as ECG should all factor into a diagnosis (in the case of suspected diagnosis of MI, for example). When any of these results stand out and don’t seem to match, clinicians should trust their instincts and investigate further.
The FDA has seen an increase in the number of adverse events related to biotin interference. Cardiac patients should stay on top of their health by having an open conversation with their doctor if they are currently taking biotin, be cautious of what supplements they are taking — particularly those labeled for hair, skin and nail benefits, as they may have high levels of biotin and this may not be clear from the name of the supplement — and talk to a health care provider if they suspect that their lab test results may have been impacted by biotin.
In the event of diagnosing MI, and amid the significant associated stress or pain, patients may not consider supplements as something important/relevant to mention. That’s why it’s important for doctors to be aware that biotin interference can occur and specifically ask their patients.
In addition to troponin tests, biotin interference may impact a variety of other laboratory tests, such as tests for thyroid and other endocrine diseases, fertility, various infectious diseases, such as HIV and hepatitis C, various autoimmune diseases, and tumor recurrence. Importantly, Abbott recently conducted a survey that found that 17% of respondents in the U.S. consumed biotin, but only 3% of people taking the supplement were aware of its potential impact on lab tests. In the U.S., the same survey found that 35% of health care providers in the U.S. were somewhat or very familiar. Therefore, not only is it important to educate patients to engage in open dialogue with their doctors about vitamins that are a part of their everyday routine, but to increase awareness among clinicians regarding biotin.
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