The side effects of biotin may interfere with lab tests intended to diagnose heart attacks, potentially resulting in misdiagnoses and potentially serious health consequences, according to a warning issued by federal regulators.
Many laboratories do not appear to be taking steps to avoid serious harm to patient, according to a safety communication issued by the FDA on Tuesday, which indicates that biotin supplements may seriously interfere with lab test results, potentially leading to patient deaths.
Biotin, also known as vitamin B7, is a water soluble vitamin commonly used in multivitamins and dietary supplements sold promoting benefits for the nails, hair, and skin. However, many labs also use biotin technology to conduct certain tests, which is why it can interfere with test results.
Biotin bonds with specific proteins, helping to detect certain health conditions. It is commonly used to test for biomarkers for cardiac health and used in hormone tests. However, the FDA issued a biotin warning in November 2017, indicating that patients who take biotin and have lab tests conducted can receive false positive or false negative results. In some cases, those results can be deadly.
For example, biotin can interfere with lab tests detecting troponin levels. Troponin is a biomarker used to diagnose increased risk of heart attack. However, when biotin affects the test it can lead to a misdiagnosis. In one case, a patient was misdiagnosed because of a skewed lab test and died as a result of complications linked to heart problems.
The new warning indicates some labs have heeded the FDA warning and begun implementing procedures to mitigate the interference of biotin on lab tests. However, too many have failed to address the problem, according to the agency.
As a result, the FDA has launched a biotin interference webpage to provide information to labs and notify the public of the serious risk.
The levels of biotin in vitamins and supplements can vary widely. Some products may contain up to 650 times the recommended daily intake of 0.03 mg. The daily recommended intake typically does not cause interference in lab tests. However, amounts above that can interfere with lab results.
Many doctors also often recommend up to 300 mg per day for certain medical conditions, such as multiple sclerosis. Those doses will interfere with lab tests.
Often, skewed test results caused by increased biotin levels go undetected by the lab and healthcare provider, the FDA warns.
The agency’s warning emphasized the importance of patients, doctors, and labs working together to prevent misdiagnosis from heightened levels of biotin from interfering with lab results.
The FDA recommends patients talk to their doctor if they are currently taking biotin and need lab tests conducted. Patients should be aware biotin is included in multivitamins, prenatal vitamins, and supplements sold for hair, nails, and skin. The amount of biotin in vitamins and supplements can vary significantly.
Lab personnel should focus on communicating the risk biotin has on lab tests to both patients and doctors before and after suspected biotin interference. When collecting samples in the lab, personnel should ask patients if they are taking biotin or biotin containing supplements and if they are taking the recommended daily level or higher.
The FDA is requesting that anyone who has experienced side effects as a result of this issue contact the FDA’s MedWatch Adverse Event Reporting program