Methylene Blue: An Overview of Wellness Claims and Scientific Context

Methylene blue, a synthetic dye first developed in the 1870s, has historical applications as a textile dye, an antimalarial treatment, and an antidote for cyanide poisoning. Currently, it is approved by the U.S. Food and Drug Administration (FDA) for the treatment of methemoglobinemia, a rare blood disorder. Recently, online promoters have presented it for various wellness purposes.

Promotional Claims

Individuals in wellness and biohacking communities promote methylene blue, citing purported benefits such as improved mitochondrial function. Mitochondria are cellular components responsible for converting nutrients into energy. These claims suggest that enhanced mitochondrial function could lead to outcomes including slowed aging, improved mood, sharper cognition, and alleviation of jetlag.

Scientific Investigation and Findings

Research into methylene blue's effects has included laboratory studies and animal trials. Lorne Hofseth, a researcher at the University of South Carolina College of Pharmacy, notes that these studies indicate methylene blue may facilitate more efficient cellular energy production. This occurs by providing mitochondria with an alternative pathway for electron movement when their typical pathways are compromised or under stress.

Studies conducted in rodents and worms have also suggested that methylene blue can improve brain energy utilization, reduce inflammation, and offer protection against neurological damage.

Regarding human research, preliminary findings from several smaller trials in specific populations have shown potential antidepressant or cognitive benefits from pure methylene blue. However, Hofseth emphasizes that these findings are considered preliminary. He advises against using methylene blue as a supplement, stating that the current risks outweigh the benefits. He also indicates that resources spent on it as a supplement may not yield desired outcomes.

It is noted that promising research is underway in the UK on a modified form of methylene blue for Alzheimer's disease treatment. This modified form differs from the dye currently available for purchase as an over-the-counter supplement.

Nicole Brandt, a professor at the University of Maryland School of Pharmacy, notes the subjective nature of cognitive improvement, attributing daily variations to factors such as sleep and diet.

Potential Risks and Adverse Effects

Both Hofseth and Brandt have identified potential adverse side effects associated with methylene blue. These include:

• Serotonin toxicity: A severe drug reaction that can manifest as elevated blood pressure, diarrhea, seizures, and potentially death. Individuals taking certain antidepressants, such as Zoloft and Lexapro, are particularly susceptible.
• Risk for individuals with G6PD deficiency: Methylene blue may pose dangers for persons with glucose-6-phosphate dehydrogenase deficiency, a genetic disorder affecting red blood cells.
• Visibility: Consumption of methylene blue can result in blue discoloration of teeth, tongue, and urine.

Regulatory Landscape and Product Oversight

Concerns exist regarding the content and quality of over-the-counter methylene blue products. Unlike prescription drugs, dietary supplements in the U.S. do not undergo FDA approval for safety and efficacy prior to market entry. While supplement manufacturers are subject to labeling regulations, inspections, and post-market safety monitoring by the FDA, federal oversight resources are finite. Dr. Joshua Sharfstein, a professor at Johns Hopkins Bloomberg School of Public Health and former principal deputy commissioner at the FDA, advises caution regarding these products due to varying safety standards.

The regulatory classification of methylene blue as a supplement is also unclear. It is listed in an FDA database as a generic drug requiring a prescription. Furthermore, many methylene blue products observed online are not explicitly identified as supplements and are not found in the federal registry of dietary supplement labels, according to Jeff Ventura of the Council for Responsible Nutrition. The FDA did not respond to inquiries regarding the over-the-counter sale of prescription-only methylene blue.

Expert Recommendations

Medical professionals advise individuals considering methylene blue to consult with a clinician beforehand. This consultation can help assess potential risks for adverse side effects. For individuals seeking to address health concerns such as brain fog or fatigue, a primary care provider can offer guidance on appropriate interventions.