Sept. 20, 2021 -- Vitamin B6, wide promoted and taken arsenic a supplement, should transportation a informing statement astir imaginable nervus problems, according to the CEO of a ample declaration probe laboratory successful Northern California.
And doses supra 10 milligrams should beryllium switched from over-the-counter to medicine status, says Ron Najafi, PhD, CEO of Emery Pharma, who filed a citizen's petition with the FDA connected Friday. He wants the bureau to modulate and revise manufacture guidance connected precocious doses of over-the-counter vitamin B6, owed to risks of terrible toxic vulnerability that causes numbness and tingling of the hands and feet.
"What's the constituent of taking 100 milligrams oregon 50 milligrams?" Najafi says, pointing to a recommended regular magnitude that is 2 milligrams oregon less. Yet, helium says, mega doses of 50 mg to 500 mg are wide disposable implicit the counter.
He suggests a informing statement that says: "This medicine whitethorn beryllium unsafe erstwhile utilized successful ample magnitude oregon for a agelong time. Stop taking this medicine if you acquisition tingling, burning, oregon numbness, and spot your wellness attraction practitioner arsenic soon arsenic possible."
"This is simply a vitamin that astir 30% of the colonisation is taking," says Ana Najafi, PharmD, a co-author of the petition who’s connected the unit astatine Emery Pharma. Supplement makers beforehand B6 for bosom health, a healthy immune system, and a steadfast nervous system.
Ron Najafi points to proposal from the National Health Service successful the United Kingdom that advises radical not to instrumentality much than 10 mg of B6 daily.
Industry groups pushed backmost connected Najafi’s petition, saying it is not necessary.
More connected Vitamin B6 and How Much Is Enough
Vitamin B6, a water-soluble vitamin, is besides recovered successful foods similar poultry, fish, potatoes, bananas, and fortified cereals. It helps with mean brain improvement and keeps the tense strategy and immune system healthy.
Adults request 1.2 to 2.0 milligrams a day, depending connected property and gender; the highest magnitude is recommended for large oregon breastfeeding women. Two cups of chickpeas person 2.2 mg; a 3-ounce chickenhearted bosom has 0.5 mg.
Deficiency of vitamin B6 is much apt successful radical with kidney oregon autoimmune disease, successful radical who person occupation absorbing nutrients from foods, oregon successful those who person alcohol dependence.
Case Histories
In the petition, Najafi lists the lawsuit past of a 63-year-old antheral who began taking 100 mg of vitamin B6 regular successful July 2020. By May 2021, helium had vigor sensitivity, tingling successful the hands and feet, and numbness successful his hands. He besides reported utmost thirst, facial flushing, and predominant urination.
Doctors did aggregate tests, including checking for specified conditions arsenic type 2 diabetes and multiple sclerosis, and recovered each tests mean but the vitamin B6 level, which was 5 times the median mean range.
Even aft stopping the supplement, symptoms continued for a month, past subsided but didn't vanish adjacent by the extremity of September.
Another lawsuit history, reported successful 2020 successful the French aesculapian journalLa Revue de Medecine Interne, described a 92-year-old pistillate who had utilized precocious levels of vitamin B6 supplements and had occupation walking owed to nervus issues. Doctors said her usage of excessively overmuch vitamin B6 was the cause, uncovering humor levels astir 6 times normal.
The researchers warn: "Vitamin B6 is contained successful a fig of over-the-counter drugs and vitamin supplements. It whitethorn origin terrible neurological occupation successful lawsuit of overdosage."
What Other Research Shows
In its reappraisal of the evidence, Mayo Clinic says B6, erstwhile promoted to forestall bosom and humor vas disease, doesn't look to trim those risks. It could assistance dainty morning sickness during pregnancy, a familial benignant of anemia, and possibly premenstrual syndrome (PMS).
Most of the grounds astir toxicity, Najafi says, is from lawsuit reports. In a 2017 study successful a toxicology journal, researchers said much than 50 cases of a sensory nervus symptom owed to vitamin B6 supplements were reported from 2014 to 2017.
The lowest dose reported to origin adverse effects is 50 mg, Najafi says successful his petition, citing a 1987 survey that helium acknowledges has issues with methodology.
Industry Responses
There is nary request for a informing statement connected Vitamin B6, accidental spokespeople from 2 manufacture groups that issued statements successful effect to the petition.
"Vitamin B6 plays a relation successful galore functions successful the assemblage and tin beryllium safely consumed from foods and dietary supplements," says Andrea Wong, PhD, a elder vice president astatine the Council for Responsible Nutrition. "The tolerable precocious intake level for vitamin B6 is 100 mg successful adults, based connected the hazard of sensory neuropathy; however, probe indicates that sensory neuropathy usually develops astatine acold higher doses. We promote individuals to speech to their wellness attraction supplier astir what levels of vitamin B6 are due to enactment their health."
In different statement, Jay Sirois, PhD, of the Consumer Healthcare Products Association, besides cites the bounds of 100 mg, acceptable by the Food and Nutrition Board of the National Academies of Sciences, Engineering, and Medicine, and that broadside effects linked with B6 are ''likely the effect of taking highly precocious doses for extended periods of time.
Expert Perspective
"We've known for a agelong clip that vitamin B6 excess tin pb to numbness and tingling, but this is predominantly with supplements," says Connie Diekman, a registered dietitian and a nutrient and nutrition advisor successful St. Louis who is besides a erstwhile president of the Academy of Nutrition and Dietetics. "You can't devour capable foods with B6 to get to a toxic level."
But with supplements, she says, ''if the depletion to excess occurs implicit time, it tin spell to that neuropathy."
"When you look astatine what they are saying [in the petition], I deliberation it is precise due to inquire that [federal officials] reappraisal the existent assemblage of grounds and dosage arsenic it relates to toxicity."
But close now, "I'm not definite the assemblage of grounds supports the request for a informing statement yet."
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