Emery Pharma Files an FDA Citizen Petition on Vitamin B6 Toxicity and Urges Warning Label
ALAMEDA, Calif., Sept. 20, 2021 /PRNewswire/ -- September 20, 2021 Emery Pharma filed a Citizen Petition with the FDA requesting the agency to recall all over-the-counter "mega dose" Vitamin B6, due to the risk of severe and potentially irreversible neurotoxicity. Emery Pharma also requests the agency to include a warning on the drug label regarding the danger of neurotoxicity for all Vitamin B6 products sold in the United States.
Vitamin B6 is extensively promoted as a food supplement for health maintenance and wellness. According to the NIH, 28-36% of the US population uses supplements that contain Vitamin B6. During the COVID-19 pandemic, there have been numerous unsubstantiated reports of Vitamin B6 reducing infection severity. When taken in excess, Vitamin B6 can cause symptoms of peripheral neuropathy such as tingling, burning, and numbness of the hands and feet. "Mega doses", ranging from 50-500 mg per day are widely available online, as well as at all major pharmacies and grocery stores as an over-the-counter (OTC) product.
Regulatory agencies of the United Kingdom, European Union, and Australia have established an upper limit of 10 mg, 25 mg, and 50 mg per day, respectively. At Emery Pharma, we believe there is significant evidence to conclude that doses greater than 10 mg daily should not be available over-the-counter, due to the potential for irreversible nerve damage. It is crucial to allow a safety margin between doses that are readily available without a prescription, and doses where neurotoxicity is seen. More importantly, consumer education around the topic is crucial, hence, we request a warning label on all Vitamin B6 products.
Emery Pharma urges the Food and Drug Administration to implement safe guidelines for the use of this widely used and abused vitamin. We request that the commissioner implement the below recommendations:
1) Ask manufacturers of Vitamin B6 or B-Complexes to include labeling regarding the potential toxicity of Vitamin B6. Labeling should include a warning to consumers to discontinue B6 supplementation if they experience signs or symptoms of toxicity.
a. Suggested labeling: "Warning: This medication may be dangerous when used in large amounts or for a long time. Stop taking this medication if you experience tingling, burning, or numbness and see your healthcare practitioner as soon as possible.
2) Reclassify doses greater than 10 mg as "behind the counter", and available by prescription only, under the supervision of a physician with proper blood test monitoring.
"Americans have increased their vitamin and supplement use during the COVID-19 pandemic, bringing the percentage of supplement users to approximately two-thirds of the population. But there is a false belief that vitamins and supplements have been deemed safe by the FDA. Furthermore, many patients don't report supplement usage to their doctors. So it's likely that numerous cases of Vitamin B6 toxicity have gone undetected. When considering the potential for harm, we hope the FDA will take immediate action to implement our recommendation." – Dr. Ron Najafi, CEO, Emery Pharma.
About Emery Pharma:
Emery Pharma is a contract research and development laboratory, specializing in analytical chemistry, microbiology, and cell biology services, utilizing state-of-the-art equipment such as Nuclear Magnetic Resonance Spectroscopy (NMR), LC-MS/MS, HPLC, UPLC, and much more. The facility is located in Alameda, CA, in the San Francisco Bay Area. Emery Pharma's mission is to help "Save Lives and Save the Environment." Emery Pharma is FDA registered and inspected, DEA licensed, and GLP/cGMP compliant. Emery Pharma's previous citizen petition was about NDMA, a known carcinogen and its presence in Ranitidine, sold under many different brands including Zantac, which resulted in the recall of Ranitidine (Zantac) from the US market.
SOURCE Emery Pharma
Share this article