Is low-dose vitamin B6 linked to the development of peripheral neuropathy?

Vitamin B6—also known as pyridoxine, pyridoxamine, pyridoxal and their phosphate derivatives—may cause peripheral neuropathy when taken in high amounts (≥ 250 mg/day). Recent evidence suggests that peripheral neuropathy may also be associated with lower doses that are within the dosing range recommended for vitamin B6-containing health products currently marketed in Canada. To examine this issue, a Health Canada safety review assessed the risk of potential peripheral neuropathy with the use of vitamin B6-containing natural health products (NHPs) and prescription drugs. Health Canada assessed 17 (generally inconclusive) case reports of peripheral neuropathy in patients taking either vitamin B6-containing NHPs (14 cases) or vitamin B6-containing prescription drugs (3 cases). As well, Health Canada reviewed nine published articles that supported a possible link between the use of vitamin B6-containing health products at daily doses as low as 10 mg of vitamin B6 and the risk of peripheral neuropathy. No well characterized risk factors for developing peripheral neuropathy while using vitamin B6-containing health products were found.The review did not include vitamin B6-supplemented foods, including caffeinated energy drinks. These products may contain amounts of added vitamin B6 similar to that found in NHPs, but will be reviewed by Health Canada separately. The safety review also did not include whole foods or fortified foods (e.g., breakfast cereals) containing vitamin B6, as no safety concerns have been identified with these products. Foreign regulatory agencies and international pharmacovigilance groups have identified cases of neuropathy with the use of vitamin B6-containing health products. Based on their findings, one foreign agency (Australia) has implemented label updates for vitamin B6-containing health products to include the risk of peripheral neuropathy when the daily dose is > 10 mg of vitamin B6. Another agency (European Commission) has made a recommendation to lower the tolerable upper intake level of vitamin B6 to 12 mg/day for foods. More than 4,000 vitamin B6-containing NHPs have been authorized by Health Canada under the NHP Regulations with recommended daily doses of 10 mg vitamin B6 or higher. These products are typically used to help in energy metabolism and tissue formation, form red blood cells, prevent vitamin B6 deficiency, and maintain/support the body's ability to metabolize (process) nutrients.Prescription drugs containing vitamin B6 are authorized for sale in Canada for the treatment of nausea and vomiting in pregnancy (pyridoxine/doxylamine [Diclectin, generics]), or for use as a pregnancy multivitamin (Pregvit, Pregvit Folic 4 or 5, generics). Approximately 230,000 new prescriptions for vitamin B6-containing drugs are filled in Canada annually.Health Canada safety review conclusionsA possible link exists between vitamin B6-containing NHPs and the risk of peripheral neuropathy, when the daily dose of vitamin B6 (pyridoxine) is ≥ 10 mg.Health Canada will update the monograph for vitamin B6-containing NHPs to include the risk of peripheral neuropathy. License holders are expected to update the risk information on product labels for all licensed vitamin B6-containing NHPs with a daily dose of 10 mg vitamin B6 or higher to:include information about the warning signs and symptoms of peripheral neuropathy, including sensory nerve problems (numbness, tingling and pain in the extremities), and advise consumers to stop using these NHPs and consult a healthcare professional if symptoms occur. Health Canada’s review did not find sufficient evidence to establish a link between vitamin B6-containing prescription drugs and the risk of peripheral neuropathy despite these products containing similar amounts of vitamin B6 to what is found in NHPs. No update to product safety information for vitamin B6-containing prescription drugs is recommended. Health Canada plans to inform healthcare professionals and consumers about these updates for vitamin B6 (pyridoxine) through a Health Product InfoWatch communication and a social media campaign.Reference:Health Canada. Summary Safety Review - Vitamin B6 health products - assessing the potential risk of peripheral neuropathy. March 18, 2026. (accessed March 19, 2026).

Is low-dose vitamin B6 linked to the development of peripheral neuropathy?

Register for free access or login.

Related Topics