Product
Vitamin B6-containing heath products (natural health products [NHPs] and prescription drugs), with a daily dose of 10 mg vitamin B6 or higher
Potential Safety Issue
Peripheral neuropathy (damage to or disease affecting peripheral nerves)
Key Messages
- Health Canada’s review found a possible link between vitamin B6-containing NHPs and the risk of peripheral neuropathy, when taken at daily doses of 10 mg vitamin B6 or higher.
- 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.
- Health Canada will update the monograph for vitamin B6-containing NHPs to include the risk of peripheral neuropathy. Health Canada expects license holders 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 these symptoms occur.
- Health Canada does not recommend an update to the product safety information in the Canadian product monograph (CPM) for vitamin B6-containing prescription drugs at this time, as standardized prescription practices and monitoring of pregnant patients by healthcare professionals are already in place.
- Health Canada will also inform healthcare professionals and consumers about these updates through a Health Product InfoWatch communication and a social media campaign.
Overview
Vitamin B6, also known as pyridoxine, pyridoxamine, pyridoxal and their phosphate derivatives (chemical compounds derived from phosphoric acid), is naturally found in many foods, added to others (supplemented foods and fortified foods), and available as a health product (NHPs and prescription drugs).
When consumed in high amounts (250 mg vitamin B6/day and above), vitamin B6-containing health products may cause peripheral neuropathy. In recent years, however, evidence has suggested that peripheral neuropathy may also be associated with lower doses, which are within the dose range of vitamin B6-containing health products (NHPs and prescription drugs) currently marketed in Canada.
In 2024, Health Canada reviewed this potential risk with the use of vitamin B6-containing NHPs. This safety review was triggered by a scientific study reporting international cases of peripheral neuropathy associated with the use of vitamin B6 health products for daily doses under 100 mg, and after reviewing assessments completed by foreign regulatory agencies (Australia’s Therapeutic Goods Administration [TGA], Netherlands Pharmacovigilance Centre Lareb and the European Food Safety Authority [EFSA]).
In 2025, Health Canada also reviewed the potential risk of peripheral neuropathy with the use of vitamin B6-containing prescription drugs to determine if additional risk mitigation measures were needed for these types of products.
Supplemented foods, including caffeinated energy drinks, were not included as part of these reviews and the use of vitamin B6 in these foods is reviewed separately. However, consumers should note that these products may also contain higher amounts of added vitamin B6, similar to NHPs.
Vitamin B6 that is naturally found in whole foods, and vitamin B6 in fortified foods such as breakfast cereals, have not been identified as a safety concern and were not included as part of these reviews.
Use in Canada
- Vitamin B6 is authorized in Canada for use in NHPs, typically 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. Over 4,000 vitamin B6-containing NHPs have been authorized by Health Canada under the Natural Health Products Regulations with recommended daily doses of 10 mg vitamin B6 or higher.
- Prescription drugs that contain vitamin B6 are authorized for sale in Canada for the treatment of nausea and vomiting in pregnancy under the brand name Diclectin (pyridoxine/doxylamine), or for use as a pregnancy multivitamin under the brand names Pregvit and Pregvit Folic 5. Generic versions are also available. Every year, approximately 230,000 new prescriptions for vitamin B6-containing drugs are filled in Canada.
- Vitamin B6-containing health products have been marketed in Canada for over 20 years.
Safety Review Findings
- Health Canada reviewed the available information provided by foreign regulatory agencies, as well as from searches of the Canada Vigilance database, international databases and the scientific literature.
- At the time of the reviews, Health Canada identified 17 cases (15 Canadian and 2 international) of peripheral neuropathy in patients taking either vitamin B6-containing NHPs (14 cases) or vitamin B6-containing prescription drugs (3 cases). However, 15 of the 17 cases did not meet the criteria for further assessment to determine if there was a link. Though in the 2 remaining cases, which were in patients using vitamin B6-containing NHPs, further assessment was limited due to missing clinical information and the presence of confounders (other factors that may have contributed to the occurrence of peripheral neuropathy), such as the use of other supplements, the potential risk of peripheral neuropathy cannot be excluded.
- Health Canada also reviewed 9 articles published in the scientific literature, which supported a possible link between the use of vitamin B6-containing health products at daily doses as low as 10 mg vitamin B6 and the risk of peripheral neuropathy. Currently, no well characterized risk factors for developing peripheral neuropathy while using vitamin B6-containing health products have been identified.
- Both foreign regulatory agencies and international pharmacovigilance groups have identified cases of neuropathy with the use of vitamin B6-containing health products and, in some cases, established a possible link between peripheral neuropathy and vitamin B6-containing health products. Among the actions taken in response to their findings are:
- The TGA’s implementation of label updates for vitamin B6-containing health products to include the risk of peripheral neuropathy when the daily dose is over 10 mg of vitamin B6.
- The EFSA’s recommendation to lower the tolerable upper intake level of vitamin B6 to 12 mg/day for foods.
Conclusions and Actions
- Health Canada’s review found a possible link between vitamin B6-containing NHPs and the risk of peripheral neuropathy, when the daily dose is 10 mg vitamin B6 or higher.
- Health Canada will update the monograph for vitamin B6-containing NHPs to include the risk of peripheral neuropathy. Health Canada expects license holders 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.
- Health Canada does not recommend an update to the product safety information in the CPM for vitamin B6-containing prescription drugs at this time, as standardized prescription practices and monitoring of pregnant patients by healthcare professionals are already in place.
- Health Canada will also inform healthcare professionals and consumers about these updates through a Health Product InfoWatch communication and a social media campaign.
- Health Canada will continue to monitor safety information involving vitamin B6-containing products (NHPs and prescription drugs), as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action should new health risks be identified.
Please refer to the following website in Health Canada for details:
http://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1773147434487
In Hong Kong, there are registered pharmaceutical products containing vitamin B6 substance including pyridoxine, while there is no registered pharmaceutical product containing pyridoxal or pyridoxamine. So far, the Department of Health (DH) has received 8 cases of adverse drug reaction reports with regard to pyridoxine, but these cases were not related to peripheral neuropathy.
Related news regarding vitamin B6 and the risk of peripheral neuropathy was previously issued by TGA and Singapore Health Sciences Authority, and was posted on the Drug Office website on 5 May 2020, 5 Oct 2022, 15 May 2023 and 20 Feb 2026. Letters to inform local healthcare professionals were issued by DH on 5 Oct 2022. In Dec 2024, the Registration Committee of the Pharmacy and Poisons Board of Hong Kong discussed the matter, and decided that the sales pack labels and/or package inserts of registered products containing daily doses over 10mg of vitamin B6 should contain the warning statement related to peripheral neuropathy referenced in the above Health Canada announcement for vitamin B6-containing NHPs and the TGA announcement issued on 19 Feb 2026 “Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible (Contains vitamin B6)”. DH will remain vigilant on any safety update of the drugs issued by other drug regulatory authorities.
Ends/Saturday, May 2, 2026
Issued at HKT 14:30
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