TGA acts to address rising B6 overuse

From mid-2027, the availability of dozens and dozens of complementary medicines containing vitamin B6 will change. 

Yesterday (25 November 2025), the Therapeutic Goods Administration (TGA) released the final decision on the scheduling of vitamin B6 containing medicines in response to safety concerns following consideration of the advice of the Advisory Committee on Medicines Scheduling in November 2024 and public consultation. 

What’s changing?

The TGA Delegate’s final decision will see scheduling changes for products containing vitamin B6, dependent on the product’s vitamin B6 dose. This means oral preparations containing:

• 50 mg or less per recommended daily dose (RDD) will continue to be available for general retail sale (unscheduled)
• more than 50 mg but not more than 200 mg per RDD will be available as Pharmacist Only Medicines (Schedule 3)
• more than 200 mg per RDD will remain Prescription Only Medicines (Schedule 4).

When do the changes take effect?

The scheduling change will take place on 1 June 2027. 

What’s the concern about vitamin B6?

As reported previously in AP, high doses and/or prolonged use of vitamin B6 above the recommended daily intake (RDI) have been linked to peripheral neuropathy. Most cases have been reported at doses exceeding 500 mg/day, although cases at lower doses have been reported.1

The TGA’s adverse event notifications database now contains 250 reports1 of peripheral neuropathy, peripheral sensory neuropathy, small fibre neuropathy or chronic polyneuropathy for products containing vitamin B6.2

Between 1 January 2024 and 30 June 2025, the NSW Poisons Information Centre also received 14 calls from patients experiencing symptoms of neuropathy.2

The primary concern is the risk of overconsumption of vitamin B6 from a variety of sources, particularly in individuals using multiple multivitamin and supplement products.1 

How many products are affected?

There are at least 125 products on the Australian Register of Therapeutic Goods (ARTG) which contain more than 50 mg but less than 200 mg vitamin B6 (per maximum RDD). Of these, 116 are listed complementary medicines. These listed medicines will need to be registered on the ARTG and their labels updated to remain available on the Australian market after 1 June 2027. 

Will there be any other changes for vitamin B6 products?

We don’t know. The TGA has signalled they may implement further labelling changes e.g. to strengthen required warning statements or change how vitamin B6 is labelled on products.

The National Health and Medical Research Council will also undertake a review of the upper level of intake of vitamin B6, anticipated to be completed by early 2027. This may have a flow-on impact on this final scheduling decision. 

How will patients be informed of these changes?

The TGA intends to run a public awareness campaign to educate consumers about the multiple sources of vitamin B6 and possible harms from cumulative dose and excessive intake.

However, as with most health communication, health professionals – including pharmacists – will be the most important source of information for consumers.

The harms caused by excessive doses of vitamin B6 are concerning, and often occur through inadvertent dosing of multiple supplements or a false belief by consumers that complementary medicines are safe to use.

Pharmacists and pharmacy staff should be communicating now with patients about the risk of harm and safeguarding people from peripheral neuropathies and other complications from excessive vitamin B6 use.

References

1. Australian Government Department of Health, Disability and Ageing. Therapeutic Goods Administration. Notice of interim decision to amend (or not amend) the current Poisons Standard in relation to pyridoxine, pyridoxal or pyridoxamine (vitamin B6). 2025. At: www.tga.gov.au/sites/default/files/2025-06/notice-interim-decision-amend-or-not-amend-current-poisons-standard-pyridoxine-pyridoxal-pyridoxamine-vitaminb6.pdf
2. The therapeutic Goods Administration. Notice of final decision to amend (or not amend) the current Poisons Standard in relation to pyridoxine, pyridoxal or pyridoxamine (vitamin B6). At: https://www.tga.gov.au/sites/default/files/2025-11/notice-final-decision-to-amend-current-poisons-standard-pyridoxine-pyridoxa-pyridoxamine-vitamin-b6.pdf