‘A long time coming’: TGA clamps down on vitamin B6

Tighter restrictions on products with vitamin B6 are coming into force, as the Therapeutic Goods Administration (TGA) moves to address longstanding concerns about the vitamin’s potential to cause nerve damage when taken at high doses.
 
Late on Tuesday, the regulator announced that products with a recommended daily dose of 50–200 mg of the vitamin will only be available over the counter with advice from a pharmacist from June 2027.
 
Products containing more than 200 mg per recommended daily dose remain prescription-only while those with less than 50 mg can still be sold at general retail outlets.
 
The decision, which was flagged in June pending public consultation, follows 250 reports of neuropathy-related adverse events for products with vitamin B6 up to 31 October this year.
 
Of those, 208 were since 1 January 2023, including 130 so far this year.
 
A TGA report outlining the reasoning behind the decision also notes 14 calls to the NSW Poisons Information Centre from patients with neuropathy symptoms, including two people taking 50 mg or less of pyridoxine daily.
 
‘The considerable number of adverse events, difficulties in diagnosis and ensuing hardships on sufferers justify the scheduling restrictions on vitamin B6 medicines available for general sale,’ it said.
 
It also suggests ‘there is sufficient evidence to conclude peripheral neuropathy may occur in some individuals with vitamin B6 intake of 50 mg/day or even lower’ and notes the adverse event reports ‘contrast with industry submissions claiming that neurological adverse events from vitamin B6 only occur at high dose and with long-term usage’.
 
Following the announcement, the TGA will also run a public awareness campaign to educate consumers about the multiple sources of vitamin B6 and possible harms from cumulative dose and excessive intake.
 
For Hobart-based GP and accredited dietitian Dr Sarah Edwards, the change has been ‘a long time coming’.
 
‘It’s a good step in the right direction for making the community aware of what might be in their supplements,’ she told newsGP.
 
‘It does stretch beyond just what we’re seeing on the shelves in the chemist, and in the real world we’re seeing quite a bit of the peripheral neuropathy and the sequelae of B6 toxicity.’
 
Dr Edwards describes the case of one of her patients presenting with peripheral neuropathy who was eventually found to have ‘extremely elevated’ levels of B6.
 
‘She’d been taking her magnesium supplements for her restless legs and zinc because she thought it was healthy and had no idea that there were large amounts of B6,’ she said.
 
‘Being elderly, you’re probably not going to be clearing it as quickly as someone who’s a bit younger.
 
‘It is a water-soluble vitamin, but if you’re having an excess day, after day, after day, then you do have that cumulative effect, and it can build up to toxic levels.’
 
While the symptoms improved, they did not completely resolve, leading Dr Edwards to suspect her patient has suffered permanent damage.
 
It echoes the account of GP Dr Mary Buchanan, who previously shared her story with newsGP to raise awareness of the potential risks of B6 toxicity when she became ill due to magnesium supplements.
 
According to the TGA, many individual accounts it received during public consultation said medical professionals did not initially recognise B6 toxicity as the cause of their symptoms, ‘resulting in significant delay to diagnosis, cost and personal adversity’.
 
It says there are currently ‘at least 125’ products containing between 50–200 mg of vitamin B6 per maximum recommended daily dose, including 116 listed as complementary medicines.
 
The regulator notes that vitamin B6 deficiency is ‘uncommon among the Australian population’, with an average adult requirement for vitamin B6 of 1.1–1.3 mg per day, and a recommended dietary intake for a healthy adult of 1.3–1.7 mg/day.
 
The vitamin, otherwise known as pyridoxine, pyridoxal and pyridoxamine, is contained in thousands of other products, including medicines, supplements, energy drinks and weight loss shakes.
 
The TGA report notes that tolerable upper limit for vitamin B6 in adults aged 19 years and older is set by the National Health and Medical Research Council (NHMRC) at 50 mg/day. This is currently under review, with the results due to be published in early 2027.
 
‘Should there be a change following the NHMRC review, the appropriateness of the new limits in this final decision will be re-evaluated,’ the TGA report states.
 
As awareness of B6 toxicity has grown, so has the number of people seeking tests.
 
Dr Edwards, however, warns against unnecessary interventions with patients.
 
‘If they’re not presenting with any symptoms of peripheral neuropathy or burning or tingling, then you don’t really need to go and test for it,’ she said.
 
‘If they’re not necessarily symptomatic, if they are taking a lot of supplements, then educate them and reduce the supplements that they’re taking.
 
‘Supplements are very unregulated and really unnecessary, there’s little evidence base for a lot of what people are taking.’
 
The TGA last strengthened its approach towards vitamin B6 when it changed labelling requirements in 2022, mandating a warning about peripheral neuropathy on products with daily doses over 10 mg.
 
Its move this year to change the Poisons Schedule was backed by the RACGP, which also recommends ‘health claims made on vitamin B6 containing products be subject to stronger regulations and permitted only when robust evidence demonstrates the benefits clearly outweigh the potential risks’.
 
For RACGP President Dr Michael Wright, the confirmation of tighter restrictions is welcome news.
 
‘So many of us have started to notice patients presenting with neuropathic symptoms and it is really important that this increasingly common form of nerve damage is recognised and stopped,’ he told newsGP.
 
‘The fact that there’s a time delay will give us time to make sure we’re all fully prepared before these changes kick in.’
 
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