Sweeping vitamin B6 restrictions proposed

Sweeping changes to the way vitamin B6 products are accessed by patients could be on the way, following an interim decision released by the Therapeutic Goods Administration (TGA).
 
Under its proposal, products containing 50–200 mg of vitamin B6 could become pharmacist-only medicines, following mounting reports of toxicity diagnoses.
 
The risk of over-consumption is reiterated in the interim decision, laying out its concerns over the widespread availability of vitamin B6 from a variety of sources, including diet, fortified foods and supplements.
 
It can be found in more than 1000 listed medicines in Australia and consumed in food products including energy drinks, breakfast cereals and weight loss shakes.
 
The notice of interim decision, issued last week, came in response to an application to amend the current Poisons Standard in relation to pyridoxine, pyridoxal or pyridoxamine, which are different forms of vitamin B6.
 
Now open to public consultation, the document proposes a raft of changes to enhance safety and awareness amongst consumers, including restricting the sale of some preparations of products containing vitamin B6 to pharmacy-only.
 
‘The interim decision proposes to change the current scheduling of vitamin B6 (pyridoxine, pyridoxal and pyridoxamine) such that oral preparations containing 50 mg or less per recommended daily dose are available for general retail sale (unscheduled),’ a TGA spokesperson told newsGP.
 
‘Oral preparations containing more than 50 mg but less than 200 mg per recommended daily dose would become pharmacist-only medicines (Schedule 3).
 
‘This decision, if implemented, will reduce the maximum amount of vitamin B6 allowed in oral products than currently available for general sale.’
 
Last year, GP Dr Mary Buchanan spoke out about her long and painful journey living with vitamin B6 toxicity which, at its peak, left her struggling to walk even 100 metres.
 
It is a story all too familiar to GP and Chair of RACGP Specific Interests Obesity Management Dr Terri-Lynne South, who said the interim decision is positive news and provides multiple avenues to improve safety.
 
‘Any way that we can reduce the risk of excessive vitamin B6 needs to be supported,’ she told newsGP.
 
‘If this goes ahead, for higher preparations of vitamin B6 the consumer needs to have had a discussion with a pharmacist to access it.
 
‘But GPs need to understand that’s only one of three ways that people can be accessing B6.
 
‘Patients can still get multiple smaller amounts through lower dose products at less than 50 mg where they don’t need to have a conversation with a pharmacist, and they can still get it in complementary medicines and within food, such as energy drinks.’
 
This latest move follows a review by the TGA in 2022, which identified the risk of peripheral neuropathy occurring at doses less than 50 mg, and when people are taking multiple products containing vitamin B6.
 
The recommended dietary allowance of vitamin B6 varies depending on age and gender, ranging from 1 mg/day for children aged 9–13 years, to 1.7 mg/day for men older than 50 years.
 
Media coverage suggests the TGA has received 170 reports relating to peripheral neuropathy as a result of vitamin B6 poisoning since 2020.
 
In a bid to enhance safety and awareness of vitamin B6 toxicity, the TGA moved to strengthen labelling requirements so products containing daily doses over 10 mg must carry a warning about peripheral neuropathy.
 
This new interim decision builds further momentum towards this aim.
 
‘The interim decision balances the risks and benefits of using vitamin B6 including the risk of peripheral neuropathy, acknowledging its potential for irreversible harm at higher doses and variability in individual metabolism,’ the TGA spokesperson said.
 
‘It also considers the limited clinical need for supplementation due to dietary sufficiency, alongside the widespread use of vitamin B6 in fortified products and listed medicines.’
 
While the original application proposed tighter restrictions, suggesting preparations containing 5–200 mg be made available only on prescription, this was rejected by the delegate.
 
So too was the opinion of the Advisory Committee that ‘the current scheduling of pyridoxine, pyridoxal or pyridoxamine remains appropriate’.
 
Instead, the Advisory Committee recommended the TGA should consider education campaigns to increase public awareness of overconsumption, consistency in ingredient names on product labels, and strengthening labelling requirements either through stronger wording of warning statements or clarity on the presence of vitamin B6.
 
If the TGA’s interim decision is upheld after a period of public consultation, the changes are ear-marked for a February 2027 start.
 
‘After the public consultation on the interim decision closes on 27 July, the delegate will make a final decision. If the final decision is to amend the Poisons Standard, changes will come into effect on the implementation date in the notice,’ the TGA spokesperson said.
 
The interim report states that the ‘scheduling changes will impact more than 100 preparations currently listed in the [Australian Register of Therapeutic Goods] that provide more than 50 mg per RDD of vitamin B6’.
 
This excludes medicines containing vitamin B6 in combination with other active ingredients such as multivitamins.
 
‘Consequently, sponsors of these preparations will need to decide whether to continue marketing these products, reformulate the level of vitamin B6 to be 50 mg or below, or phase them out of the market,’ the interim decision said.
 
‘Any products that continue to include vitamin B6 between 50–200 mg will need to be evaluated as a registered medicine.’
 
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