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B6 Toxicity – TGA Asleep at the Wheel – again

Danny Vadasz

22 July 2025

While we champion the value of supplementation for healthy ageing, this blog will always emphasise the need for guidance from your GP and the dangers of self-medication.


I couldn’t think of a better vindication for this cautionary approach than the alarming recent reports of unintended overdosing of vitamin B6.  Equally alarming is that this has occurred right under the nose of the regulator that’s supposed to protect us from harmful medical practices - the Therapeutic Goods Administration.


Australia’s pharmaceuticals regulator, the Therapeutic Goods Administration (TGA) has finally acted to address the serious problem of vitamin B6 toxicity caused by inadvertent overdosing.


At last count, the TGA has received over 170 adverse event reports relating to patients who have unwittingly consumed dangerous amounts of B6 through its undeclared presence in other products. Given that only a tiny fraction of adverse events are ever reported, health experts predict this is only the tip of a disturbing iceberg.


Vitamin B6 (pyridoxine) is essential for metabolism, brain function, and immune health. It is often prescribed therapeutically to remedy PMS, mood support, or homocysteine regulation However, the recommended daily intake (RDI) for adults is 1.3–1.7 mg/day and this can be easily achieved through a normal, balanced diet that includes meat, fish, vegetables and cereals.


When taken in excess, B6 can lead to serious health problems including peripheral neuropathy (most commonly observed as burning, tingling or numbness of fingers or toes), muscle weakness and other forms of neuropathy (nerve damage).


What makes this overdosing more insidious is that it is not due to conscious consumption but due to the hidden presence of B6 in a range of over-the-counter supplements and functional foods. For instance, B6 is often added to Magnesium supplements where its concentration may reach as much as 50–60 mg per pill.


Apart from Magnesium, B6 is often included in Zinc and Multivitamin supplements. It can also be found in energy drinks and protein shakes, herbal blends and even in weight loss products.


Exacerbating the problem is the fact that you may not even recognise that you are taking B6 as it can be listed under its less common identifiers pyridoxine, pyridoxal, and pyridoxamine.


What makes this avoidable health crisis even more disappointing is that the TGA has known of these potential dangers since at least 2020 when it was reported that a businessman, Paul Torrisi, had experienced severe symptoms after taking multiple supplements to boost immunity during the COVID pandemic. He unknowingly consumed B6 from a multivitamin, zinc plus, and magnesium tablets—leading to seven times the normal blood level.


In fact, the problem was first documented way back in the mid-1980s, when British researchers Dalton & Dalton published findings that 40–60% of women taking B6 at doses over 50 mg/day for premenstrual syndrome, showed signs of toxicity.

 

The TGA has issued an interim decision to strengthen labelling requirements to clearly identify B6 and warn of nerve damage. It will also reclassify products with more than 200 mg as Prescription Only.


Most significantly, the TGA will reclassify products with more than 50 mg B6 as Pharmacist Only Medicines. However, in a deferral that appears to protect manufacturers from expensive write-offs rather the general public from harm, these reclassifications will only take effect from Feb 2027. You may well ask why.


In the meanwhile, you will have to rely on your own vigilance rather than the regulator’s duty of care to ensure you don’t become a victim of unintended overdosing.


For those for whom it is too late, a class action on behalf of affected consumers is being considered by Victorian legal firm Polaris Lawyers.

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