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Amid a vitamin B6 crackdown, the TGA is warning of a paradox where common symptoms of toxicity are similar to those of B6 deficiency.
The TGA says adverse event reports suggest ‘a lack of awareness’ remains among consumers about the presence of vitamin B6.
The Therapeutic Goods Administration (TGA) is continuing to gear up for changes to the way patients access vitamin B6, advising doctors to remain vigilant for symptoms of toxicity.
Oral preparations containing more than 50 mg but not more than 200 mg per recommended daily dose of vitamin B6 will be rescheduled as Pharmacist Only Medicines from 1 June 2027.
Products with 50 mg or less per recommended daily dose of vitamin B6 will continue to be available for general retail sale, and preparations containing more than 200 mg will continue to require a prescription.
While regulatory changes do not take effect until mid-next year, the TGA says health professionals can ‘take action now’ to consider vitamin B6 toxicity in patients presenting with symptoms of peripheral neuropathy.
‘A review of the patient’s vitamin B6 intake is recommended, paying close attention to potential sources such as B vitamins, multivitamins and magnesium and zinc products, particularly when taken in combination,’ the TGA advised.
‘Various food and beverages supplemented with vitamin B6 should also be taken into consideration when estimating a person’s total vitamin B6 intake.
‘Health professionals should be alert to the paradox that the most common symptoms associated with vitamin B6 toxicity are similar to those of vitamin B6 deficiency.
‘Therefore, it is important to be aware that consumers may inadvertently exacerbate the symptoms they are trying to treat by taking supplements containing vitamin B6.’
Consumers’ lack of awareness of the presence of vitamin B6 in medicines, particularly if the label lists the chemical name without the common name, was also flagged as a concern. The TGA confirmed it is currently considering recommendations on ways to make this clearer.
‘Health professionals should be alert to this as consumers may not recall use if asked, leading to delayed diagnosis and medicine cessation,’ the TGA advised.
‘Delayed diagnosis and continued exposure can lead to progression of the disease.’
The TGA also drew attention to adverse event reports that suggest a lack of awareness that vitamin B6 can cause peripheral neuropathy.
Since 1 March 2022, medicines containing daily doses of vitamin B6 more than 10 mg or equivalent have been required to carry a safety warning.
As of 31 October 2025, the TGA had received 250 reports of peripheral neuropathy, peripheral sensory neuropathy, peripheral sensorimotor neuropathy, small fibre neuropathy, polyneuropathy or chronic polyneuropathy for products containing vitamin B6 on the TGA’s Database of Adverse Event Notifications.
Of these, 152 also reported ‘hypervitaminosis B6’ and/or ‘vitamin B6 increased’.
There were another 162 reports of ‘hypervitaminosis B6’ and/or ‘vitamin B6 increased’ with less specific reaction terms such as paraesthesia and burning sensation, ‘possibly suggestive of neuropathies’, the TGA flags.
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B6 TGA Therapeutic Goods Administration vitamin B6 deficiency
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