The TGA has announced certain preparations of medicines containing pyridoxine, pryidoxal or pyridoxamine will no longer be available for general purchase.
Health professionals have been urged to review vitamin B6 intake in their patients as the Therapeutic Goods Administration prepares to implement the rescheduling of certain vitamin B6-containing medicines.
The TGA has recommended clinicians assess patients’ use of vitamin B6 and remain alert to the significant symptom overlap between vitamin B6 toxicity and 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,” the TGA said.
Earlier this month the TGA announced that certain medications containing vitamin B6 will be rescheduled as Pharmacist Only Medicines from 1 June 2027.
Specifically, oral preparations containing more than 50mg but less than 200mg of vitamin B6 in each recommended daily dose will only be available over the counter after seeking the advice of a pharmacist.
Preparations containing 50mg or less per daily dose will remain available for general retail sale, while people seeking medications containing more than 200mg per recommended daily dose will continue to require a prescription.
“Vitamin B6 can cause peripheral neuropathy, and while the risk is greatest for higher intakes of vitamin B6, it cannot be excluded for doses less than 50 mg/day,” the TGA noted in its statement.
“It can be difficult for consumers to estimate their vitamin B6 intake because of the widespread presence of vitamin B6 in listed medicines and food supplements and the different ways vitamin B6 is labelled on products.”
Vitamin B6 toxicity is associated with peripheral neuropathy, seborrheic dermatitis, glossitis (inflammation of the tongue), confusion and seizures. Delayed diagnosis and continued exposure to vitamin B6 can result in symptoms continuing to progress.
“From the final decision document, as of 31 October 2025, there were 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,” the TGA said.
“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, burning sensation etc. possibly suggestive of neuropathies.”
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Estimates suggest that the average requirement for vitamin B6 among Australian adults is 1.1 to 1.3mg/day, with the recommended dietary intake being 1.3 to 1.7mg/day.
The TGA’s announcement is the result of a 15-month journey, after the Advisory Committee on Medicines Scheduling received an application to amend the Poisons Standard to address the potential vitamin B6 issues in November 2024. An interim decision was released in June 2025, with the final decision released in November.
The TGA reported that there were more than 125 medicines on the Australian market containing more than 50mg but less than 200mg per maximum recommended daily dose when they released their final decision, with 116 of these listed as complementary medicines.
“The scheduling for vitamin B6 intersects with other regulatory controls which also require changes following the scheduling decision,” the TGA concluded.
“Additional recommendations for improved consumer safety are also under consideration. The rescheduling implementation date of 1 June 2027 allows for necessary regulatory and industry changes.”
Read the full update from the TGA here.
