Supplements containing 200mg or more of vitamin B6 will become S4 medicines in June 2027, while those containing 50-200mg will go behind the pharmacy counter, the TGA says.
The 50mg cut-off for when a pharmacist or doctor must be involved is based on NHMRC guidance on the safe daily upper limit for consumption, the medicines watchdog says.
Despite this, it says it has also identified cases of B6 neurotoxicity involving less than 50mg a day.
Overall, the TGA says it has identified more than 100 cases of B6 neurotoxicity, including cases of peripheral neuropathy, nerve damage and muscle weakness that had “significant impacts on daily life and employment”.
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