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A rise in B6 toxicity cases led to the TGA review, with changes being brought in from June 2027
The Therapeutic Goods Administration (TGA) has responded to a rise in vitamin B6 toxicity cases by strengthening safety controls for all products containing it.
Australia’s medicines regulator will bring in the changes from 1 June 2027 to give industry and clinicians time to make necessary changes such as updating labels, managing stock and complying with the new scheduling rules.
It’s hoped the changes will reduce the risk of nerve damage associated with long term consumption of B6 at high doses.
The TGA decision was based on a robust review, including public consultation showing strong support for tighter controls from almost 250 public submissions.
The review found that 103 people have reported severe and sometimes permanent health effects from vitamin B6 toxicity, including peripheral neuropathy, nerve damage, muscle weakness, and significant impacts on daily life and employment.
While low doses of vitamin B6 will continue to be available, any products containing higher doses will require pharmacist supervision or a prescription from a doctor. Some supplements will be removed from the shelves altogether.
Oral preparations containing 50mg or less of vitamin B6 will still be available for general retail sale, while those between 50mg and 200mg per daily dose will be available over the counter but only with the advice of a pharmacist. Any with more than 200mg of vitamin B6 per recommended daily dose will require a doctor’s prescription.
The TGA found that the number of adverse events, along with the difficulty of diagnosis and the hardships many people were suffering as a result, justified the new restrictions. The body will run a public awareness campaign to educate consumers about the risks.
Vitamin B6 is water soluble and is sold under names such as pyridoxine, pyridoxal, pyridoxamine and their respective phosphorylated forms.
The vitamin supports the immune system by helping to make antibodies to fight off infections, and is needed to produce haemoglobin.
It is commonly found in high doses either directly as a pure vitamin or as a component in supplements and in fortified foods. It’s also used as an additive in thousands of products including medicines, multivitamins and mineral supplements, energy drinks and weight loss shakes.
While some women take B6 supplements during pregnancy or to help with premenstrual syndrome, most people don’t need or gain benefit from a B6 supplement.
Three side effects to watch out for from B6 toxicity, are numbness in the feet and hands, difficulty with balance and coordination because of muscle weakness, and heartburn and nausea. Doctors are advised they should inquire about use of over-the-counter preparations as a possible cause of any neuropathic symptoms they are presented with.
Pharmaceutical companies are also being encouraged to warn consumers of the potential side effects, including nerve hyperexcitability.
According to research published in the Medical Journal of Australia, complementary medicines are used by more than half the people in Australia and questions are being raised as to whether more regulation is needed for the sector.
Women use complementary medicines more than men, and almost 75 per cent of healthy Australians over 70 report using complementary medicines daily or occasionally.
Nance Haxton was a journalist at the ABC for nearly 20 years. She’s also worked as an Advocate at the Disability Royal Commission helping people with disabilities tell their stories and as a senior reporter for the National Indigenous Radio Service.
In that time she’s won a range of Australian and international honours, including two Walkley Awards, and three New York Festivals Radio Awards trophies.
Now freelancing as The Wandering Journo, Nance is independently producing podcasts including her personal audio slice of Australia “Streets of Your Town”.
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