ISSUE 2 FEBRUARY
Reproduced with permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 19 February 2026.
Summary
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.
Vitamin B6 is also known as pyridoxine, pyridoxal, or pyridoxamine.
The effect of the TGA's decision is that from 1 June 2027 products with low doses of vitamin B6 will continue to be available for general sale, while products containing higher doses will require advice from a pharmacist or a prescription from a doctor, depending on the dose:
- oral preparations containing 50 mg or less per recommended daily dose will continue to be available for general retail sale.
- oral preparations containing more than 50 mg but not more than 200 mg per recommended daily dose will be available over the counter with the advice of a pharmacist.
- oral preparations containing more than 200 mg 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. 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.
The scheduling for vitamin B6 intersects with other regulatory controls which also require changes following the scheduling decision. 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.
What health professionals should do
While the implementation date for these regulatory changes is not until 1 June 2027, 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 [which may also contain vitamin B6], particularly when taken in combination. 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.
Adverse event reports submitted to the TGA suggest there is a lack of awareness that vitamin B6 can cause peripheral neuropathy. Most consumers who use complementary medicines perceive these medicines to be safe and effective.
Adverse event reports also suggest a lack of awareness about the presence of vitamin B6 in medicines, particularly if the label lists the chemical name without the common name 'vitamin B6'. Health professionals should be alert to this as consumers may not recall use if asked, leading to delayed diagnosis and medicine cessation.
Following the scheduling decision, we are considering recommendations on ways to make it clearer for consumers that vitamin B6 is present and how much is in the medicine.
There are currently three forms of vitamin B6 in low-risk products available in the Australian market through self-selection:
- pyridoxine hydrochloride
- pyridoxal 5-phosphate
- pyridoxal 5-phosphate monohydrate.
When included as active ingredients, pharmaceutical companies must list these names on the label.
Where a label is not available for the medicine, formulation details of medicines that can be supplied within Australia can be found by searching the Australian Register of Therapeutic Goods (ARTG). The available PDF summary will list the vitamin B6 ingredient, if present, using one of the above names and state how much is in the medicine as the equivalent amount of pyridoxine.
See the full article on the TGA website.
