This is more than the total number of adverse event reports received in the whole of last year, where 193 cases were reported.
The TGA was responding to queries from NutraIngredients amid ongoing public attention on vitamin B6 and adverse side effects such as peripheral neuropathy.
In the past week, vitamin B6 was thrust into the spotlight following news of a potential class action against major dietary supplement company Blackmores.
A law firm, Polaris Lawyers, claimed that lead plaintiff Dominic Noonan-O’Keeffe has been experiencing neuropathy caused by “excessive B6 levels” in the Blackmores supplements that he was taking.
One of the supplements mentioned, Blackmores Super Magnesium +, contains 60.78mg of pyridoxine hydrochloride — a form of vitamin B6.
This is within the current limits permitted by the TGA, where listed or “low risk” complementary medicines can contain a maximum permitted daily dose of vitamin B6 at 100mg for adults.
Peripheral neuropathy is one of the common side effects of excessive vitamin B6 levels.
However, this is tricky as deficiency in B6 levels could also be associated with peripheral neuropathy, the TGA said in its interim decision to lower the recommended daily dose of vitamin B6 in listed medicines to 50mg.
Other side effects of excessive B6 levels include nausea and insomnia.
“From 1 January to 30 June 2025, the TGA received a total of 239 adverse event reports for medicines containing vitamin B6. In 2024, we received 193 reports for B6 products.
“Many of these products contain multiple ingredients, and some of the reports might be related to ingredients other than B6,” said the TGA.
The TGA said that the adverse event reports received came from all sources, including consumers, and did not include ‘complaints’ related to things other than adverse events.
Last year, 41 out of the 193 cases were related to reports of peripheral neuropathy, peripheral sensory neuropathy, small fibre neuropathy or chronic polyneuropathy.
Between January 1 and June 4 this year, 54 such cases had been received.
The TGA added that adverse event notifications are publicly available on Database of Adverse Events Notifications (DAEN) – Medicines.
“To search for reports for products containing B6, search for ‘pyridox’ — which will capture the various B6 ingredients.
“It is important to note that reporting of an adverse event to the TGA or publication in DAEN does not necessarily mean that a causal link with the medicine is established.
“Further information about DAEN, including advice on interpreting the data and limitations of the data, is available on our website,” said the TGA.
Actions and public education
The TGA said it has strongly encouraged and actively promoted adverse event reporting among health professionals and consumers.
“Reporting serious adverse events is mandatory for the companies that supply therapeutic goods,” it said.
“We strongly support the Advisory Committee on Medicines Scheduling (ACMS) recommendation on education campaigns to inform consumers about risks of high or prolonged intake,” it added.
Yesterday (July 27), it also ended a public consultation on its interim decision to lower the maximum recommended daily dose (RDD) of vitamin B6 in listed medicines to 50mg.
If approved, the policy will take effect from February 1, 2027.
This follows TGA’s decision back in March 2022, where medicines providing over 10 mg equivalent of vitamin B6 per day are required to state the label warning statement: “WARNING – Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].”
Other initiatives include publishing information on its website alerting consumers to the risk of neuropathy, and also running a public awareness campaign on understanding complementary medicines.