The statement comes after the Spanish government says more than a dozen people were hospitalised due to online vitamin D supplements.
The Therapeutic Goods Administration has responded to reports of a spate of Vitamin D overdoses in Spain with reassurance that vitamin products in Australia are closely monitored.
Spain’s Ministry of Health warned of the risks of taking vitamin D without medical supervision, after 16 people in the Balearic Islands were admitted to hospital for hypervitaminosis D after taking a supplement purchased online.
The Balearic Islands’ Food Safety Service said the otherwise healthy patients presented with abdominal pain, nausea and vomiting, and were diagnosed with acute renal failure, hypercalcemia and high serum vitamin D levels.
In Australia, there are limits on the permitted vitamin D content in listed medicines in Australia of 25 micrograms per maximum recommended daily dose, with strict quality controls in place for all medicines, a spokesperson for the Therapeutic Goods Administration said.
There have been 10 adverse even reports between 1981 and 30 July 2025 relating to vitamin D, according to the Database of Adverse Event Notifications (DAEN), the spokesperson said.
“We do not currently have any post-market safety investigations underway involving vitamin D in Australia,” they said.
“However, we monitor the safety of all medicines as part of our routine pharmacovigilance activities.”
The reports come after access to large doses of vitamin B6 was restricted in Australia following an increase in adverse events related to peripheral neuropathy.
In June, the TGA made an interim decision to amend the Poisons Standard to classify supplements containing 50-200mg/day of B6 as schedule 3 pharmacy-only medicines.
“Vitamin B6 can be consumed at doses higher than the recommended daily intake, including through the consumption of a variety of supplement products,” the TGA said.
“Predominantly high doses and/or prolonged use has been linked with peripheral neuropathy. However, there are case reports at low doses and consensus regarding a safe threshold is lacking.”
