TGA Responds to Rising Concerns Over Nerve Damage
The Therapeutic Goods Administration (TGA) is reviewing the Poisons Standard in Australia following mounting evidence that excessive intake of Vitamin B6 (pyridoxine), especially from supplements, can lead to peripheral neuropathy, a form of nerve damage that causes numbness, tingling, and burning sensations in the hands and feet. People can get B6 through supplements, as well as complementary medicines and within foods, such as energy drinks.
What’s more? The recommended intake of B6 is 1.3–1.7 mg/day for adults; however, most supplements contain 10mg, and some 50mg or more. Most Australians meet their B6 needs through diet alone (see image for foods that contain B6). Also, note that Vitamin B6 interacts with Parkinson’s medications.
What Is Peripheral Neuropathy?
- Caused by Vitamin B6 toxicity, particularly from supplements exceeding safe levels.
- Symptoms include tingling, numbness, burning pain, and in severe cases, difficulty walking or muscle weakness.
- Some people may develop symptoms even at lower doses or after long-term use.
Current Labelling Requirements
- Products with more than 10mg/day of Vitamin B6 must carry a warning about peripheral neuropathy.
- However, many consumers remain unaware of the risks, especially when taking multiple supplements that cumulatively exceed safe limits.
Proposed Changes to the Poisons Standard
The TGA’s interim decision includes:
| Proposed Amendment | Description |
|---|---|
| Schedule 3 Reclassification | Oral preparations with >50mg but <200mg of B6 to become Pharmacist Only Medicines |
| Labelling Enhancements | Stronger warnings and clearer identification of B6 on packaging, including all chemical names (e.g., pyridoxine hydrochloride) |
| Schedule 4 for High-Dose Products | Products with >200mg/day to require a prescription |
Public Consultation
- The TGA is accepting submissions until July 27, 2025.
- Consumers, health professionals, and industry stakeholders are encouraged to provide feedback via the TGA consultation hub.
Individual Risk Factors
- No universal safe threshold: Some people experience toxicity at doses below 50mg/day.
- Risk increases with multiple supplement use, even if each product contains a low dose.
What Should Supplement Users Do?
- Check labels for all forms of B6: pyridoxine, pyridoxal, pyridoxamine. Especially in those vitamins and supplements that say “B-complex” and “executive B” formulas. Don’t forget to check other complementary therapies and energy drinks!
- Calculate total daily intake across all supplements.
- Watch for symptoms like tingling or numbness and stop use if they appear.
- Request a Home Medicines Review (HMR) from your pharmacist or GP to assess supplement safety and interactions.
- Consult a health professional before starting or continuing ANY supplements. Supplementation is generally only advised for those with diagnosed deficiencies through a blood test or GP’s recommendations.
Interaction With Parkinson’s Medications
Yes! Vitamin B6 can interfere with levodopa, a key medication for Parkinson’s. High doses of B6 may increase peripheral metabolism of levodopa, reducing its effectiveness unless taken with carbidopa.
For detailed documentation, see:
- Vitamin B6 and Levodopa Interaction Guide
- Drugs.com overview of B6 and Parkinson’s medications
- TGA interim decision on B6
- RACGP Sweeping vitamin B6 restrictions proposed
If you’re unsure whether your supplements are safe or necessary, a Home Medicines Review is a great first step. Ask your GP for a referral and a pharmacist can come to your home and review all the medications, vitamins and supplements you take. And if you’re managing Parkinson’s, be especially cautious as B6 might be doing more harm than good.
