Therapeutic Goods Administration (TGA) has released a safety advisory on usage of Vitamin B6 (pyridoxine) containing medicinal products for an expected safety concern-Peripheral neuropathy.

Vitamin B6 is an essential nutrient widely distributed in various foods in different forms. It is commonly present in multivitamin and mineral preparations, vitamin B complexes, and in combination with magnesium for treatment of pyridoxine deficiency.

Peripheral neuropathy symptoms:

Tingling, burning or numbness, usually in the hands or feet. It usually occurs at high doses or following long-term use of products containing vitamin B6. Peripheral neuropathy is not associated with normal dietary intakes of vitamin B6.

Vitamin B6 is permitted for use in listed medicines containing daily doses of up to 200 mg. There are currently more than 1000 listed medicines in Australia that contain vitamin B6. However, due to the risk of peripheral neuropathy, products that contain more than 50 mg are required to have the following warning displayed on the product label (Not required for products containing vitamin B6 of <50 mg dose)-

‘WARNING – Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. (Contains vitamin B6)’

Consumers might find difficulty to identify adverse reactions associated with vitamin B6, which could potentially lead to continued exposure and progression of neuropathy. The TGA received recent case reports both of peripheral neuropathy associated with vitamin B6 at a daily dose of less than 50 mg a day and in consumers taking more than one product containing vitamin B6. The TGA is currently reviewing this issue and the outcome of this review may result in changes to the requirements for medicines that contain vitamin B6.

 Advise for Consumers/Patients:

Vitamin B 6 is present in medicinal product formulations in either of the below chemical names-

• pyridoxine hydrochloride
• pyridoxal 5-phosphate
• pyridoxal 5-phosphate monohydrate

All consumer and patients must be aware of safety concern, peripheral neuropathy associated with vitamin B6.  Consumers and patients should also be aware of the symptoms of peripheral neuropathy (tingling, burning, or numbness), when administered with Vitamin B6 products (or containing combinations).

Should stop the use of vitamin B6 products and seek medical advice, if any patient/consumer are experiencing the above specified symptoms. Discuss with symptoms and concerns with your health care professional.

Advise for Health Care Professionals:

All health care professionals should be aware of vitamin B6 associated peripheral neuropathy, which can occur even at doses of less than 50 mg of vitamin B6 a day.

Should monitor patients presenting with symptoms of peripheral neuropathy to look for a complementary medicine or dietary supplement.

Voluntary Reporting:

Health care professionals and consumers are advised to report any adverse reactions experienced with the use of this product to the TGA by online voluntary adverse event reporting facility available at TGA online adverse event reporting. This would facilitate in accumulation of the more evident safety data which could expedite the regulatory actions by TGA.