其 他 安 全 警 示
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| Australia: Vitamin B6 (pyridoxine): Safety advisory: potential for dose-related adverse events (English only) |
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Therapeutic Goods Administration (TGA) announces that Vitamin B6, also known as pyridoxine, is commonly present in multivitamin and mineral preparations, vitamin B complexes, and in combination with magnesium.
A known side effect of vitamin B6 is peripheral neuropathy, which has symptoms of 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.
In Australia, 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: 'WARNING – Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. (Contains vitamin B6)'
Products containing 50 mg or less vitamin B6 are not currently required to display a label warning. This may make it difficult for consumers to identify reactions associated with vitamin B6, which could potentially lead to continued exposure and progression of neuropathy.
The TGA is aware of recent reports, both in Australia and overseas, which indicate that peripheral neuropathy may occur:
- at a daily dose of less than 50 mg a day of vitamin B6
- 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.
Information for consumers:
- They should be aware of the association between vitamin B6 and peripheral neuropathy, and that B6 may be in more than one of the products they take. Vitamin B6 might be listed on the label by one of its chemical names (pyridoxine hydrochloride, pyridoxal 5-phosphate or pyridoxal 5-phosphate monohydrate).
- If they take products that contain vitamin B6, be aware of symptoms of peripheral neuropathy, such as tingling, burning, or numbness. If they experience any of these symptoms, they should stop taking the product and seek medical advice.
- They should discuss any concerns or questions they have about this issue with their health professional.
Information for health professionals:
- They should be aware that peripheral neuropathy can occur at doses of less than 50 mg of vitamin B6 a day. Additionally, patients presenting with symptoms of peripheral neuropathy should be reviewed for vitamin B6 intake from sources such as B vitamins, multivitamins and/or magnesium products, particularly if taken in combination. When treating patients for peripheral neuropathy, they should consider whether a complementary medicine or dietary supplement could be involved.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/vitamin-b6-pyridoxine
In Hong Kong, there are registered pharmaceutical products containing vitamin B6 substances, including pyridoxine and pyridoxal. So far, the Department of Health (DH) has received 5 cases of adverse drug reaction related to pyridoxine, but these cases are not related to peripheral neuropathy. The DH has not received any case of adverse drug reaction related to pyridoxal. The risk of peripheral neuropathy associated with the use of vitamin B6 substances is documented in overseas reputable drug references such as the “Martindale: The Complete Drug Reference”. The DH will remain vigilant on safety update of the drugs issued by TGA and other overseas drug regulatory authorities.
Ends/Tuesday, May 5, 2020
Issued at HKT 15:00
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