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Drug Safety

, Volume 41, Issue 9, pp 859–869 | Cite as

Vitamin B6 in Health Supplements and Neuropathy: Case Series Assessment of Spontaneously Reported Cases

  • Florence van HunselEmail author
  • Sonja van de Koppel
  • Eugène van Puijenbroek
  • Agnes Kant
Original Research Article

Abstract

Introduction

In the literature, vitamin B6 has been linked to the development of polyneuropathy. Most often, these complaints were seen when taking high doses of vitamin B6 for a long time. Evidence as to whether a lower dosage range of vitamin B6 (< 50 mg/day) can also induce neuropathy is scarce.

Objective

We aim to comprehensively describe the cases of neuropathy associated with vitamin B6 received by the Netherlands Pharmacovigilance Centre Lareb and to assess the case series concerning the use of vitamin B6 and neuropathic complaints.

Methods

We describe the number and nature of the reported cases, including suspect product, dosage, duration of use, and vitamin B6 serum levels. In addition, we describe the causality for the individual cases (Naranjo Probability Scale) and for the entire case series (Bradford Hill criteria).

Results

In total, 90 reports on products containing vitamin B6 included at least one adverse drug reaction in the standardized Medical Dictionary for Regulatory Activities (MedDRA®) query (SMQ; broad) ‘peripheral neuropathy’. The amount of vitamin B6 in the products varied between 1.4 and 100 mg per tablet. The serum vitamin B6 level was known in 36 cases (88–4338 nmol/l), and the mean serum vitamin B6 level was 907 nmol/l. However, no statistical correlation between dosage and vitamin B6 blood levels was found.

Discussion and Conclusion

Causality assessment of the case series of 90 reports to Lareb shows it is plausible for the vitamin B6 supplements to have caused complaints such as neuropathies. This is especially the case with higher dosages and prolonged use, but dosages < 50 mg/day also cannot be excluded.

Notes

Compliance with ethical standards

Conflict of interest

Florence van Hunsel, Sonja van de Koppel, Eugène van Puijenbroek and Agnes Kant have no conflicts of interest.

Funding

No sources of funding were used to assist in the preparation of this study.

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Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Netherlands Pharmacovigilance Centre Lareb’s-HertogenboschThe Netherlands
  2. 2.Department of Pharmacy: Pharmacotherapy and Pharmaceutical CareUniversity of GroningenGroningenThe Netherlands

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