Safety of medication of vitamin B6: A systematic review / 中国药学杂志

ABSTRACT

OBJECTIVE: To evaluate the safety of medication of vitamin B6. METHODS: Clinical studies involving vitamin B6 were searched from PUBMED, EMBASE, Cochrane Library(2014,06), LILACS and four Chinese databases, CBM,CNKI,VIP and WANFANG. National drug administration websites were also been searched. Two authors independently extracted and evaluated the included studies. Causality assessment of an adverse drug event was performed with the WHO-UMC system. RESULTS: A total of 2 582 literatures were searched and 27 were included involving 805 patients. Randomized controlled trials concluded that there was no significant difference between oral use of vitamin B6 and comparison group in the incidence of adverse event. Cohort studies concluded that there was no dose-response relationship between oral vitamin B6 30-230 mg and adverse drug reaction. Case series studies, case reports and websites information concluded that the most common adverse reactions of vitamin B6 were numbness and other peripheral neuropathy. CONCLUSION: Serious adverse drug reactions may occur irrespective of oral and intravenous use of vitamin B6, such as drug-induced liver damage and allergic shock. Common adverse reactions such as peripheral neuropathy needed to be closely monitored especially when overdose used.