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Policy
High-dose ‘pyridoxine’ to be classified as an Rx drug
by Lee, Hye-Kyung Feb 14, 2022 05:54am
The high-dose Vitamin B6 ‘Pyridoxine Hydrochloride 300mg’ is likely to be classified as a prescription drug. Although pyridoxine doses up to 250mg are classified as a health functional food abroad, experts reached a consensus that the 300mg dose of the same drug should be classified as a prescription drug in consideration of the side effects that arise from the long-term use of the higher dose, and similar cases where a low-dose formulation of an approved drug had been classified as an OTC and the high-dose formulation as an ETC. The Ministry of Food and Drug Safety disclosed the minutes of the meeting held by the drug classification subcommittee of the pharmaceutical policy committee under the Central Pharmaceutical Affairs Council that was held on January 17th. In Korea, pyridoxine may be taken up to 100mg as an OTC, up to 250mg under the Korean manufacturing standard for medicine, and up to 67mg as a health functional food. The product that was under review this time is a high-dose formulation that contains 300mg of pyridoxine. Other than in Japan which classified the 300mg high-dose formulation as a prescription drug, other countries have classified the same drug as a health functional food or OTC. However, the subcommittee members were skeptical about the classification of high-dose pyridoxine as an OTC due to concerns over its side effects and duration of use. In particular, the members reached a consensus that it is reasonable to classify the high-dose formulation as a prescription drug as the high-dose pyridoxine is used for conditions that require diagnosis, such as to prevent deficiencies arising from the administration of Vitamin B6 antagonists and the treatment of B6 dependence, in addition to well as the side effects that may arise. Also, some raised the opinion that the 300mg needs to be classified as an ETC for the safe use of the drugs in consideration of cases where the lower dose was approved as an OTC and the higher dose was approved as ETC. Regarding its efficacy and effect, some members pointed out that although the 300mg formulation is not expected to be sold as a nutritional supplement the standard between the health functional food and OTC was unclear as the same ingredient is approved as a health functional food up to 67mg/day, and as OTC up to 100mg/ day. To the question where dosages other than the 300mg high-dose formulation that is under review may be reviewed for classification as OTC/ETC, the MFDS responded that such cases would require a separate application for review. As a result, the MFDS voted to classify pyridoxine 300mg as a prescription drug with consensus from the committee members.