According to Japanese news media Kyodo News, four people are believed to have died and over 100 hospitalized after consuming red yeast rice dietary supplements from Kobayashi Pharmaceutical Co., the Japanese drugmaker and the health ministry said Tuesday, amid swelling safety concerns over the products.
One person was reported by the Osaka-based drugmaker to have died from kidney disease after apparently taking the “beni-koji” supplements for around three years. A second death was reported to the Ministry of Health, Labor and Welfare following a hearing with the company.
The number of people hospitalized after taking the supplements has jumped to 106, and the government has said it will conduct emergency checks on a type of food touting health benefits under the responsibility of producers, a category that includes some 6,000 products.
The fatal case reported earlier was the first known death with a possible link to supplements containing red yeast rice after Kobayashi Pharmaceutical last week voluntarily recalled five products, including about 300,000 packages of “beni-koji choleste help” that was labeled as helpful in lowering cholesterol.
The individual is said to have ordered a total of 35 “choleste help” packages on a regular basis from April 2021 to February 2024, the company said, adding that it is examining the causal relationship between ingestion and the person’s death in February.
The company was notified of the death via an email from the family on Saturday, it said. But it was only on Monday that it noticed the message because it was flooded with a massive number of inquiries from the public.
The company met with bereaved family members in the first reported death on Tuesday as it seeks to confirm the individual’s symptoms and other details regarding how the supplement was consumed.
According to Kobayashi Pharmaceutical, the problematic batch of beni-koji was manufactured at a factory in Osaka.
The second death was confirmed after the health ministry and the Consumer Affairs Agency conducted a hearing with officials from the pharmaceutical company to ascertain whether it has appropriately responded to the cases in line with the law.
Kobayashi Pharmaceutical has requested all companies supplied with its beni-koji to voluntarily recall products that use the same ingredient, with the incident affecting a wide range of products including sake, confectionery, bread and miso.
The nationwide voluntary recall has been extended to include food items and seasonings that feature beni-koji as an ingredient, as it is used for various purposes such as coloring and flavoring.
Photo taken March 26, 2024, shows Kobayashi Pharmaceutical Co.’s factory in Osaka. (Kyodo)
In China, online sales of products subject to the drugmaker’s voluntary recalls have been suspended, local media said. Products have also been removed from circulation in Taiwan.
Chinese media have pointed to the possibility that the fermentation process of beni-koji may produce the toxic substance citrinin that could lead to kidney disease, but Kobayashi Pharmaceutical has said the ingredient produced by the company does not contain citrinin.
据日本药企小林制药和卫生部门周二表示，两人据信在食用小林制药公司的红曲米膳食补充剂后死亡，超过100人住院，而对这些产品的安全性担忧正在加剧。
据这家总部位于大阪的药企报告，一人服用“红曲”补充剂约三年后因肾脏疾病而死亡。据卫生、劳动和福利部称，第二起死亡案例是在与该公司进行听证会后向部门报告的。
服用这些补充剂后住院的人数已经增至106人，政府表示将对一类由生产商负责的号称具有健康益处的食品进行紧急检查，该类别包括约6000种产品。
早些时候报告的致命病例是小林制药上周自愿召回了五种产品之后与含有红曲米的补充剂可能有关的首例死亡。
据该公司称，这名个体从2021年4月至2024年2月定期订购了共35个“胆固醇助手”包装，该公司正在调查服用和死亡之间的因果关系。
该公司称，家属于周六通过电子邮件通知了死亡事件，但直到周一才注意到该信息，因为公众的询问数量庞大。
该公司于周二与报告的第一起死亡的家属会面，以确认个体的症状以及有关补充剂的消费方式的其他细节。
根据小林制药的说法，红曲米的问题批次是在大阪的一家工厂生产的。
卫生部和消费者事务机构在与制药公司官员进行听证会后确认了第二起死亡案例，以确定该公司是否根据法律适当地应对了这些案例。
小林制药已要求所有供应其红曲米的公司自愿召回使用相同成分的产品，此事件影响了广泛范围的产品，包括日本清酒、糖果、面包和味噌。
全国性的自愿召回已扩展至包含以红曲米为成分的食品和调味料，因为它被用于各种用途，如着色和调味。
据中国媒体称，在中国，受制药公司自愿召回的产品影响，网上销售已暂停。产品也已从台湾的市场中撤出。
中国媒体指出，红曲米的发酵过程可能产生毒性物质柠檬酸酪氨酸，可能导致肾脏疾病，但小林制药表示，该公司生产的成分不含柠檬酸酪氨酸。
据小林制药中国方面表示，召回产品是因为“在部分红麹原料中可能含有非预期的成分”；自主召回的三款产品均未在中国大陆市场上市销售，相关产品“通过跨境渠道销往中国大陆”。
及至目前，相关病例仅出现在日本国内。但召回事件的发生及发酵，或将影响中国消费者对这一日本老牌网红保健品牌的认可度。这家从制药拓展至保健品的日本“百年老店”，凭借爆款单品的打造，2023年销售额突破1734.55亿日元（约合82亿元人民币）。
早在2015年，乘着海外代购的流行之风，小林制药在日本境内面向中国游客的销售额就达到43亿人民币（约2亿元人民币）。2023年，其在中国的销售收入增至136亿日元（约合6亿元），从体量来看，中国已成为其海外第二大市场。近年来，小林制药也在持续加码在中国的投资。
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