Health Kobayashi Pharma confirms fatality linked to red yeast supplement

Today, Kobayashi Pharmaceutical Co. revealed that their malted rice ingredient, benikōji (紅麹, red yeast), has been linked to a customer's death. The Osaka-based drug maker also reported 50 new cases of hospitalisation related to benikōji consumption, in addition to the 26 previously confirmed cases, most of which involved kidney problems. The deceased customer, whose gender and age remain undisclosed, passed away due to kidney disease while hospitalised in February. The company stated that the customer had purchased the dietary supplement Benikoji Coleste Help between April 2021 and February 2024.

The person, whose place of residence, gender and age were not disclosed, purchased a total of 35 packages of the company's supplements containing "beni-koji" red yeast rice that have been recalled due to reports of kidney and other health problems. The person bought "beni-koji choleste help" on a regular basis by mail order from April 2021 to February 2024, the Osaka-based company said, adding it is examining the causal relationship between ingestion and death. The company was informed of the person's death via an email from the deceased's relatives on Saturday, it said.

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Kobayashi Pharmaceutical said it had discovered an "unintended, unknown substance" in the benikoji used in the supplements. The company said that the product purchased by the deceased person may have contained this substance.





On a side note: sake brewery Takara Shuzō pulled nearly 100,000 bottles of sparkling sake from shelves due to a risk of kidney damage linked to the beverage's alluring pink colour. The brewery announced the recall of about 18,000 750-millilitre bottles and 78,000 300-ml bottles of Mio Premium Rose on 23 March. The sparkling sake's fetching rose hue comes from benikōji malted grain, recalled by its manufacturer, Kobayashi Pharmaceutical Co., the day before. Although no health problems have been reported with Mio Premium Rose since its launch in January, Takara Shuzō is withdrawing the sake at the pharmaceutical company's request.

After a second person died and 106 were hospitalized after ingesting Kobayashi Pharmaceutical Co.'s supplements, the Osaka Municipal Government, where the company is based, issued an order to destroy three products containing benikoji: "Benikoji coleste-help," "Naishi-help plus cholesterol" and "Natto-kinase sarasara-tsubu gold," all of which are dietary supplements made with benikoji as an ingredient.





According to the Food Safety Commission, there have been reports of health problems in Europe that are suspected to have been caused by consuming supplements derived from rice fermented with benikoji.

In 2014, the European Commission, which is responsible for the administration of the European Union, set standards and regulated supplements for citrinin, a toxic chemical produced by the benikoji bacteria. In 2019, the standard was further lowered and regulations were tightened. In 2014, Switzerland banned the sale of food products containing benikoji, and France urged people to consult their doctors before using such supplements.

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So far, six fatalities have been reported over the benikoji supplements: five in Japan and one in Taiwan.

Osaka-based Kobayashi Pharmaceutical, the company behind the products, also recorded some 12,000 cases of users complaining about health problems, it said during a press conference on Friday. The 114 hospitalized are between 40 and 80 years old, it added. [...] The Ministry of Health on Wednesday told stores to dispose of all stock of Benikoji ColesteHelp, NaishiHelp Plus Cholesterol and Natto-kinase Sarasara Tsubu GOLD as it investigates Kobayashi Pharmaceutical's products.

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