Japan recalls health supplement linked to two deaths and over 100 hospitalisations

This comes as a major Japanese drugmaker on Tuesday (Mar 26) said that it is investigating the death of one person who is believed to have regularly consumed a health supplement, advertised as a cholesterol-lowering pill, containing a type of yeast-fermented rice called beni kōji.

A second death was reported to the Ministry of health, labour and welfare, Kyodo news agency reported.

Company issues apology

The Osaka-based Kobayashi Pharmaceutical said that they were investigating the death and hospitalisations linked to the product which contains the ingredient, as many people reported developing kidney problems after taking the supplement.

The company also said that they had recalled the product and urged people to stop taking the supplements as they suspect a causal link between the product and the death, which reportedly occurred due to kidney disease.

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The person who died had been buying Kobayashi Pharmaceutical’s Beni-koji Cholesterol Help supplement, advertised as a cholesterol-lowering pill, continuously for three years starting April 2021 and ordered over 35 bags until last month.

“We have always placed the health of our customers above all else as our top priority. We would like to express our sincerest apologies for the circumstances that led to this incident,” said Kobayashi Pharmaceutical in an apology issued on its website, as quoted by the Japan Times.

The company said that it suspects that the problem could be previously undetected toxic substances in moulds used during production.

“Although we are diligently confirming the facts and causal relationships, we would like to report this from the perspective of prompt information disclosure,” said the company.

The customers affected by the product reported reduced kidney function, change in the colour of their urine, swelling in limbs and fatigue.

The company, on Monday (Mar 25) had also reported that around 26 people had been hospitalised for kidney-related and other health problems after taking the supplements containing beni kōji.

According to Japanese media reports, millions of these health supplements have been sold since the pill was introduced in early 2021.

In January, Kobayashi Pharmaceutical said that they began an investigation and set up a hotline for consumers after a doctor alerted them.

What is beni kōji?

Beni kōji is a type of rice which is fermented using monascus purpureus – a species of reddish-purple mould that gives the rice its distinct dark red colour.

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It is believed that this type of rice can help reduce LDL or “bad” cholesterol in the blood. Beni kōji is also used in several products to add colour and flavour.

On Monday, the company which also supplies beni kōji to food and beverage companies asked them to recall products containing the ingredient.

Kobayashi Pharmaceutical, according to Japanese media, has provided beni kōji as a food ingredient to 52 companies in Japan and abroad.