Unintended substance confirmed in Japan's Kobayashi Pharma supplements

An unintended component called "puberulic acid" has been detected in products of Japanese drugmaker Kobayashi Pharmaceutical.

An unintended component called "puberulic acid" has been detected in products of Japanese drugmaker Kobayashi Pharmaceutical, the producer of red yeast rice dietary supplement known as "beni-koji," according to Japan's health ministry.

The findings, disclosed by the Osaka-based company during a panel of experts convened by the Ministry of Health, Labor and Welfare on Thursday, stated that puberulic acid, derived from blue mold, was identified in a batch of the supplements linked to health issues.

As of Friday, the products have been associated with five deaths and over 100 hospitalizations, with nearly 700 others seeking medical advice or planning to do so.

The hospitalized consumers are relatively concentrated in the age range of 40 to 70 years old, with the deceased aged between 70 to over 90 years old, according to the company.

However, the health ministry noted that puberulic acid is known for its antimalarial properties, but the extent to which its ingestion may pose health risks or cause kidney damage remains unclear.

The product linked to the deaths is named beni-koji choleste help, a type of granules advertised with the effect of lowering cholesterol levels manufactured at Kobayashi Pharmaceutical's Osaka factory.

Although the quantity is not substantial, the company exports some products to overseas markets, Akihiro Kobayashi, president and chief operating officer of Kobayashi Pharmaceutical, on Friday told a press conference held in the city of Osaka.

He added that there will be no differentiation in compensation for consumers both from home and abroad once the causal relationship is established.

Previously, the company suggested the potential presence of an unexpected mold-derived substance in batches of the product manufactured between April and December last year and initiated recalls of several products upon receiving reports of illness.

The mechanism by which this unintended substance was introduced into the product is yet to be determined, according to the health ministry and the company.

Special Reports