An unintended component called “puberulic acid” has been detected in dietary supplements produced by Japanese drugmaker Kobayashi Pharmaceutical, according to Japan’s health ministry. The discovery has been linked to five deaths and over 100 hospitalizations, prompting a nationwide investigation.
The Osaka-based company disclosed during a panel of experts convened by the Ministry of Health, Labor and Welfare on Thursday that “puberulic acid”, derived from blue mold, was identified in batches of their red yeast rice dietary supplement known as “beni-koji.” The specific product implicated is “beni-koji choleste help,” granules advertised to lower cholesterol levels.
As of Friday, nearly 700 individuals have sought or are planning to seek medical advice related to the consumption of these supplements. The hospitalized consumers are predominantly between the ages of 40 and 70, while the deceased were aged between 70 and over 90, according to company reports.
While “puberulic acid” is known for its antimalarial properties, health officials noted that the extent to which its ingestion may pose health risks or cause kidney damage remains unclear. The mechanism by which this unintended substance was introduced into the product is still under investigation by both the health ministry and Kobayashi Pharmaceutical.
Akihiro Kobayashi, president and chief operating officer of Kobayashi Pharmaceutical, addressed the media on Friday in Osaka, stating that although the quantity of exported products is not substantial, there will be no differentiation in compensation for affected consumers at home and abroad once a causal relationship is established.
Previously, the company suggested the potential presence of an unexpected mold-derived substance in batches manufactured between April and December of the previous year. Following reports of illness, Kobayashi Pharmaceutical initiated recalls of several products.
The incident has raised concerns among health officials and consumers alike, highlighting the importance of stringent quality control in pharmaceutical manufacturing. Further investigations are underway to determine the source of contamination and implement necessary safety measures.
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Unintended substance found in Kobayashi Pharma's supplements in Japan
cgtn.com