THE ASAHI SHIMBUN
May 29, 2024 at 16:14 JST
Toxic puberulic acid found in Kobayashi Pharmaceutical Co.’s dietary supplements that led to widespread health damage can cause renal tubular necrosis, the health ministry said, citing animal experiments.
Ministry officials said May 28 they suspect that blue mold, which generates the acid, accidentally came to be mixed in during the cultivation process of “benikoji” red yeast rice.
According to the Japanese Society of Nephrology, many people who fell ill after ingesting Kobayashi Pharmaceutical’s benikoji supplements are suspected of having developed Fanconi syndrome, which is caused by renal tubular damage.
The company previously said puberulic acid, a toxic natural compound known as an antibacterial agent, was discovered in the supplements in question, but its effects on kidney function were unknown.
As of May 27, five people had died after taking one of the three types of supplements being recalled, and 281 others had been hospitalized, according to the health ministry.
In the production of the supplements’ ingredients, rice planted with Monascus purpureus, a type of mold called “benikoji-kin” in Japanese, is cultivated, heated and pulverized.
When puberulic acid or the supplements were given to rats, their renal tubular necrotized, the health ministry said.
However, the ministry said it has yet to study effects on kidney function when low concentrations of puberulic acid are administered repeatedly.
Ministry officials said they are still unable to conclude that the acid caused the health damage.
The ministry also said two other substances found in ingredients produced between June and August 2023, when many people reported health problems, suggest that blue mold got into the mix.
It said the substances are believed to have been generated when benikoji-kin was cultivated together with blue mold.
Kobayashi Pharmaceutical’s aging factory in Osaka, where the affected ingredients were produced, was shut down in December, and a subsidiary’s factory in Wakayama Prefecture took over production.
Blue mold has been found at both plants.
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Kobayashi Pharmaceutical Co.’s Benikoji Coleste Help, a supplement containing the benikoji ingredient (Provided by the company)
