Japan’s Kobayashi Pharmaceutical now probing 80 deaths over possible link to benikoji red yeast supplement

Tokyo — Japanese health supplement maker Kobayashi Pharmaceutical said Friday it was probing 76 more deaths possibly linked to its tablets containing red yeast rice, meant to lower cholesterol. It deepens a scandal that erupted earlier this year when the company said it was looking into five deaths potentially linked to the over-the-counter products after dozens of customers reported kidney problems.

Fermented with a mould culture, red yeast rice, or “benikoji,” has been used in food, alcoholic drinks and folk medicines for centuries around East Asia.

“Even if the direct cause of hospitalisation or death was not kidney-related disease, it has become clear that there are a variety of cases, including cases in which benikoji-related products may have caused harm somehow and had some indirect impact,” a Kobayashi statement said.

Of the five initial deaths under investigation, the company said it now knows one did not consume red yeast rice.

“We have received 1,656 inquiries from individuals who have sought medical attention, and have 76 cases under investigation over (a causal) connection to the deaths,” in addition to the original four, it said.

Japan Drug Supplement Recall
Akihiro Kobayashi, President of Kobayashi Pharmaceutical Co., left, bows during a press conference in Osaka, Japan, March 22, 2024. 

Chiaki Ueda/AP

On March 22, Kobayashi Pharmaceutical said it was recalling three kinds of tablets containing benikoji. It later said it had detected a potentially toxic acid produced by the mould at one of its factories, and government officials inspected the firm’s facilities.

Kobayashi Pharmaceutical is a household name in Japan, offering a wide range of health-related products, and the scandal has been top news in the country.

On Friday, Kobayashi said it would work to identify the exact cause and scope of the health damage — including whether organs other than kidneys were harmed.

Top government spokesman Yoshimasa Hayashi said Friday that the health ministry had previously ordered the company to file a daily report on its probe, and demanded more details earlier this month after the number of deaths under investigation didn’t change.

“But until today, it had not reported the specific number of cases under investigation, and it is extremely regrettable,” Hayashi told reporters.

Kobayashi Pharmaceutical has said it also sold red yeast rice to around 50 other firms in Japan and two in Taiwan.

Taiwanese companies preventively recalled 154 products containing red yeast rice in the wake of the scare, the island’s health authorities said earlier this year.

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