Two more deaths linked to Kobayashi Pharma's red yeast supplements

Kobayashi Pharmaceutical confirmed Thursday two more deaths associated with its beni kōji red yeast rice dietary supplements. The company had already been linked to two prior deaths and over 100 hospitalizations in relation to the pills and kidney-related conditions, according to the health ministry, which held a hearing with the Osaka-based firm.

It is suspected that the health issues stem from a toxic, potentially mold-like substance in the products, but the company has yet to pinpoint a specific cause.

The health issues appear to be concentrated among those who ingested the supplements manufactured after September. Commonly reported symptoms include swelling, fatigue, and reduced kidney function.

An investigation into beni kōji began after a doctor reported health problems linked to the supplements in January.

Last Friday, Kobayashi Pharmaceutical announced it had received reports of illnesses associated with its products and initiated a voluntary recall of five items, including around 300,000 packages of its Beni Koji Choleste Help supplements.

On Wednesday, the Osaka city government issued a recall order for the three supplements subject to the voluntary recall and plans to issue a disposal order.

At the company's annual shareholders' meeting in Osaka on Thursday, President Akihiro Kobayashi acknowledged a series of issues, including the rising death toll.

He apologized, stating, "the entire company will do its utmost to prevent further damage and investigate the cause.”

This is his first public statement since the rapid spread of health issues from the supplements has come to light.

During the closed-door meeting, shareholders expressed concerns about the company's handling of the situation.

"I came here to ask the company to quickly investigate the cause of the health damage. I would like to hear how the company will deal with the situation and regain our trust," said a woman in her 60s from the city of Kashihara, Nara Prefecture, who has owned shares for more than 20 years.

A male shareholder in his 70s from Fujiidera, Osaka Prefecture, commented, "It is too late for the company to have not disclosed the health hazard, a whole two months after it was learned of in January. It casts doubt on the company's management practices.”

The meeting also discussed the appointment of president Kobayashi and seven other directors.

During a Thursday parliament session, Prime Minister Fumio Kishida also emphasized the urgency of the situation, saying "We must clarify the cause and consider all possible measures necessary.”

Beni kōji is believed to help reduce "LDL" or "bad" cholesterol in the blood but is also used in coloring and flavoring various products due to its distinctive red hue. In 2023, 16.1 tons of beni kōji were sold, of which 6.9 tons were used in supplements and other items. The company suspects a part of that 6.9 tons may have contained a harmful substance.

The health problem is already impacting the business.

From last Friday when the situation was publicly announced, to Thursday, Kobayashi Pharamaceutical’s stock price dropped around 20%, hovering around ¥4,900.

Kobayashi Pharmaceuticals intends to bear the cost of the voluntary recall of products containing the ingredient. The estimated total cost of the recall is ¥1.8 billion for itself and its 52 sales partners.

However, the financial burden may escalate significantly, especially when compensating affected consumers, according to the health ministry that also estimates there are at least 170 sales partners.

Sources said on Thursday that Kobayashi Pharmaceutical has expressed its intention via an email to compensate food makers and other business partners who purchased beni kōji as a raw material.

It is believed that Kobayashi intends to compensate for the decrease in sales, but the scope and timing of the compensation were not stated in the email.

The company will hold a news conference in the city of Osaka on Friday afternoon to provide further details from interviews with affected families.