Japan drugmaker links death to red yeast pill

A major Japanese drugmaker has said it is investigating a death that could be linked to its red yeast rice pills - which were recalled earlier last week.

More than 26 people were hospitalised after taking the beni kōji fermented rice products, the firm says.

Kobayashi Pharmaceutical reported the injuries last week after issuing a voluntary recall of five products.

The firm urged customers to stop using the pills, which were as advertised as cholesterol-lowering supplements.

Kobayashi said it suspected that the problem may have come from previously undetected toxic substances in moulds used in production.

Beni kōji is rice fermented with monascus purpureus, a species of reddish-purple mould. While advertised as a health supplement for high cholesterol and blood pressure, it's also widely used as a traditional colour dye for food products.

On Tuesday, the company issued a statement announcing the "causal relationship" of its Red Yeast Cholesterol Help product and the customer's death.

It said it had received a message from the bereaved family saying the person had died from kidney disease and had been using the Red Yeast Cholesterol Help product these past three years. The firm said there had been a regular mail order.

"Although we are diligently confirming the facts and causal relationships, we would like to report this from the perspective of prompt information disclosure," Kobayashi said.

"Our company has always prioritised the health of our customers above all else and we sincerely apologise for this situation."

Affected customers had reported symptoms such as changes in the colour of urine, swelling in their limbs and fatigue.

The company had opened an investigation after a doctor alerted them to reported health problems in January. It has since established a hotline for customers.

Its Red Yeast Cholesterol Help product debuted on store shelves in February 2021. The company has so far sold more than a million packets of it, Japanese media reported.

The firm has also supplied beni kōji as a food ingredient to food and beverage makers around the world and warned companies of the risk last week.

None have reported any customer injuries so far. But one major beverage maker, Takara Shuzo Co, announced it would recall a sparkling sake product that had been coloured with the supplied beni kōji.