Two deaths and more than 100 hospitalisations have been linked to a growing health scare in Japan around dietary supplements meant to lower cholesterol, the government said Wednesday.

Authorities are investigating after the over-the-counter tablets were recalled by Japanese drugmaker Kobayashi Pharmaceutical following kidney complaints from customers.

The company has recalled three supplement brands — “beni koji choleste help” and two other products — which contain an ingredient called red yeast rice, or “beni koji”.

Medical studies describe red yeast rice as an alternative to statins for lowering high cholesterol, but also warn of a risk of organ damage depending on its chemical make-up.

“The total number of suspected deaths (is now) two,” while “106 cases of potentially linked hospitalisation also came to light,” top government spokesman Yoshimasa Hayashi told reporters.

The supplement’s maker, Kobayashi Pharmaceutical, sells a wide range of health products marketed through television adverts in Japan, and has cautioned that it has not reached a conclusion on a causal link between the health problems and its products.

It has also supplied red yeast rice to around 50 other firms in Japan and two in Taiwan, the Osaka-based company says.

Kobayashi told AFP it was aware of two deaths possibly related to the supplements it voluntarily recalled on Friday, but declined to comment further.

Dozens of Japanese firms that used the beni koji provided by Kobayashi Pharmaceutical have also separately announced recalls.

The affected products include various health tablets, as well as a rose-coloured sparkling sake, salad dressing, bread and miso paste used in many traditional dishes.

– ‘Deepest apologies’ –

Health Minister Keizo Takemi said on Tuesday that the government had told Kobayashi Pharmaceutical to “promptly provide information” on the situation.

The health ministry has also “instructed local authorities nationwide to collect information on health damage”, he added, offering condolences to those affected.

In Wednesday trading Kobayashi Pharmaceutical’s share price dropped four percent.

The previous day, the drugmaker had said that the first person reported dead had regularly purchased one of the recalled products over the course of nearly three years.

It offered Its “deepest apologies” and said the link was being investigated.

An analysis found a possibility that the products contained “ingredients we had not intended to include”, the company said this week.

But its analysis did not find any citrinin produced by red yeast rice, which is toxic and can damage the kidneys.

Red yeast rice is “made by fermenting steamed rice with food fungus, and is often used to lower high cholesterol as an alternative to statin medication”, according to a 2019 paper in the British Medical Journal.

Concerns have been raised in the past over red yeast rice products that contain high levels of a compound called monacolin K, which has the same structure as medically approved cholesterol drugs.

“Red yeast rice products that contain significant amounts of monacolin K can have the same potential side effects as statin drugs, including muscle, kidney, and liver damage,” the US National Center for Complementary and Integrative Health says on its website. (AFP: Text, Excluding Headline)

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