Japanese cholesterol-lowering supplements causes two death and 100 hospitalization

Two deaths and more than 100 hospitalizations have been linked to a health scare in Japan involving cholesterol-lowering supplements, the government said Wednesday.

Authorities are investigating after the over-the-counter tablets were recalled by Japanese drugmaker Kobayashi Pharmaceutical after customers complained of kidney problems. The company has recalled three brands of supplements—”beni koji choleste help” and two other products—that contain an ingredient called red yeast rice, or beni koji.

Medical research describes red yeast rice as an alternative to statins for reducing high cholesterol, but also warns of the risk of organ damage depending on its chemical composition. The total number of suspected deaths (now) is two,” while “106 potentially related hospitalizations have also emerged,” government spokesman Yoshimasa Hayashi told reporters.

The company that makes the supplement, Kobayashi Pharmaceutical, sells a wide range of health products marketed through television advertisements in Japan and warned that it had not reached a conclusion on a causal link between the health problems and its products.

A market in chaos

The company also supplied red yeast rice to about 50 other companies in Japan and two in Taiwan. As a result, dozens of Japanese companies that used the koji raw material supplied by Kobayashi Pharmaceutical in their products have separately announced recalls. Affected products include various health pills, as well as a pink sparkling sake, salad dressings, bread and miso paste used in many traditional dishes.

Health Minister Keizo Takemi said Tuesday that the government has ordered Kobayashi Pharmaceutical to “immediately provide information” on the situation. He also “ordered local authorities nationwide to collect information on health damage,” he said, offering his condolences to those affected.

The day before, the pharmaceutical company said the first person to die 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 the possibility that the products contained “ingredients we did not intend to include,” the company said this week. But the analysis did not find citrinin, produced by red yeast rice, which is toxic and can damage the kidneys.

Red yeast rice is “produced by fermenting steamed rice with a food fungus and is often used to reduce high cholesterol as an alternative to statin drugs,” according to a 2019 article in the British Medical Journal. Concerns have been raised in the past about red yeast rice products that contain high levels of a compound called monacolin K, which has the same structure as doctor-approved anti-cholesterol drugs.
“Red yeast rice products that contain significant amounts of monacolin K may have the same potential side effects as statin drugs, including muscle, kidney, and liver damage,” the U.S. National Center for Complementary and Integrative Health says on its website.