Japanese Supplement Linked to 80 Deaths

A Japanese pharmaceutical company is investigating 80 deaths possibly linked to its supplement.

This is a staggering increase from five deaths the company, Kobayashi Pharmaceutical, reported in March, according to the New York Times.

CholesteHelp, the red yeast rice supplement, is intended to help reduce cholesterol levels. Japanese government officials said the supplement was found to contain puberulic acid, a highly toxic compound derived from blue mold.

Since March, 1,656 people have sought medical advice for supplement-related health concerns, and 289 people have been hospitalized, according to Kobayashi Pharmaceutical.

Japanese health minister Keizo Takemi said it was “extremely regrettable” that Kobayashi Pharmaceutical had not informed the ministry sooner about the rising number of deaths and pledged that the government would become more involved in the investigation.

Founded in 1919, Kobayashi Pharmaceutical sells a wide variety of products, including air fresheners, oral hygiene products, and lens cleaners.

Meanwhile in Taiwan, more than 30 victims filed a class-action lawsuit against the drugmaker’s Taiwan subsidiary, the Japan Times reports.

What is red yeast rice?

Red yeast rice is produced by the fermentation of a fungus on rice, usually Monascus purpureus. Technically, M. purpureus is a mold rather than a yeast, but dietary supplement labels in the United States typically use the name “red yeast rice” instead of “red mold rice.”

The fungus can enrich the rice with substances known as monacolins, including monacolin K, which is structurally identical to the statin drug lovastatin.

European regulators concluded in 2018 that exposure to monacolin K from red yeast rice could lead to severe adverse effects, such as on the liver and rhabdomyolysis, a rare muscle injury leading to the breakdown of muscles.

However, a 2019 review of clinical trials suggests that red yeast rice products with varying levels of monacolin K are safe.

Supplements need to be better regulated

The CholesteHelp case may serve as a dire warning to the U.S., where the Food and Drug Administration does not have the authority to approve dietary supplements for safety and effectiveness.

The lack of oversight has already allowed toxic products to enter the market. In 2019, a young woman experienced acute liver failure, requiring a life-saving liver transplant. Doctors attributed the condition to a weight loss supplement she had previously been taking for months.

Weight-loss supplement OxyElite Pro was linked to 97 cases of acute non-viral hepatitis, resulting in 47 hospitalizations, three liver transplants, and one death in 2014.

In 2020, the American Medical Association (AMA) called for more stringent federal regulation of dietary supplements, including increased oversight of manufacturing, marketing, product labeling, and adverse event reporting.

The AMA said in a statement, “While reports estimate that 75,000 new dietary supplement products have been introduced since 1994, the U.S. Food and Drug Administration has only received adequate safety data for fewer than 250 new ingredients and has no mechanism to know all of the products on the market or their ingredients.”


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