The Japanese government announced on March 27 that two deaths and over 100 hospitalisations have been connected to a rising health concern surrounding dietary supplements aimed at lowering cholesterol.
Authorities are currently investigating the matter after Japanese drugmaker Kobayashi Pharmaceutical recalled the over-the-counter tablets due to customer complaints regarding kidney issues.
Three supplement brands, including “beni koji choleste help,” have been recalled by the company.
These products contain an ingredient called red yeast rice, or beni koji.
Medical studies characterise red yeast rice as an alternative to statins for reducing high cholesterol levels.
However, they also caution about the potential risk of organ damage associated with its chemical composition.
“The total number of suspected deaths is now two,” stated top government spokesman Yoshimasa Hayashi, adding that “106 cases of potentially linked hospitalisation also came to light.”
Kobayashi Pharmaceutical, known for its extensive range of health products advertised on television in Japan, has cautioned that it has not yet established a causal link between the health issues and its products.
Additionally, the Osaka-based company disclosed that it has supplied red yeast rice to approximately 50 other firms in Japan and two in Taiwan.
Numerous Japanese firms that utilised beni koji supplied by Kobayashi Pharmaceutical have independently announced recalls.
The affected products encompass various health tablets, as well as a rose-colored sparkling sake, salad dressing, bread, and miso paste commonly used in traditional dishes.
On March 26, Health Minister Keizo Takemi announced that the government had directed Kobayashi Pharmaceutical to “promptly provide information” on the situation.
He also stated that the Health Ministry had instructed local authorities nationwide to gather information on health damage and offered condolences to those affected by the situation.
Commencing March 27, Kobayashi Pharmaceutical witnessed a 4 percent drop in its share price.
Just the day prior, the drugmaker disclosed that the initial reported fatality had been a consistent consumer of one of the recalled products for nearly three years.
Extending its “deepest apologies,” the company declared that the link was currently under investigation.
The company stated this week that an analysis revealed a possibility that the products contained “ingredients we had not intended to include.”
However, its analysis did not detect any citrinin produced by red yeast rice, which is toxic and can cause kidney damage.
According to a 2019 paper in the British Medical Journal, red yeast rice is “made by fermenting steamed rice with food fungus” and is frequently utilised as an alternative to statin medication for lowering high cholesterol levels.
In the past, concerns have been raised about red yeast rice products that contain elevated levels of a compound called Monacolin K, which shares the same structure as medically approved cholesterol-lowering drugs.
The US National Centre for Complementary and Integrative Health states on its website that “red yeast rice products containing significant amounts of Monacolin K can have the same potential side effects as statin drugs, including muscle, kidney, and liver damage”.
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