TOKYO, March 27 — Two people were reported to have died and more than 100 people were hospitalized in Japan today in connection with growing health concerns over a cholesterol-lowering dietary supplement.
The drug company at the center of the concern, Kobayashi Pharmaceutical, told AFP it was aware of two deaths that may have been linked to its non-prescription pills.
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The company has recalled three brands of supplements that contain an ingredient called red yeast rice, or “red yeast rice,” including “red yeast rice cholesterol help” and two other products.
Medical research describes red yeast rice as an alternative to statins for lowering high cholesterol, but also warns of the risk of organ damage depending on its chemical composition.
Kobayashi Pharmaceutical Co. announced Tuesday that it is aware of a total of 75 hospitalizations related to its products, which were recalled following kidney complaints from customers.
Multiple Japanese media reports say the number has now increased to 106, but neither the pharmaceutical company nor the Ministry of Health, Labor and Welfare could immediately confirm the latest numbers.
The company warned that it had not reached a conclusion on a causal relationship between the health problems and the supplements it voluntarily recalled on Friday.
The Osaka-based company, which sells over-the-counter medicines and supplements, said it also supplies red yeast rice to about 50 other companies in Japan and two in Taiwan.
Dozens of Japanese companies that used red yeast rice provided by Kobayashi Pharmaceutical in their products also announced individual recalls.
These include rosy sparkling sake, salad dressings, breads, a “miso” paste used in traditional cooking, and a variety of health tablets.
“I need an answer.”
Health, Labor and Welfare Minister Keizo Takemi said on Tuesday that the government had instructed Kobayashi Pharmaceutical to “promptly provide information” about the situation.
The Ministry of Health, Labor and Welfare also stated, “We have instructed local governments across the country to collect information on health hazards,” and expressed their sympathies to those affected.
Authorities will consult with the company and a government meeting will be held this week “to discuss the circumstances of the incident and the need for a response,” Takemi added.
Kobayashi Pharmaceutical’s stock price fell 4% in Wednesday trading.
A day earlier, the drug company announced that the person whose death was first reported had regularly purchased one of the recalled products for nearly three years.
The company said in a statement that it is “currently aware of a case where there is a potential causal relationship between a death and our product.”
“We are currently investigating the relationship and what happened,” he added, adding, “We deeply apologize.”
The company announced that an analysis revealed that the product may contain “ingredients that were not intended to be included.”
However, that analysis did not detect citrinin, which is produced by red yeast rice, which is toxic and can damage the kidneys.
According to a 2019 paper published in the British Medical Journal, red yeast rice is “made by fermenting steamed rice with edible bacteria and is often used to lower high cholesterol as an alternative to statin drugs.”
Concerns have been raised in the past about red yeast rice products containing high concentrations of a compound called monacolin K, which has the same structure as medically approved cholesterol drugs.
The US National Center for Complementary and Integrative Medicine says on its website, “Red yeast products containing high amounts of monacolin K may have potential side effects similar to those of statins, including damage to muscles, kidneys, and liver. “It has said.