Two deaths and more than 100 hospitalizations have been linked to growing health concerns in Japan over dietary supplements aimed at lowering cholesterol, the Japanese government said on Wednesday.
The authorities are investigating after non-prescription tablets were withdrawn by the Japanese company Kobayashi Pharmaceuticals after complaints of kidney problems from customers, according to what was reported by the “Kobayashi” website.South China Morning Post“.
The company recalled three supplement brands and other manufacturers whose products contain an ingredient called red yeast rice.
Red yeast rice, or “brown koji,” can cause organ damage depending on its chemical composition, medical research suggests. Research describes red yeast rice as an alternative to statins for lowering high cholesterol, but also warns of the risk of organ damage based on its chemical composition.
The total number of suspected deaths (now) is two,” chief government spokesman Yoshimasa Hayashi told reporters, while “106 cases of hospitalizations potentially linked to the substance have also emerged.”
Kobayashi Pharmaceuticals, which makes nutritional supplements, sells a wide range of health products marketed through television advertisements in Japan, and warned that it had not reached a conclusion about a causal link between health problems and its products.
It also supplies red yeast rice to about 50 other companies in Japan and two in Taiwan, the Osaka-based company says. Kobayashi Pharmaceuticals said it was aware of two deaths possibly related to the nutritional supplements it voluntarily recalled on Friday but declined to comment further.
Dozens of Japanese companies that used bene koji provided by Kobayashi Pharmaceuticals in their products also separately announced product recalls.
Affected products include various health tablets, as well as a pink fizzy drink, salad dressing, bread and miso paste used in many traditional dishes. Health Minister Keizo Takemi said Tuesday that the government had asked Kobayashi Pharmaceuticals to “immediately provide information” about the situation.
He added that the Ministry of Health “has issued instructions to local authorities throughout the country to collect information on health damage,” offering his condolences to those affected. Takemi added that authorities will consult with the company and a government meeting will be held this week “to discuss the status of the case and the need for a response.”
In Wednesday’s trading, Kobayashi Pharmaceuticals’ share price fell by 4 percent.
A day earlier, the drugmaker said the first person reported dead had regularly purchased one of the recalled products over a period of nearly three years. She offered her “deepest apologies” and said the link between the death and the product was being investigated. An analysis found the products likely contained “ingredients we did not intend to include,” the company said this week.
But her analysis found no citrinin produced by red yeast rice, which is toxic and can damage the kidneys.
According to a 2019 paper in the British Medical Journal, red yeast rice “is made by fermenting steamed rice with dietary fungi, 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 levels of a compound called monacolin K, which has the same structure as medically approved cholesterol medications.
“Red yeast rice products that contain large 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.
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