A nationwide recall of a dietary supplement that lowers cholesterol has been issued in Japan amid concerns it could be linked to two deaths and more than 100 hospitalisations, according to news agency Kyodo.
Kobayashi Pharmaceutical, which sells over-the-counter drugs and dietary supplements, has issued a national recall of the product, and authorities are conducting emergency checks on thousands of products that advertise their health benefits, Kyodo reported.
The three recalled brands – “beni koji choleste help” and two similarly named supplements – contain an ingredient called red yeast rice, or “beni koji”. Made by fermenting rice, it is said to lower levels of bad cholesterol.
The Osaka-based drugmaker reported one of the deaths, saying the person had regularly bought “beni-koji” for nearly three years and died of kidney disease.
“We’re now aware of one instance where there is a potential causal link between a death and our product,” the company said in a statement. “We are currently investigating the link, and what happened,” it added, offering its “deepest apologies”.
A second death was reported to the Ministry of health, labor and welfare after a hearing with the company, Kyodo reported.
“The total number of suspected deaths [is now] two”, while “106 cases of potentially linked hospitalisation also came to light”, top government spokesman Yoshimasa Hayashi told reporters.
Kobayashi Pharmaceutical said it supplied red yeast rice to about 50 other firms in Japan and two in Taiwan. The ingredient can also be used in a range of products including sake, confectionery, bread, miso and seasoning.
Online sales of the recalled products have been suspended in China, and removed from circulation in Taiwan, according to Kyodo.
Health minister Keizo Takemi said the ministry “will cooperate with Osaka city to investigate the cause … and prevent further health-related damage”.
The company voluntarily recalled its products on Friday after customer complaints about kidney problems.
It said on Monday that it had not reached a conclusion on a link between the health problems and its supplements. However, analysis had found a possibility that the products contained “ingredients we had not intended to include”, it said.
The fermentation process can produce a toxin called citrinin which can damage the kidneys, however, the company said its analysis did not detect any citrinin.
With Agence France-Presse