Credit: https://www.kobayashi.co.jp/

On May 28th, Japan's Minister of Health, Labour and Welfare, Keizo Takemi, announced that after consulting with experts in related fields, it has been largely determined that the problematic red yeast rice ingredient produced by Kobayashi Pharmaceutical contains puberuic acid, which can cause kidney-related health issues.

In addition to puberuic acid, tests on samples have also identified the presence of two other previously unknown compounds. Takemi explained that these substances are presumed to be byproducts introduced by Penicillium during the cultivation of red yeast rice.

According to data from Japan's Ministry of Health, Labour and Welfare, as of May 27th, five consumers who took health supplements containing red yeast rice from Kobayashi Pharmaceutical have died, over 1,600 people have sought medical treatment, and more than 280 individuals have been hospitalized.

The number of casualties related to red yeast rice incidents

Credit: https://www.kobayashi.co.jp/

Incident Review

On March 22, Kobayashi Pharmaceutical announced on its website that some consumers who had taken their health supplements containing red yeast rice had developed kidney disease and other symptoms.

According to Kyodo News, Kobayashi Pharmaceutical initially received complaints about the adverse health effects of red yeast rice products on January 15. On February 6, the company reported to President Akihiro Kobayashi that multiple individuals were suspected of suffering health issues due to these supplements. It wasn't until March 22 that Kobayashi Pharmaceutical publicly disclosed the safety concerns and announced an allocation of 1.8 billion yen (approximately 90 million RMB) to recall over 300,000 products. The recalled items include “Red Yeast Rice Cholesterol Reduction Granules,” “Visceral Fat Reduction + Cholesterol Reduction Granules,” and “Nattokinase Refreshing Granules GOLD,” all aimed at improving cholesterol levels.

On April 9, the Japanese Society of Nephrology released a summary report of an investigation into 95 cases of health damage related to Kobayashi Pharmaceutical supplements. The report indicated that among the 95 individuals, 29 were male and 66 were female. Most of these individuals suffered from Fanconi syndrome, a disorder affecting kidney tubule function.

What is Penicillic Acid?

Penicillic acid is a natural compound discovered in 1932 as a secondary metabolite of the fungi Penicillium puberulum and Penicillium aurantio-virens. It belongs to a class of compounds known as highly oxygenated tropolones.

Penicillium toxins are notably heat-resistant, meaning their toxicity remains even after cooking. These toxins primarily affect vital organs. Research has shown that long-term consumption of feed contaminated with penicillin-like toxins can lead to liver enlargement, liver cell degeneration, and inhibition of DNA synthesis in animal cells. In severe cases, it can cause DNA fragmentation in animal cells. However, reports of kidney toxicity caused by penicillic acid are still rare and require further investigation to establish a clear connection.

Red yeast rice, Image by Freepik

Can red yeast rice produce citrinin?
During the fermentation process, red yeast rice does not produce citrinin. Experts suggest three main possibilities for the presence of citrinin in Kobayashi Pharmaceutical's red yeast rice products: 

          first, contamination during production; 

          second, the introduction of microorganisms capable of producing citrinin; 

          or third, a mutation in the red yeast strain that allows it to generate citrinin.

Regardless of the cause, these possibilities indicate serious drug safety issues at Kobayashi Pharmaceutical.

Drug safety is paramount, and pharmaceutical companies must always prioritize consumer health and safety by enhancing product quality control and safety oversight. Consumers should also exercise caution when purchasing and using health supplements, opting for reliable sources and following instructions or medical advice closely. Furthermore, government agencies and relevant authorities should strengthen market supervision to ensure consumer rights are protected.