Japanese pharmaceutical company Kobayashi Pharmaceutical is investigating 80 additional deaths potentially linked to its health supplement tablets containing red yeast rice, known as Beni Koji.
This supplement is marketed for its cholesterol-lowering properties. The investigation follows the product's recall a few months ago after numerous reports linked it to kidney problems, leading to five reported fatalities and around 100 hospitalizations.
Company Response and Denials
Kobayashi Pharmaceutical has denied that the hospitalizations or deaths were related to kidney diseases. However, the company acknowledged that there were a "variety of cases" in which Beni Koji-related products may have caused harm indirectly. The company is committed to thoroughly investigating these cases.
Understanding Beni Koji
-
What is Beni Koji?
Beni Koji, or red yeast rice, is a traditional Japanese ingredient created by fermenting rice with the reddish-purple fungus Monascus purpureus. It has been consumed for centuries in countries like China, Taiwan, and Japan for its health benefits and distinctive red color, often used to flavor and color dishes such as tofu and Chinese rice wine.
- Health Benefits
In the 1970s, researchers discovered that Beni Koji contains ‘monacolin K’, a cholesterol-lowering compound similar to statin drugs. It also contains antioxidants, amino acids, and beneficial enzymes that contribute to overall health. This discovery significantly boosted Beni Koji’s popularity in health supplements.
-
Use in Supplements
Kobayashi Pharmaceutical included Beni Koji in its supplement ‘Beni-koji Choleste-Help,’ promoting its cholesterol-lowering abilities. However, concerns arose due to the presence of citrinin, a toxic byproduct of the fermentation process linked to kidney disease. Despite these concerns, Kobayashi asserted that no citrinin had been detected in their products.
Health Concerns and Reports
-
Initial Reports
In March, a person who had been consuming Beni Koji for three years died from kidney disease. Another death was reported by the Ministry of Health, Labour, and Welfare after consulting with the company. Despite these incidents, Kobayashi stated it did not understand the link between the health issues and its products. They noted that the supplements contained “ingredients we had not intended to include.”
-
Symptoms Reported
Customers who consumed the supplements manufactured after September reported symptoms such as changes in urine color, swelling in their limbs, and fatigue. Of the five initial deaths under investigation, one was later confirmed not to have consumed red yeast rice.
-
Current Investigation
Kobayashi has received 1,656 inquiries from individuals who sought medical attention, with 76 cases currently under investigation for a potential connection to the deaths.
The Giant Recall
-
Global Recall Initiated
As safety concerns grew, Kobayashi Pharmaceutical initiated a global recall of its Beni Koji products. The company apologized to the public and recalled 300,000 units of the cholesterol-lowering supplement.
-
Impact on Distribution
Kobayashi had exported Beni Koji-based supplements to over 50 companies in Japan and two in Taiwan. In response to the health scare, Taiwanese firms recalled 154 products, including fermented salted squid, senbei rice crackers, and Japanese sake containing the ingredient. Online sales and distribution of the recalled products were also suspended in China and Taiwan.
-
European Response
In France, consumers were advised to consult a doctor before consuming Beni Koji products. In Switzerland, the sale of foods and medicines containing the ingredient was banned.
Further Developments
-
Discovery of Toxic Acid
Kobayashi later disclosed the discovery of a potentially toxic acid produced by the mold at one of its factories. This prompted Japanese health officials to conduct raids on two of the company’s plants under the Food Sanitation Act.
-
Government Response
Top government spokesman Yoshimasa Hayashi expressed regret over the company’s failure to report the specific number of cases under investigation. The health ministry had previously ordered Kobayashi to file daily reports on its investigation and demanded more details after the number of deaths under investigation remained unchanged.
The investigation is ongoing as Kobayashi Pharmaceutical continues to address the health concerns and potential impacts of its Beni Koji products.
With inputs from agencies
Image Source: Multiple agencies
© Copyright 2024. All Rights Reserved Powered by Vygr Media.
