Japanese officials enter a Kobayashi Pharmaceutical factory to conduct an on-site inspection in Osaka City, on 30 March, 2024.
Japanese health officials searched a Kobayashi Pharmaceutical factory on Saturday after the drugmaker reported five deaths possibly linked to dietary supplements using red yeast rice, an official said.
The Ministry of Health, Labour and Welfare and the City of Osaka jointly inspected the factory in Osaka that had made the supplements containing "Beni-Koji" red yeast, suspected of having caused health damage, the ministry official said.
News footage showed officials entering the factory, and the official said the ministry could search other related locations.
The factory, which made the product until December, had been closed due to ageing facilities, Japanese media said.
The Osaka-based company could not immediately be reached for comment. Yuko Tomiyama, head of Kobayashi's investor relations, told public broadcaster NHK the firm intends to sincerely deal with the matter and fully cooperate with the investigation.
Kobayashi said on Friday it was investigating a suspected link between the products and their effects on the kidney since it received reports of kidney disease linked to the products.
As of Thursday evening, 114 people had been hospitalised and five had died after taking the supplements, which were marketed as helping lower cholesterol levels, according to the company.
Kobayashi said it is examining the earnings impact of the latest issues.
Japanese Chief Cabinet Secretary Yoshimasa Hayashi criticised the company on Tuesday for its slow response, saying it was regrettable that Kobayashi took two months to announce the health impacts of its products.
The company has been recalling products with Beni-Koji in recent days after receiving reports of kidney ailments. Its products are also consumed in places such as China, and Japanese media said a case of acute renal failure had been reported in Taiwan.
A Chinese consumers association urged consumers to stop using affected products, saying it was concerned about the risk of Kobayashi products, state media reported on Friday.
Beni-Koji contains Monascus purpureus, a red mould that is also used as a red colouring in some foods.
Puberulic acid - a potent antibacterial and antimalarial agent that can be produced from blue mould and can be toxic - was confirmed in a batch of the products that caused health complaints, Japanese media said.
- This story was first published by Reuters
Xinhua
2024-03-30
Japan's health ministry and local authorities on Saturday inspected the Osaka factory of Kobayashi Pharmaceutical following reports of deaths and hospitalizations possibly linked to its dietary supplements containing red yeast rice, known as "beni-koji."
The factory in western Japan, which was making the ingredients of the product named Beni-koji Choleste Help, a type of granules advertised with the effect of lowering LDL cholesterol levels, shut down in December.
However, the Ministry of Health, Labour and Welfare and the Osaka city government decided to carry out an on-site inspection in light of the widening health problems regarding the Osaka-based drugmaker's beni-koji products.
Kobayashi Pharmaceutical on Friday announced one additional death suspected to be linked to the consumption of beni-koji supplements, bringing the death toll to five.
While more than 110 people have been hospitalized over health damage and nearly 700 have either seen a doctor due to health issues or wish to do so, the company, during a press conference held in Osaka on Friday, revealed plans to compensate approximately 800 individuals who reported health issues after consuming the product.
An unintended component called "puberulic acid" has been detected in the company's product, according to Japan's health ministry.
The findings, disclosed by the Osaka-based company during an expert panel meeting convened by the health ministry on Thursday, stated that puberulic acid, derived from blue mold, was identified in a batch of the supplements linked to health issues.
The substance is a potent antibacterial and antimalarial agent that can be toxic, but the extent to which its ingestion may pose health risks or cause kidney damage remains unclear, according to the ministry.
The company rolled out Choleste Help in February 2021, selling around 1 million packages by the end of February this year.
Since last week the health scare over Kobayashi Pharmaceutical's beni-koji supplements has been growing after the company announced that 13 people who took the products suffered health damage including kidney disease.
According to local media reports, it took the pharmaceutical over two months to disclose the damage they had been aware of, and the Consumer Affairs Agency announced plans to conduct an emergency inspection of over 6,000 functional foods.
The voluntary recall of products containing Kobayashi Pharmaceutical's beni-koji as a food ingredient has now expanded nationwide, affecting various products including sake, confectionery, bread and miso.
Earlier reports showed that the company had supplied the rice fermented with red yeast to 52 manufacturers.
Kobayashi Pharmaceutical Friday confirmed that its beni-koji red yeast rice supplements have claimed a fifth life. The company said 114 people who used the supplements have been hospitalized and 680 have had or are seeking outpatient treatment.
March 29 (UPI) -- Kobayashi Pharmaceutical on Friday announced a fifth death related to its beni-koji supplements.
The company said puberulic acid from blue mold was found in the red yeast rice products, a compound that was not expected to be in the supplements.
The family of a person who died from suspected kidney failure had been taking the company's red yeast malted rice supplement, but the Japanese pharma company said it doesn't know how long the person had been using it.
The five people beni-koji users who have died so far have been in their 70s to 90s, according to Kobayashi.
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The company said 114 people who used the supplement have been hospitalized while another 680 people have or are seeking outpatient treatment for their symptoms.
Kobayashi said it will offer compensation to all of them.
"Determining a cause and preventing (the incident) from occurring again is our responsibility. I will make sure as the company's head to get that done," Kobayashi Pharmaceutical President Akihiro Kobayashi said at a press conference.
About 300,000 packages of the company's "beni-koji choleste help" supplement marketed to lower cholesterol were recalled and Japan is sharing information about the health impacts with the World Health Organization.
Japan's government and the company are continuing to investigate the substance found in the products and how it may have gotten into them.
At the Osaka press conference Friday Kobayashi said it didn't go public with the problem until March 22 even though they first noticed a potential problem in January because they had problem identifying the cause of the health problems linked to the supplements.
Kobayashi Pharmaceutical Thursday reported two more deaths linked to its beni-koji red yeast rice supplements. More than 100 people have been hospitalized. The company has recalled the products.
March 28 (UPI) -- Two more deaths were reported Thursday linked to Kobayashi Pharmaceutical's beni-koji supplement ingredients, according to the company. A total of four deaths have been reported so far.
More than 100 other people have been hospitalized with kidney problems after taking the supplements with the rice fermented with red yeast ingredient.
Kyodo News, citing a public relations officials, said that company president Akihiro Kobayash told an Osaka shareholder's meeting, "We will make a companywide, all-out effort to prevent the spread of further damage and investigate the cause" of the deaths and hospitalizations.
Japan is also sharing information about the health impacts of the supplement with the World Health Organization.
Wednesday Japan's health ministry notified the city of Osaka, where Kobayashi Pharmaceutical is based, to destroy the beni-koji products and the city issued the order to the company.
The company said it was notified of the first death Tuesday.
Roughly 300,000 packages of the company's "beni-koji choleste help" supplement marketed to lower cholesterol were recalled.
According to Japan's health ministry most of the reports of people suffering health problems from the beni-koji supplements are linked to those manufactured since September last year.
A wide range of Kobayashi Pharmaceutical products containing beni-koji are affected and the company has asked that all companies with supplies of the product voluntarily recall them.
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