Photo/Illutration Health ministry officials enter the Osaka plant of Kobayashi Pharmaceutical Co. on March 30. (Kenta Sujino)

Japanese health officials searched a Kobayashi Pharmaceutical Co. plant in Osaka following reports of five deaths linked to its cholesterol-lowering supplements using red yeast.

The factory was manufacturing the suspected culprit benikoji ingredient until late last year. The company first announced its suspicions on March 22.

At least 114 people have been admitted to hospitals complaining of kidney problems after consuming the supplements, which are available over the counter and taken orally.

The March 30 search marked the first time the central government has mounted an investigation at any facility of Osaka-based Kobayashi Pharmaceutical in connection with the benikoji supplement health scare now gripping Japan.

According to company officials, the plant in Osaka’s Yodogawa Ward began operating in 1940 and had been manufacturing the benikoji ingredient used in the company’s supplements.

However, it closed in December and the workers and equipment there are now in the process of being moved to facilities outside Osaka Prefecture.

But the officials from the health ministry and Osaka city government are hoping to examine any equipment remaining at the Osaka plant to help them determine the cause of the deaths.

Kobayashi Pharmaceutical also has a plant in Wakayama Prefecture where the benikoji ingredient is manufactured, and health ministry officials were scheduled to start an investigation there on March 31.

On March 29, the health ministry and Kobayashi Pharmaceutical separately announced that highly toxic puberulic acid may be behind the health problems.

Health ministry officials will check the manufacturing process to determine how puberulic acid might have been mixed into the benikoji ingredient.

Puberulic acid is a natural compound made from blue mold and has antibiotic properties, making it effective in fighting malaria.

But so far there are no studies that directly link puberulic acid to kidney problems, which has been the main issue from ingesting the supplements.

On March 30, 16 officials spent around five hours looking over the equipment and scrutinizing written records to determine hygiene management at the Osaka plant.

The Osaka city government on March 27 issued a formal order to Kobayashi Pharmaceutical to recall three supplements that contain the benikoji ingredient. The Osaka city government is expected to issue another order to destroy those supplements once the recall has been confirmed.

But the recall process could take months to complete.

After days of staying silent on the health crisis, the centralgovernment is now moving to get more involved, officials said.

Kobayashi Pharmaceutical said it has no idea how puberulic acid could have become mixed into the benikoji ingredient.

Further complicating matters, there are mycotoxins that have been linked to kidney problems. One is citrinin, which can be created by the benikoji mold. Another is ochratoxin A, which is created by a different mold.

But puberulic acid is not known as a mycotoxin.

Naoaki Ono, an associate professor of bioinformatics at Nara Institute of Science and Technology, conducted a DNA analysis on benikoji mold in a joint research project with Kobayashi Pharmaceutical.

He concluded there was a very low probability that the benikoji mold created the puberulic acid.

He suggested that another mold or microorganism could have entered the manufacturing process for the benikoji ingredient.

The National Institute of Health Sciences will play the central role in determining how puberulic acid entered the picture.

Kobayashi Pharmaceutical has kept three years’ worth of ingredient samples, all of which will be checked.

Officials noted that other elements might have got mixed into the ingredient, triggering the health problems. The toxicity of puberulic acid and its effect on human health is now an issue that is being researched as a matter of urgency.

(This article was compiled from reports by Tatsuya Harada, Kazuya Goto, Doni Tani, Natsumi Adachi, Kenta Noguchi, Tomoyuki Suzuki and Mirei Jinguji.)

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