Photo/Illutration Kobayashi Pharmaceutical Co. President Satoshi Yamane at a financial results briefing on Aug. 8 in Osaka’s Chuo Ward (Mari Endo)

Kobayashi Pharmaceutical Co. announced that it had failed to report 11 additional cases potentially linked to its “benikoji” dietary supplements to the health ministry.

Satoshi Yamane, company president, apologized at an online news conference on Aug. 13, acknowledging that there were problems with the company’s internal system for verifying complaints from bereaved families.

He also announced plans to increase the number of personnel involved in identifying and reporting adverse reactions.

Of the 11 deaths reported by bereaved families, the company has confirmed that five cases were unrelated to the consumption of its red yeast supplements, while two cases are still under investigation.

The remaining four cases will be referred to medical professionals for further investigation.

The additional cases were discovered during a re-examination of patients’ data as the company prepares to launch a full-scale compensation program this month.

Company policy stipulates any deaths where a causal link with the supplements cannot be ruled out should be reported to the ministry. The oversight was a result of this internal policy not being fully implemented.

This latest revelation comes after Kobayashi Pharmaceutical faced criticism for taking two months to report customers' initial medical issues to the health authorities before the problem became public this spring.

Additionally, it came to light in late June that the number of suspected deaths was more than 10 times higher than previously announced.

In July, the company was also found to have failed to report all of the food and supplement manufacturers to which it supplied benikoji ingredients.

“The circumstances were slightly different in each case,” said Yamane regarding Kobayashi Pharmaceutical's repeated failures to report crucial information.

“In the case of this latest incident, the company's personnel were overwhelmed by the sudden onset of the problem and were unable to keep up,” he said.

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