Japanese supplement-related deaths suddenly rise to 80

A Japanese pharmaceutical company is investigating 80 deaths that may be linked to a yeast-containing supplement it sells in Japan, the country’s health ministry said Friday, in a shocking escalation from an earlier revelation that is focusing attention on how supplements are adjusted.

The company, Kobayashi Pharmaceutical, in March had reported five deaths potentially linked to its CholesteHelp rice and red yeast pills. Japanese government health officials said the supplement, which claimed to help lower cholesterol, contained puberulic acid, a highly toxic compound that is a product of mold.

In response to the sudden increase in reported deaths, Health Minister Keizo Takemi said it was “extremely unfortunate” that Kobayashi Pharmaceutical had not updated the ministry sooner. The company, which is based in Osaka, had not released any new information on deaths possibly linked to CholesteHelp since March.

Since then, Kobayashi Pharmaceutical has received reports that 1,656 people sought medical advice for health concerns related to CholesteHelp, and 289 people were hospitalized, the company said. CholesteHelp has been recalled in Japan and China, the only countries where the supplement was sold, according to a spokeswoman for Kobayashi Pharmaceutical.

Mr. Takemi said the government would step in to take a more active role in the investigation after allowing the company to self-report its findings. “We can no longer leave Kobayashi Pharmaceutical alone to handle it,” he said.

Kobayashi Pharmaceutical was founded in 1919. While not one of Japan’s top pharmaceutical companies, it produces a variety of supplements and health products such as hand warmers and air fresheners, some of which are sold in the United States and elsewhere in Asia. .

Quality control guidelines regarding supplements and other products making health claims were established in Japan in 2015. These rules are perceived to be less stringent than Japan’s rules governing prescription drugs. Companies are usually responsible for self-reporting compliance rather than being subject to state controls.

In the United States, where the market for dietary supplements is booming, organizations such as the American Medical Association have asked the Food and Drug Administration to introduce stricter regulations to ensure the safety of supplements. Dietary supplements marketed for weight loss and muscle building have been linked to a number of deaths in the United States.

At a press conference in March when the possible deaths linked to CholesteHelp were first revealed, Kobayashi Pharmaceutical president Akihiro Kobayashi apologized for not providing information earlier and said he was “at a loss for words.”