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A Japanese pharmaceutical company is investigating 80 deaths possibly linked to yeast-containing supplements it sold in Japan, the health ministry said Friday, a number that is alarmingly higher than earlier reports and raises concerns about the way supplements are regulated.
Kobayashi Pharmaceutical Co. reported five deaths in March that may have been linked to its CholesteHelp rice and red yeast rice pills. Japanese government health officials said the supplement, which is said to help lower cholesterol, contained a highly toxic compound called Puberulic acid, a product of mold.
In response to the sudden surge in reported deaths, Health Minister Keizo Takemi said it was “extremely regrettable” that Kobayashi Pharmaceutical did not inform the ministry sooner. The Osaka-based company has not provided new information on deaths that may be linked to CholesteHelp since March.
Since then, Kobayashi has received reports that 1,656 people have sought medical advice for health problems related to CholesteHelp, including 289 hospitalizations. A Kobayashi spokesman said CholesteHelp has been recalled in Japan and China, the only countries where the supplement is sold.
Mr. Takemi said the government would step in and take more aggressive action after allowing the company to report its own findings. “We can no longer let Kobayashi handle this on its own,” he said.
Kobayashi Pharmaceutical was founded in 1919. While it is 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 other parts of Asia.
In 2015, Japan established quality control guidelines for supplements and other products that claim to have health benefits. The rules are considered less stringent than Japan’s regulations governing prescription drugs. Companies are generally responsible for self-reporting compliance rather than being subject to state scrutiny.
In the United States, dietary supplements Booming marketthe American Medical Association and other groups have urged the Food and Drug Administration to implement stricter regulations to ensure the safety of supplements. Dietary Supplements For weight loss and muscle building Linked to multiple deaths In the U.S.
At a news conference in March when the deaths possibly linked to CholesteHelp were first revealed, Kobayashi Pharmaceutical President Akihiro Kobayashi apologized for not providing the information sooner and said he had “nothing to say.”
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