A Japanese pharmaceutical company is investigating 80 deaths possibly linked to a yeast-containing supplement it sells in Japan, the country’s health ministry said Friday, in a shocking increase from an earlier revelation that is focusing attention on how supplements are regulated.
The company Kobayashi Pharmaceutical had reported five deaths potentially related to its CholesteHelp rice and red yeast pills in March. Japanese government health officials said the supplement, which supposedly helps lower cholesterol, contained a highly toxic compound called puberulic acid that is a product of mold.
Responding to the sudden rise in reported deaths, Health Minister Keizo Takemi said it was “extremely regrettable” that Kobayashi Pharmaceutical had not informed the ministry earlier. The company, which is based in Osaka, had not provided new information on deaths potentially linked to CholesteHelp since March.
Since then, Kobayashi Pharmaceutical has received reports that 1,656 people sought medical advice for health problems related to CholesteHelp and 289 people have been hospitalized, the company reported. CholesteHelp has been removed from the market in Japan and China, the only countries in which the supplement was sold, according to a spokeswoman for Kobayashi Pharmaceutical.
Takemi said the government would step in to take a more active role in the investigation, after allowing the company to report its findings. “We can’t let Kobayashi Pharmaceutical deal with this alone,” he said.
Kobayashi Pharmaceutical was founded in 1919. While it is not one of Japan’s major pharmaceutical companies, it produces a variety of health supplements and products, such as hand warmers and air fresheners, some of which are sold in the United States and in other parts of Asia.
In 2015, Japan established quality control standards related to supplements and other products that make health claims. These rules are considered to be less strict than those governing prescription drugs. Companies are often responsible for self-reporting compliance, rather than submitting to state controls.
In the United States, where the dietary supplement market is booming, organizations such as the American Medical Association have urged the Food and Drug Administration to implement stricter rules to ensure the safety of supplements. Dietary supplements marketed for weight loss and muscle building have been linked to several deaths in the United States.
At a press conference in March, when deaths potentially linked to CholesteHelp were first revealed, Kobayashi Pharmaceutical President Akihiro Kobayashi apologized for not providing information sooner and said he was “at a loss for words.”
