Japanese authorities inspect second Kobayashi Pharma factory after deaths (updated)

Kobayashi Pharmaceutical

31/03/2024 09:12

(Adds response from South Korea's food ministry in paragraphs
15-16)
       TOKYO, March 31 (Reuters) - Health authorities searched
a second Kobayashi Pharmaceutical  4967.T  factory in western
Japan on Sunday after the company reported five deaths possibly
tied to dietary supplements, an official said.
    The inspection in Wakayama prefecture follows one on
Saturday in Osaka, expanding the investigation into the
drugmaker's use of "Beni-Koji" red yeast materials.
    Osaka-based Kobayashi said it found what appeared to be
potentially toxic puberulic acid that could have been produced
by blue mould penicillium in Beni-Koji materials produced
between last April and October at the Osaka factory.
    As of Friday, 114 people had been hospitalised and five had
died after taking the supplements, which were marketed as
helping lower cholesterol levels, the company said.
    The cause of the deaths has not been confirmed, the official
at Japan's Health and Welfare Ministry told Reuters. But "it is
suspected that Beni-Koji may be the cause, so we have inspected
two factories in two days."
    Kobayashi said on Friday it was investigating a suspected
link between the products and their effects on the kidney since
it received reports of kidney disease linked to the products.
    "We will fully cooperate with the investigation so that we
can resolve the problems as early as possible," the head of
Kobayashi's investor relations, Yuko Tomiyama, told reporters on
Sunday in footage shown by public broadcaster NHK.
    The health official said the ministry "would join hands with
other ministries concerned to do our utmost to resolve the
ongoing case while asking Kobayashi Pharma to cooperate as
needed in looking into the case".
    The factory in Osaka's Yodogawa Ward was closed in December
due to ageing facilities and production shifted to the factory
in the city of Kinokawa that was searched on Sunday, Japanese
media reported.
    The government has criticised the company for taking two
months to announce the health impacts of its products. Kobayashi
began recalling products on March 22 after receiving reports of
kidney ailments. 
    Its products are also consumed in other countries.
    Japanese media said a case of acute renal failure had been
reported in Taiwan. Taiwan's food and drug administration is
investigating three "unexpected health reactions" that may be
related to imported materials from Kobayashi, Taiwan's official
Central News Agency reported.
    A Chinese consumers association urged consumers to stop
using potentially affected products, saying it was concerned
about the risk of Kobayashi products, state media reported on
Friday.
    Japan's health ministry is aware of the Taiwanese cases, the
official said, declining to comment further on any international
cases.
    South Korea's ministry of food and drug safety has posted
the list of 182 Japanese recalled products made by Kobayashi and
other companies that contain red yeast rice, asking consumers
not to purchase those items online. 
    The South Korean ministry said on Friday that authorities
would dispose or return shipments related to the Kobayashi case
at customs. It did not respond to a request for additional
comment outside normal business hours.
    Kobayashi sells Beni-Koji wholesale to 52 companies, which
have conducted voluntary inspections and found no materials
requiring medical consultation as of Friday, NHK said. Those
companies sell the materials on to 173 others, it said.
    TV Asahi reported that some 1,800 foodmakers could be
affected.
    Beni-Koji contains Monascus purpureus, a red mould used as a
food colouring.

 (Reporting by Tetsushi Kajimoto in Tokyo; Additional reporting
by Ju-min Park in Seoul; Editing by William Mallard and Jamie
Freed)
 ((tetsushi.kajimoto@thomsonreuters.com;))