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Sleep-inducing agent for drugs, killed 134 people
December 13, 2020 7:10 am
Kobayashi Kako President Hiroyuki Kobayashi (second from left) and others apologize for the problem that the sleep-inducing agent component got mixed into the manufactured drug = around noon on December 12, Yachi, Awara City , Fukui prefecture
Kobayashi Kako (Headquarters: Awara City, Fukui Prefecture) changed the oral antifungal agent Itraconazole Tablets 50 “MEEK”, which is voluntarily collected with a sleep-inducing agent component, in the final quality test to confirm the components contained in the December 12th. “I couldn’t do a tight check,” he said. Furthermore, the mixing was caused by the wrong raw materials in a process that had not been approved by the Ministry of Health, Labor and Welfare. The patient who died after taking the tablet was a woman in her 70s who was admitted to a hospital in the metropolitan area. Investigate the causal relationship with the intake.
On this day, executives such as President Hiroyuki Kobayashi explained at the company in response to an interview with the press. President Kobayashi apologized: “I have made a serious mistake and I am well aware of my responsibility,” in response to the myriad of health hazards and deaths.
Regarding the tablets containing the component of the sleep-inducing agent, President Kobayashi said, “If you look at the confirmation by the quality test, you may have (noticed the contamination). We could not do a strict control.” .. In the future, an outside organization familiar with the quality of pharmaceuticals will be involved in investigating the cause and working to prevent recurrence.
Initially, when the company reviewed the tablet’s quality test record, it detected the ingredient reaction that was originally not found, but explained that it was “generally not noticeable.”
According to the company, in the tablet manufacturing process, by adding raw materials that are reduced due to adherence to machines, the main component and the component of the sleep-inducing agent “lil mazaphone hydrochloride hydrate” were mixed by error. The mixed amount per tablet is 2.5 times the maximum dose normally used for sleep-inducing agents.
The replenishment of raw materials is a process not included in the manual of manufacturing procedures approved by the Ministry of Health, Labor and Social Welfare, and company executives said that “the management could not understand the real situation at the site” and will investigate through a third party.
Itraconazole tablets are medicines used to treat nail worms and yeast infections. The company has been manufacturing and selling since July 2004.
According to the company, a total of 134 patients who took the contaminated tablets reported health problems such as loss of consciousness, memory loss and dizziness at midnight on the 12th. There were 15 accidents while driving a car and 33 people were transported or hospitalized. Overlap was found and accidents and hospitalizations were reduced by 1 compared to the previous day.
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