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Common to disorders of consciousness and patients on medication
December 17, 2020 5:40 PM
Hiroyuki Kobayashi, President of Kobayashi Kako (center) and others explaining to press how the component of the sleep-inducing agent was mixed = December 12, Yachi, Awara City, Fukui Prefecture
“The person who was taking the prescribed medicine there was rushed for loss of consciousness.” On November 27, the emergency hospital contacted Dr. Kensuke Kubo (63) in Takayama city, Gifu prefecture. A 59-year-old man is said to have lost consciousness while driving a car and came out of the ditch. It was the beginning of an “incident”.
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Dr. Kubo is the director of a bed clinic that specializes in internal medicine and atopy treatment. After the emergency transport of a 59-year-old man, I noticed that the situation of the four hospitalized patients was different than usual. When I ate breakfast, I sometimes slept into the night, and when I woke up, sometimes I lost part of my memory.
As for other outpatients, a woman in her thirties fell asleep on the morning of December 2. A 32-year-old man lost consciousness in the tunnel during delivery work and collided with a pole on the center line. He doesn’t remember that time, and even after the accident, he kept working as he tried.
The seven patients with impaired consciousness had something in common. Dr. Kubo recalls: “I was convinced that everything was caused by itraconazole.”
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Clinically, the oral antifungal agent Itraconazole tablets has been used for several years to treat malacetic folliculitis, which is common in atopic dermatitis. All patients take 2 tablets once a day. Dr. Kubo says, “I used it with confidence because it had few side effects.”
He immediately called the dealer manager, reported the patient’s symptoms in writing, and offered to stop the sale. It was manufactured by Kobayashi Kako (headquarters: Awara City, Fukui Prefecture), a manufacturer of medium-sized generic drugs. Dr. Kubo’s complaint was the beginning of the discovery of numerous health hazards.
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According to Kobayashi Kako, there have been two reports of side effects from the tablet every day and one every other day since the beginning of December. However, “there are daily reports of cases of drug side effects, and we have not yet recognized them (the so-called health dangers),” recalls the executive.
On day 3, Dr. Kubo from Gifu reported the side effects of 7 people and 2 people from other prefectures, a total of 9 people, and I finally realized the seriousness of the matter.
The company said that the itraconazole 50 “MEEK” tablets shipped between September 28 and December 3 on December 4 were mixed with the sleep-inducing agent “lyl mazafone hydrochloride hydrate” and were taken by patients, including young girls. 2 years. He announced that 12 people had health problems.
When 4 tablets are taken, the amount of contamination is 10 times the maximum dose. Since the tablet is classified as “Class 1”, which can cause serious harm to health or death, we have started voluntary collection of the corresponding lot.
Reports of health hazards, such as loss of consciousness, memory loss, and dizziness, continued to rise thereafter. The number of patients prescribed reached 364 in 31 prefectures.
On the 10th, a woman in her 70s died in a hospital in the metropolitan area. President Hiroyuki Kobayashi bowed on the 12th and said, “I made a serious mistake and I am well aware of my responsibility. I want to make it up to the entire company.”
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The drug made by Kobayashi Kako was mixed with a component that induces sleep, causing a number of health risks across the country. Why did the wrong mix occur that should not occur? I followed the process and verified it. ⇒ Second verification series in edition D
[Tabletas de itraconazol]An antifungal agent that is used to treat nail worms and yeast infections, and it is a generic drug (generic drug). Kobayashi Kako has been manufacturing and selling since July 2004. There are three items, itraconazole tablets 50, 100, and 200, depending on the amount of active ingredient. The pharmaceutical company “Meiji Seika Pharma” sold approximately 100,000 tablets in the same 50 batches that contained the component of the sleep-inducing agent.
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