[ad_1]
[Mix Online]Bread waste list
[Mix Online]Item details
Kobayashi Kako The patient who died after taking Itraconazole Tablets 50 “MEEK” is a woman in her 70s living in Kanto.
Release date and time 2020/12/12 19:00
Kobayashi Kako revealed on December 12 that a patient who died after taking Itraconazole Tablets 50 “MEEK” (batch number: T0EG08) mixed with sleeping pills was a 70-year-old woman living in the Kanto region. did. The company says that “we will urgently proceed with a detailed investigation, including the causal link between this product and death.”The total number of health hazards (midnight on the 12th) increased by one from the day before to 134. Of these, 15 were driving accidents, such as automobiles, and 33 were emergency transportation / hospitalized patients (including people discharged), both one less than the previous day’s report. The company explained that the reason for the decrease in the number of reports was that “duplicates were found.”◎ Discovered by pharmacy side effect report Chills, dizziness, disturbances of consciousness, etc.This health hazard was triggered by multiple reports from pharmacies in Gifu, Osaka, and Saga to the company after December 1 that itraconazole patients had side effects such as lightheadedness, dizziness, and impaired consciousness. It has become. In response to this, Kobayashi Kako confirmed the production record and discovered that the antifungal agent was contaminated with a sleep inducer and began voluntary recovery (class I) from December 4.Class I collection target is Itraconazole Tablets 50 “MEEK” (Production Lot: “T0EG08”, 100 tablets packed in 929 boxes, shipping period is September 28 to December 3), based sleeping pill of benzodiazepines, lil mazafone hydrochloride 5 mg of hydrated salt were mixed in each tablet. The usual dose of mixed hydrated lirmazafone hydrochloride is 2 mg, which is 2.5 times the usual treatment. Since the usual dose of itraconazole is 400 mg (8 tablets per 50 mg), the daily intake can be several tens of times higher than the usual dose when taken normally. However, the estimated lethal amount of the drug is 0.05 to 0.5 g / kg, which is not the lethal amount.In the process of identifying the cause, one person did the extra work that two people had to do in the procedure manual and the drug was added to prevent the dose from dropping below the dose in the itraconazole production process. It was also found that the manufacturing process was not included in the approval certificate. Since December 7, all non-Class I lots have been voluntarily collected (Class II).◎ Reports of health hazards are increasing dailyKobayashi Kako, the manufacturer and distributor, and Meiji Seika Pharma, the distributor, have provided information to patients taking the drug through the medical institution to which they are delivered, and by day 11, 364 have been identified and contacted patients.On the other hand, reports of health hazards are increasing by the day. The Fukui Prefectural Department of Health and Welfare, which saw serious damage to health, conducted an on-site inspection of Kobayashi Kako on December 9. At the same time as requesting a report on the manufacturing process of the product, the company plans to carefully consider the possibility of violating the Pharmaceutical Products and Medical Devices Act because it contains ingredients other than those approved.
◎ Posted “Status of health damage caused by shooting” on Kobayashi Kako websiteKobayashi Kako posted “Itraconazole Tablets 50” MEEK “(batch number: T0EG08) on the company’s website at 16:30 on the 12th.” At the same time that the number of health hazard reports that have been reported so far was released, it was clarified that the number of new reports will be updated at 16:00 in principle. The main symptoms of damage to health that have been observed so far are drowsiness, lightheadedness, inclined sleep, disorder of consciousness, falling, loss of consciousness, dizziness, memory disorder, poor illness, malaise and decreased level of consciousness . ..
To print CSS
| Copyright Mix Co., Ltd. |
Copying (printing) of Mix Online pages is prohibited with the exception of copyright law.Whenever copied, the publisher’s copyright management organization (phone 03-3513-6969, FAX 03-3513-6979, email: [email protected]) Get permission. Also, please contact us, as there may be various copyrights for translations in Mix Online. |
[Mix Online]Content Notes
[Mix Online]Related files
Related files
There are no related files.
Added button
[Mix Online]Keywords banner
[Mix Online]Article evaluation
Print logo
