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FUKUI -- Investigations following the death of a woman who took skin medication tainted with a sleep-inducing substance mistakenly added at a central Japan drug firm have found that an employee at the firm recorded the addition of the soporific during the manufacturing process.
The finding, revealed through Mainichi Shimbun inquiries to the Fukui Prefectural Government and the health ministry on Dec. 15, give rise to suspicions that the company neglected to conduct checks after the error by the employee, who was unfamiliar with the procedure.
The death of a woman in her 70s and other health problems have been reported among individuals prescribed with the contaminated antifungal medication, which was manufactured by Kobayashi Kako Co., based in Fukui Prefecture, on the Sea of Japan.
The Fukui Prefectural Government is considering taking disciplinary action against the firm by issuing a business suspension order, on the grounds that it neglected safety inspections.
The sleep-inducing substance rilmazafone hydrochloride hydrate was found in "Itraconazole tablet 50 'MEEK'" antifungal medication, which was manufactured in June and July 2020, and shipped to the market from September to December of the same year.
Substances were apparently sometimes added to drugs because they occasionally decrease in quantity during the manufacturing process. According to the firm, an employee mistakenly mixed rilmazafone hydrochloride hydrate into the medication during this addition process. Figures indicating this soporific had been included remained in work records.
The additional mixture of substances is not permitted for the medication under the manufacturing process established by the Ministry of Health, Labor and Welfare, due to the possibility of these substances becoming spread unevenly through the tablets.
Meanwhile, it has been revealed that the drug maker may have overlooked data that pointed to the mixture of foreign substances, which was recorded when a sample inspection using a method known as "liquid chromatography" was conducted in July to examine the components of the drug prior to its shipment.
Health problems were reported to the firm in December, and the possibility that a sleep-inducing substance had been mixed into the pill surfaced after the drug maker reinvestigated the data. The blunder came to light following an examination of records made during the manufacturing process.
Japan's pharmaceuticals and medical devices law requires drug manufacturers to create and record the manufacturing process of medicines, and to ship pharmaceuticals only after inspecting their quality based on the records. Although Kobayashi Kako Co.'s internal regulations specify that the retrieval and measurement of ingredients be carried out in pairs while making confirmations by pointing at items, the employee responsible for the procedure had been working alone. It is suspected that the safety of products had not been checked in various parts of the manufacturing process, including the work records that noted the mixture of sleep-inducing drugs, and the results of the sample inspection analysis.
A health ministry representative said, "Had the company checked the records properly, it's hard to think that it would have shipped the pills out as they were."
(Japanese original by Koichi Kirino, Osaka City News Department, and Riki Iwama, Fukui Bureau)
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