Yakuji Nippo

Carried out On-site Investigation of Kobayashi Kako ‐ Health Problems Expanded to 128 Cases

With permission from Yakuji Nippo, Limited, CM Plus Corporation translated into English.
The original article is authored in Japanese, and the Japanese shall prevail in meaning in terms of content and interpretation.

【Fukui Prefecture】
Carried out On-site Investigation of Kobayashi Kako ‐ Health Problems Expanded to 128 Cases

December 14th, 2020

On December 9, 2020, the Fukui Prefectural government carried out an on-site investigation at Kobayashi Kako over the issue of contamination of oral antifungal drug "itraconazole" it manufactures and markets with a sleep inducer, for possible violation of the Pharmaceuticals and Medical Devices Act. The inspection was carried out after the company and Meiji Seika Pharma, which jointly sells the products, completed identification of the patients who were prescribed the medicine and necessary communication including discontinuation of use of the drug. As of 17:00, December 10, 128 cases of health problems including serious ones had been reported and the number is thought to be the highest number of reports of pharmaceutical-related health problems caused by improper manufacturing control. Depending on the results of the investigation, the company may be subject to administrative penalties.

The drug was contaminated with 5 mg of rilmazafone hydrochloride hydrate, a sleep-inducing ingredient, per tablet. If the drug has taken 4 times a day, the dosage would be 20 mg; this means that the drug was contaminated with the ingredient as much as 10 to 20 times the usual daily dosage.

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