Administrative Guidance against 武田薬品工業株式会社
Action summary
- Company
- 武田薬品工業株式会社Japanese onlyOriginal: 武田薬品工業株式会社Corporate Number: 2120001077461
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices薬機法
- Action type
- Administrative Guidance行政指導
- Action date
- October 24, 2014
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
There have been reports of cases where administration of this drug caused a significant increase in blood bilirubin levels, leading to liver and kidney dysfunction, and resulting in death. Therefore, the following precautions should be observed: 1. Regularly measure blood bilirubin levels during treatment. 2. Discontinue the drug and provide appropriate treatment if abnormal persistent elevation of blood bilirubin is observed. 3. Even after discontinuation, blood bilirubin levels may remain elevated; patients should be monitored carefully. 4. Instruct patients to seek medical attention immediately if they develop jaundice of the eyes or skin, dark urine, or general fatigue after administration.
Show original Japanese text
本剤投与により血中ビリルビン値が著しく上昇し、肝機能障害、腎機能障害等を発現し、死亡に至った症例が報告されているので、次の事項に注意すること。1.本剤投与中は定期的に血中ビリルビン値を測定すること。2.血中ビリルビン値の持続的な上昇等の異常が認められた場合には本剤の投与を中止し、適切な処置を行うこと。3.本剤投与中止後も血中ビリルビン値が上昇することがあるので、患者の状態を注意深く観察すること。4.患者に対し、本剤投与後に眼球・皮膚の黄染、褐色尿、全身倦怠感等がみられた場合は、直ちに受診するよう指導すること。
Source
Original Ministry of Health, Labour and Welfare announcement (in Japanese)The original Japanese disclosure is the authoritative record.
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Language
日本語版を見る (Japanese)Company info
- English name
- 武田薬品工業株式会社 Japanese only
- Japanese name
- 武田薬品工業株式会社
- Corporate Number
- 2120001077461
- Registered address
- 大阪府大阪市中央区道修町４丁目１番１号
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.