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Rationale For Triggering.pdf

flupirtine-containing-medicines-article-107i-procedure-rationale-triggering_en.pdf
Preview of Rationale for triggering
🔗 Source: ema.europa.eu
📊 Size: 97 KB
📄 Pages: 5 pages
⬇️ Downloads: 67

Summary

Germany's Federal Institute for Drugs and Medicinal Devices initiated a procedure under Article 107i of Directive 2001/83/EC due to concerns over flupirtine's safety, specifically its association with idiosyncratic liver toxicity. There have been 954 reports of adverse reactions, including 330 related to hepatic and biliary disorders, with 49 cases of liver failure and 15 fatal outcomes or liver transplants. The majority of these cases occurred after several weeks of treatment. While clinical trials have not reported liver failure, some have noted elevated transaminases in patients treated with flupirtine. The efficacy of flupirtine is mainly supported for acute pain, but there is insufficient data for chronic pain. Germany recommends a benefit-risk evaluation due to the severe liver toxicity reports.

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Description

Germany's Federal Institute for Drugs and Medicinal Devices initiated a procedure under Article 107i of Directive 2001/83/EC due to concerns over flupirtine's...

Technical Information

  • File Format: PDF
  • File Size: 97 KB
  • Pages: 5
  • Language: EN
  • Total Downloads: 67
  • Last Updated: 2 weeks ago

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