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French.pdf

jardiance-h-a20-1442-c-2677-0023-epar-scientific-conclusion-article-20_fr.pdf
Preview of French
🔗 Source: ema.europa.eu
📊 Size: 41 KB
👤 Author: CHMP
⬇️ Downloads: 113

Summary

Sodium-glucose co-transporter 2 (SGLT2) inhibitors, used to treat type 2 diabetes, may increase the risk of lower limb amputations. The European Medicines Agency (EMA) was informed of a 2-fold increase in amputations in patients taking canagliflozin compared to placebo. Although the exact mechanism is unknown, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) considered it a possible class effect, as all SGLT2 inhibitors share the same mechanism of action. The PRAC recommended updating product information to include the risk of lower limb amputations and advised patients to practice routine preventative foot care. Additional pharmacovigilance activities were also recommended to further investigate the risk. The benefit-risk balance of SGLT2 inhibitors remains positive, but changes to product information and additional monitoring are warranted.

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Description

Sodium-glucose co-transporter 2 (SGLT2) inhibitors, used to treat type 2 diabetes, may increase the risk of lower limb amputations.

Technical Information

  • File Format: PDF
  • File Size: 41 KB
  • Pages: 4
  • Language: EN
  • Author: CHMP
  • Total Downloads: 113
  • Last Updated: 1 month ago

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