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  • Hyperalgesia possibility if Fentanyl mucosa not control pain
  • by Lee, Tak-Sun | translator Choi HeeYoung | Dec 3, 2019 05:54am
MFDS submitted comments on Changes "Consider discontinuation"
Fentora Buccal Tab, Abstral sublingual tab included, added additional text on indication.
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Fentanyl mucosal drug, a typical narcotic analgesic used for the treatment of cancer patients, may not be controlled by hyperalgesia and resistance, will be reflected in the permit.

This was done by the Agency by reviewing safety information from the European Medicines Agency (EMA).

The permission change adds that fentanyl mucosal medications may cause hyperalgesia if pain is not controlled, and that dose reduction and discontinuation may be considered.

In particular, new content is added to the usage and dosage located in the upper line of the permit. The additional phrase is, "If pain is not properly controlled, there is a possibility of hyperalgesia, tolerance and underlying disease progression, which shou
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