July 26, 2016
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"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...




  • Inform patients that exposure of the skin to Qutenza may result in transient erythema and burning sensation. Instruct patients not to touch the patch and that if they accidentally touch the Qutenza patch it may burn and/or sting.
  • Instruct patients that if irritation of eyes or airways occurs, or if any of the side effects become severe, to notify their doctor immediately.
  • Inform patients that the treated area may be sensitive to heat (e.g., hot showers/bath, direct sunlight, vigorous exercise) for a few days following treatment.
  • Inform patients that they may be given medication to treat acute pain during and after the Qutenza application procedure. Some of these medications, such as opioids, may affect the ability to perform potentially hazardous activities such as driving or operating machinery.
  • Inform patients that as a result of treatment-related increases in pain, small transient increases in blood pressure may occur during and shortly after Qutenza treatment and that blood pressure will be monitored during the treatment procedure. Instruct patients to inform the physician if they have experienced any recent cardiovascular event
  • Instruct patients to notify their physician if they are pregnant or breast feeding.

Last reviewed on RxList: 2/22/2016
This monograph has been modified to include the generic and brand name in many instances.

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