"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"...
Information for Patients
- Inform patients that exposure of the skin to Qutenza (capsaicin 8% patch) may result in transient erythema and burning sensation. Instruct patients not to touch the patch and that if they accidentally touch the Qutenza (capsaicin 8% patch) 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 [see Instructions for Use].
- Inform patients that they may be given medication to treat acute pain during and after the Qutenza (capsaicin 8% patch) application procedure. Some of these medications, such as opioids, may affect the ability to perform potentially hazardous activities such as driving or operating machinery [see WARNINGS AND PRECAUTIONS].
- 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 (capsaicin 8% patch) 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 [see WARNINGS AND PRECAUTIONS].
- Instruct patients to notify their physician if they are pregnant or breast feeding [see Use In Specific Populations]
Last reviewed on RxList: 12/2/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Qutenza Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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