Actinic Keratosis Gel Poses Risks for Serious Allergic Reactions and Herpes Zoster — Physician’s First Watch

Medical News |
August 24, 2015

Actinic Keratosis Gel Poses Risks for Serious Allergic Reactions and Herpes Zoster

By Kristin J. Kelley

Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH

Ingenol mebutate (Picato), used to treat actinic keratosis, will undergo a label change to highlight risks for severe allergic reactions and herpes zoster when the gel is not applied correctly, the FDA announced late last week.

The update, which follows reports of eye injuries and serious skin reactions (e.g., anaphylaxis, rashes, shingles), will include more detailed instructions on how to correctly use the gel. The label will include the following:

  • Ingenol mebutate shouldn't be used near the eyes, lips, or mouth.

  • The gel should be used to treat one area of skin at a time, and the treated area should be less than 25 square centimeters.

  • A new tube should be used for each treatment day.

  • Hands should be washed thoroughly with soap and water right after use to avoid accidental transfer of the medication.

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