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FDA Warning for Picato Gel Eye Injuries and Skin Reactions

FDA Warning for Picato Gel Eye Injuries and Skin Reactions

August 21, 2015 — Picato gel has been associated with severe skin reactions and eye injuries, according to a Safety Communication from the FDA.

Picato (ingenol) is a gel used to treat actinic keratosis, a skin condition caused by too much sun exposure that typically causes crusty growths on the face, scalp, lips, and hands.

Reports of severe allergic reactions (anaphylaxis) and reactivation of herpes zoster (shingles) have been linked to Picato gel. According to the agency:

“Avoid applying Picato gel in, near, and around the eyes, in the mouth, and on the lips. If Picato gel gets into your eyes, immediately flush them with large amounts of water and get medical care right away.”

The label already warns against getting Picato gel in the eyes, but the FDA is concerned it does not adequately emphasize the risk of application errors when putting on make-up or inserting contact lenses — even after hand-washing.

Warning signs of an allergic reaction toPicato gel:

  • Throat tightness
  • Difficulty breathing
  • Feeling faint
  • Swelling of the lips or tongue
  • Hives
  • Itching
  • Severe skin rash

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