August 21, 2015 — The FDA has issued a Safety Communication to warn about reports of severe allergic reactions (anaphylaxis) and herpes zoster (shingles) associated with Picato gel.
Picato gel (ingenol mebutate) is used to treat actinic keratosis — scaly, crusty growths (lesions) caused by sun damage, usually on sun-exposed areas of the face, scalp, lips, and hands.
The FDA has received reports of severe eye injuries and skin reactions associated with Picato gel. The label will be updated to provide additional instructions on how to use Picato gel safely and appropriately.
The FDA is particularly concerned about patients accidentally getting Picato gel in their eyes when applying make-up or inserting contact lenses, for example. The agency warns:
“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.”
Herpes zoster (shingles) reactivation unrelated to application errors have also been reported in patients on Picato gel. Anaphylaxis is a sudden, severe allergic reaction that could cause suffocation if it occurs in the mouth or throat.
Signs of an allergic reaction to Picato gel:
- Throat tightness
- Difficulty breathing
- Feeling faint
- Swelling of the lips or tongue
- Severe skin rash
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