Severe Adverse Event Warnings Added to Picato Gel Label

Ingenol mebutate (Picato) gel’s label must now include reported risks of shingles and anaphylaxis.

Picato gel is indicated to treat actinic keratosis, a scaly lesion on the skin that may be red or yellow in color. However, the FDA received reports of herpes zoster reactivation, severe eye injuries, and skin reactions associated with the gel’s application, some of which stemmed from not applying the gel according to the recommendations in the drug’s label.

As a result, the FDA is requiring changes to Picato’s label to warn about these new risks and provide additional instruction on the product’s appropriate application.

“Patients…should not use [Picato gel] on an area of skin larger or for a longer period than instructed in the drug label [and] should avoid applying the gel in, near, and around the mouth, lips, and eye area,” the FDA warned. “Accidental transfer of Picato gel from the hands even after washing has occurred, including through application of makeup and insertion of contact lenses.”

Those who experience a severe allergic reaction, which may include throat tightness, difficulty breathing, feeling faint, or swelling of the lips or tongue, should stop using Picato and seek immediate medical attention. Patients should also stop using the product and contact their health care professionals if they develop hives, itching, or severe skin rash.

The FDA is also asking health care professionals and patients to report any adverse side effects to its MedWatch Safety Information and Adverse Event Reporting Program.