The Food and Drug Administration (FDA) is warning about reports of severe allergic reactions and herpes zoster associated with the use of Picato (ingenol mebutate topical gel). Picato is indicated for the treatment of actinic keratosis.

The FDA received reports of cases involving severe eye injuries and skin reactions associated with the application of Picato gel. Some cases were associated with Picato gel not being used according to the instructions for use on the label. As a result, FDA is requiring changes to the label to warn about these new safety risks and to provide additional instructions on the safe and appropriate application of the product. Accidental transfer of Picato gel from the hands even after washing has occurred, including through application of make-up and insertion of contact lenses. Applying Picato gel in a manner other than recommended in the product label has been associated with severe skin reactions and eye injuries.

Herpes zoster reactivation has also been reported with Picato gel use. One immunosuppressed patient experienced ophthalmic herpes zoster. Most cases reported reactivation at or near the Picato gel application site. Some reported use of the product in a manner that was inconsistent with the label such as application to areas >25cm2 and use of the 0.05% concentration of Picato gel on the scalp.

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Patients who experience a severe allergic reaction should stop using Picato gel and seek immediate medical attention. The allergic reaction may include throat tightness, difficulty breathing, feeling faint, or swelling of the lips or tongue. Patients should also stop using the product and contact their health care professionals if they develop hives, itching, or severe skin rash. If accidental eye exposure occurs, flush the eyes thoroughly with water and seek medical care.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA.

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