Drug Information Update - FDA Drug Safety Communication: FDA warns of severe adverse events with application of Picato (ingenol mebutate) gel for skin condition; requires label changes

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The U.S. Food and Drug Administration (FDA) is warning about reports of severe allergic reactions and herpes zoster (shingles) associated with the use of Picato gel (ingenol mebutate). Picato is used to treat actinic keratosis, a scaly, crusty lesion on the skin that may be red or yellow in color.

We have also 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, we are 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.

Patients should use Picato gel as prescribed by their health care professionals, and should not use it on an area of skin larger or for a longer period than instructed in the drug label. Also patients should avoid applying the gel in, near, and around the mouth, lips and eye area. 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 (See Additional Information for Patients section).

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.

We reviewed postmarketing cases submitted to the FDA Adverse Event Reporting System (FAERS) for Picato gel. In some cases, severe eye injuries and skin reactions occurred when the application of the product was not according to the instructions found in the labeling. Other cases described severe allergic reactions, including anaphylaxis. Herpes zoster was also reported.

We urge patients and health care professionals to report side effects or medication errors involving Picato gel to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page linked to below.

For more information, please visit: Picato gel