FDA Warns of Severe Adverse Events With Ingenol Mebutate, Requires Label Changes

The US Food and Drug Administration (FDA) is warning about reports of severe allergic reactions and herpes zoster associated with the use of ingenol mebutate (Picato gel).

The FDA received reports of cases involving severe eye injuries and skin reactions associated with the application of ingenol mebutate. Some cases were associated with ingenol mebutate not being used according to the instructions for use on the label. As a result, the 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.

Patients should use ingenol mebutate as prescribed by their healthcare 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 ingenol mebutate from the hands even after washing has occurred, including through application of make-up and insertion of contact lenses. Applying ingenol mebutate in a manner other than recommended in the product label has been associated with severe skin reactions and eye injuries.

The allergic reaction may include throat tightness, difficulty breathing, feeling faint, or swelling of the lips or tongue.

Patients who experience a severe allergic reaction should stop using ingenol mebutate 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 healthcare 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.