FDA: Ingenol mebutate gel can cause severe eye injuries

The U.S. FDA is warning that a drug used to treat the skin condition actinic keratosis has caused severe allergic reactions, including herpes zoster. 

The FDA says some cases were likely due to patients failing to follow the instructions on the label for Picato gel (ingenol mebutate, LEO Pharma, Inc, Parsippany, NJ). 

As a result, the FDA will require 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. The FDA cautions that patients should avoid applying the gel in, near, and around the mouth, lips and eye area. 

According to the FDA, accidental transfer of Picato gel from the hands has occurred even after washing, including through application of make-up and insertion of contact lenses. 

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. 

To report an adverse event or side effect:

• Complete the online MedWatch Voluntary Reporting Form.

• Download the form or call 800-332-1088 to request the reporting form. Complete and return it to the address on the form, or fax to 800-FDA-0178.