The FDA warned that it had received 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. The lesions are typically located on areas exposed to the sun such as the face, scalp, back of the hands, and chest. The majority of these lesions are not harmful. However, actinic keratosis may occasionally develop into skin cancer. The active ingredient in Picato gel comes from a plant and works by killing the cells that make up the scaly skin patch of actinic keratosis.
The FDA has 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. As a result, the agency 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 Picato gel as prescribed by their health care professionals. Picato gel should only be applied on one skin area at a time only to skin lesions diagnosed as actinic keratosis. The application area should be no larger than approximately 2 inches by 2 inches, which is about the size of a child’s palm. 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.
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, swelling of the lips or tongue, and anaphylaxis. 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.
See the FDA Drug Safety Communication
See also Medical Law Perspectives, November 2014 Report: More Than Skin Deep: Skin Cancer Misdiagnosis and Other Liability Issues
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See the Medical Law Perspectives November 25, 2014, Blog: Skin Cancer Incidence Rises; Surgeon General Issues Call to Action
See the Medical Law Perspectives November 24, 2014, Blog: CDC Study Shows Skyrocketing Skin Cancer Costs; What Lawyers Can Learn By Examination and Persuasive Presentation of Statistics