FDA warns of severe adverse reactions with Picato gel, requires label change

The FDA has issued a safety alert regarding reports of severe allergic reactions and herpes zoster associated with the use of Picato gel.

Picato gel (ingenol mebutate, LEO Pharma) is used to treat actinic keratosis. Throat tightness, difficulty breathing, feeling faint or swelling of the lips or tongue were allergic reactions reported by the FDA in a MedWatch safety alert.

The FDA has received reports of severe eye injuries and skin reactions associated with the application of the gel, according to the alert. Some of the cases were associated with the gel not being used according to label instructions. The FDA is requiring label changes “to warn about these new safety risks and to provide additional instructions on the safe and appropriate application of the product,” according to the alert.

The FDA is advising patients to use Picato gel as prescribed by health care professional, and not use it on an area of skin larger or for a longer period than instructed by the label, according to the alert.

Avoidance of applying gel in, near or around the mouth, lips and eye area is encouraged by the FDA. The agency reports that accidental transfer of the gel even after hand washing has occurred, including via make-up application and contact lenses handling.

The FDA has warned patients to stop using Picato gel and seek immediate medical attention if they experience a severe allergic reaction, including throat tightness, difficulty breathing, feeling faint or swelling of the lips or tongue. Patients who develop hives, itching or severe skin rash should also stop using the gel.

The FDA has asked health care professionals and patients to report adverse events or side effects related to the use of Picato gel to the agency’s MedWatch Safety Information and Adverse Event Reporting program at www.fda.gov/MedWatch/report.

Reference: www.fda.gov