Picato Gel Side Effects Linked To Shingles, Severe Allergic Reactions: FDA Warns

Federal health regulators have received reports of severe eye injuries and skin reactions linked to the side effects of Picato, a gel used to treat actinic keratosis. 

The FDA issued a drug safety communication on August 21, warning about the risk of severe adverse events linked to Picato gel, which is a prescription medication used to treat crusty, scaly lesions on the skin.

According to the agency, it has received reports of severe allergic reactions and shingles (herpes zoster) associated with Picato use.

The FDA is changing the Picato warning label to instruct users about the new safety risks and to provide additional instructions on its use. The agency indicates that a number of the reports suggest that consumers were not using it according to the instructions on the label.

Patients are instructed not to use Picato on an area of skin larger or for a longer period of time than indicated by the instructions on the drug label. The FDA is also warning them not to apply the gel in, near, or around the mouth, lips or eyes.

The allergic reactions on Picato may include throat tightness, breathing problems, feeling faint, or swelling of the lips or tongue. The FDA indicates that they should stop using Picato and contact their health care professional if they develop severe skin rashes, hives, or itching. They should flush eyes thoroughly with water and seek medical care if accidental eye exposure occurs.

Picato (ingenol mebutate) is distributed by LEO Pharma, Inc. It was approved in 2012 by the FDA for the topical treatment of actinic keratosis. It works by inducing cell death in affected areas. According to the FDA an estimated 70,000 patients filled Picato prescriptions in 2014.

The most common mistaken applications, according to the FDA, are wrong application sites and sizes, using the wrong strength, applying less or more than the recommended two to three days of treatment, mixing it with other topical treatments, putting bandages, dressings or overlay over the treatment area, applying make-up to the treatment area, and applying it less than two hours before going to bed.

In addition, the FDA indicates that all of the cases describe it as not having been kept refrigerated. The FDA is advising doctors to better educate patients on the drug gel’s use, including the need for refrigeration.