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August 21, 2015: FDA Orders Label Change to Picato Gel

According to a Drug Safety Communication published by the FDA, the agency has received multiple reports regarding the keratosis treatment gel Picato. These reports included the contraction of shingles and severe allergic reactions associated with use of Picato gel. Throat tightness, difficulty breathing, feeling faint, or swelling of the lips or tongue may be symptoms of an allergic reaction to Picato gel. Additional reports described severe eye injuries and skin reactions, some of which were caused by improper application.

Picato Gel Found to Cause Dangerous Reactions and Injury

In an effort to prevent these injuries, Picato Gel must now include new instructions and warnings on the packaging of this product. This new labeling will detail clearly the instructions to avoid adverse injury and reactions.

The FDA listed some measures specifically that will be included on the new packaging. The following addresses directives regarding possible injury:

“Patients should use Picato gel as prescribed by their health care 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 Picato gel from the hands even after washing has occurred, including through application of make-up and insertion of contact lenses. If accidental eye exposure occurs, flush the eyes thoroughly with water and seek medical care. Applying Picato gel in a manner other than recommended in the product label has been associated with severe skin reactions and eye injuries.”

Regarding possible allergic reactions, the FDA provides these instructions:

“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..”

See the FDA Safety Communication for more details on Picato Gel and new safety information.

More Information On Picato Gel

Picato Gel is a treatment to actinic keratosis. Actinic keratosis a scaly, crusty, red or yellow lesion on the skin. Skin that is often exposed to the sun such as the chest, back of the hands, scalp, and face. This condition is not harmful typically, but could possibly develop into skin cancer in some cases. Picato gel is derived from a plant that fights actinic keratosis by killing the cells that make up the skin lesion.

About 70,000 patients received a prescription for Picato (ingenol mebutate) gel in 2014 in the United States.

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