FDA warns of severe adverse events with Picato gel for skin condition

The US Food and Drug Administration has issued a warning about reports of severe allergic reactions and herpes zoster (shingles) associated with the use of Picato gel (ingenol mebutate), which is used to treat actinic keratosis, a scaly, crusty lesion on the skin that may be red or yellow in color.

Picato is a drug from independent Danish drugmaker LEO Pharma and received approval from the FDA in 2012 and in Europe in November of that year (The Pharma Letter January 29, 2012).

The FDA says it 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 for use on the label.