FDA Warns of Severe Adverse Events with Application of Picato (ingenol mebutate) Gel; Requires Label Changes

The FDA released a Drug Safety Communication to warn about reports of severe allergic reactions and herpes zoster (shingles) associated with the use of Picato gel (ingenol mebutate), which is approved to treat actinic keratosis.

The FDA said it 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. As a result, the FDA 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.

The full alert can be found at http://www.fda.gov/Drugs/DrugSafety/ucm459142.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery