FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

FDA Issues Safety Alert Over Leo Pharma’s Topical Keratosis

Aug. 28, 2015

The FDA is requiring additional warnings on the labeling of Leo Pharma’s Picato topical gel for actinic keratosis after receiving reports of severe allergic reactions and shingles associated with its use.

According to an FDA safety alert released last week, some of the incidents, which included eye injuries and skin reactions, resulted from the gel not being used according to instructions. To minimize future adverse events, the labeling will direct people to use Picato as prescribed and not on an area of skin larger or for longer than instructed. Patients should also avoid applying the gel in, near and around the mouth and eyes.

The new labeling will also caution patients about the risk of transferring the gel from their hands to unintended areas of the body and that this risk can occur even after washing.

The Danish drugmaker could not be reached for comment by press time.

View the safety alert at www.fdanews.com/08-24-15-PicatoGelSafetyAlert.pdf. — Kellen Owings