LEO Pharma has recalled all unexpired stock of Picato (ingenol mebutate) on precautionary grounds, after concerns have arisen on the possible risk of skin malignancy.
The company says that the recall is purely precautionary after the suspension of the marketing authorisation for the drug, while investigations are ongoing.
Healthcare professionals are being urged to stop supplying the treatment immediately, and to quarantine all remaining stock and return it to the supplier using the supplier’s approved process.
Last September The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) announced a review of data on skin cancer in patients using the LEO Pharma drug.
Picato, which is a gel for treating actinic keratosis – caused by too much sunlight exposure – works by removing the sun damaged cells in the skin, and also activates your body’s defences, meaning that it continues to work for several weeks after the treatment has been completed.
