The marketing authorisation of Picato (ingenol mebutate) is suspended as a precautionary measure due to growing concerns on the possible risk of skin malignancy, while EMA continues to investigate. Final results from a study comparing Picato to another medicine for actinic keratosis (Imiquimod) indicate a higher occurrence of skin cancer in the treatment area with Picato. Healthcare professionals should stop prescribing Picato and consider other treatment options as appropriate. Healthcare professionals should advise patients to be vigilant for any skin lesions developing and to seek medical advice promptly should any occur. Class 2 Pharmacy/Wholesale Level Recall: LEO Pharma is recalling all unexpired stock of the products from pharmacies and wholesalers. The recall is a precautionary measure while investigations are ongoing.
For Healthcare Professionals