▼Picato® (ingenol mebutate) – Suspension of the marketing authorisation due to risk of skin malignancy

For Healthcare Professionals

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.