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