The European Medicines Agency's safety committee (PRAC) has confirmed that LEO's Laboratories' Picato (ingenol mebutate), used to treat the skin condition actinic keratosis, may increase the risk of skin cancer.
Following a safety review of all available data, the agency concluded that the risks of the medicine outweigh its benefits.
The review included results of a study comparing Picato with imiquimod, another medicine for actinic keratosis, which showed a higher occurrence of skin cancers, especially squamous cell carcinoma, in areas of skin treated with LEO's drug.
Picato is no longer authorised in the EU – as LEO requested that its marketing authorisation be withdrawn in February – but the EMA is advising patients who have been treated with the drug seek medical advice if they discover unusual skin changes or growths, which may occur from weeks to months after use.
