April 17, 2020: “EMA’s safety committee (PRAC) has confirmed that Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, may increase the risk of skin cancer and concluded that the risks of the medicine outweigh its benefits.
The conclusions are based on a review of all available data on the risk of skin cancer in patients using Picato, including results of a study comparing Picato with imiquimod (another medicine for actinic keratosis).
The study showed a higher occurrence of skin cancers, especially squamous cell carcinoma, in areas of skin treated with Picato than in areas treated with imiquimod. The Committee also considered that Picato’s effectiveness is not maintained over time and noted that other treatment options are available for actinic keratosis. Picato is no longer authorised in the EU.
In January 2020, Picato was suspended as a precaution while the review was underway. On 11 February 2020, the marketing authorisation was withdrawn at the request of LEO Laboratories Ltd, the company that marketed the medicine. Patients who have been treated with Picato should look out for unusual skin changes or growths, which may occur from weeks to months after use, and seek medical advice if any occur. Patients who have questions or concerns about their treatment should consult their doctor or pharmacist.“