EMA is recommending that patients stop using Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine’s safety.

EMA’s safety committee (PRAC) is currently reviewing data on skin cancer in patients using Picato. Final results from a study comparing Picato with imiquimod (another medicine for actinic keratosis) indicate a higher occurrence of skin cancer in the treatment area with Picato than with imiquimod.

While uncertainties remain, there is concern about a possible link between the use of Picato and the development of skin cancer. The PRAC has therefore recommended suspending the medicine’s marketing authorisation as a precaution and noted that alternative treatments are available.

The PRAC will continue its review and when the review has concluded, EMA will provide updated guidance to patients and healthcare professionals.

Posted on the EMA website on 17 January 2020