Ingenol mebutate

Potential risk of skin cancer

Europe. The EMA has announced that PRAC has started a review of data on skin cancer in patients using ingenol mebutate (Picato®).

Ingenol mebutate is indicated to treat actinic keratosis, a skin condition caused by overexposure to sunlight.

The PRAC will review all available data (including ongoing studies), assess the impact of the data on the benefit-harm balance of ingenol mebutate use and recommend whether the medicine’s marketing authorisation in the EU should be amended.

Health-care professionals should use ingenol mebutate with caution in patients that have had skin cancer in the past. Patients should continue to watch for any skin lesions and inform their health-care professionals immediately if they notice anything unusual.

Reference: EMA, 6 September 2019