The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has announced a review of data on skin cancer in patients using Picato (ingenol mebutate), a gel for treating actinic keratosis, which is a skin condition caused by too much sunlight exposure.
The organisation explained the review was triggered by data from several studies showing a higher number of skin cancer cases, including cases of squamous cell carcinoma in patients using the drug.
In order to conclude on whether Picato increases the risk of skin cancer, the committee will now carry out a thorough review of all available data, including from ongoing studies. It will also assess the impact of the data on the benefit-risk balance of Picato and recommend whether the medicine’s marketing authorisation in the EU should be amended.
The organisation also stated that healthcare professionals are advised to use Picato with caution in patients who have had skin cancer in the past. In addition, patients should continue to watch out for any skin lesions and inform their doctor immediately if they notice anything unusual.
The drug is a gel for the treatment of actinic keratosis, which is rough areas of skin caused by over-exposure to sunshine during a person’s life. It works by removing the sun damaged cells in the skin, and also activates your body’s defences, meaning that it continues to work for several weeks after the treatment has been completed.