Gel used to treat skin condition has been pulled from the market
By Caitlin Finlay
On October 26, 2020, LEO Pharma Inc. announced the recall of Picato, a topical drug used to treat skin lesions, after a review by Health Canada discovered the use of Picato may increase the risk for non-melanoma skin cancer.
Picato (Ingenol mebutate) had previously been approved for use in Canada as a treatment for actinic keratosis in adults. Also known as solar keratosis, actinic keratosis is a skin condition in which sun-damaged skin develops thick, hard, scaly patches. These patches are most commonly found on the face, ears, lips, forearms, neck, scalp, and on the back of hands. The skin patches develop over a period of years and are most common in adults over 40.
During international clinical trials, it was found that patients using Picato had an increased risk for skin cancer. Based on this new information, Canada conducted a review of studies, case reports, and medical literature and determined that the potential risk for skin cancer outweighed the benefits of taking Picato. Health Canada then requested a recall from the manufacturer, LEO Pharma Inc., and the medication was officially recalled on October 26.
Health Canada recommends that those using Picato stop treatment and discuss alternatives with their doctor. Those who have used Picato should keep an eye out for signs of skin cancer within the treatment area and contact a medical professional should any symptoms appear. Signs of cancer include elevated or warty growths, scaly red skin patches, and open sores.
Photo: istock/Ninell_Art (gel) and bankrx (stamp).