July 2, 2020

Health Canada Drug Advisory: Picato may increase skin cancer

Health Canada has found that there may be a link between the drug Picato and an increased risk of skin cancer. Health Canada undertook a safety review to examine this potential link after learning of new safety information from international clinical trials. The Department's review included information from clinical trials, Canadian and international case reports, scientific and medical literature and what is known about the use of this drug both in Canada and internationally.

Picato (ingenol mebutate) is a topical prescription drug used to treat adults with actinic keratosis, which causes thick, hard and scaly patches on skin damaged as a result of too much sun exposure. It is available in two strengths: 0.015% and 0.05%.

Since a potential link between the use of the medication and an increased risk of cancer has been established, Health Canada is now seeking additional information from the manufacturer to determine whether the benefits of Picato as a treatment option for actinic keratosis continue to outweigh its risks.

The Department will continue to monitor safety information involving Picato to identify and assess potential risks, as it does for all health products on the Canadian market and will take appropriate and timely action if new health risks are identified.