Information update - LEO Pharma Inc. is withdrawing the drug Picato (Ingenol mebutate), used to treat skin lesions, due to the potential increased risk of skin cancer

OTTAWA, ON, Oct. 27, 2020 /CNW/ -

Summary

Product: Picato (ingenol mebutate)
Issue: Using Picato may increase the risk of non-melanoma skin cancer.
What to do: Stop your treatment and talk to your healthcare professional about other treatment options. Monitor your skin for signs or symptoms of skin cancer.            

At Health Canada's request, LEO Pharma Inc. is withdrawing Picato from the Canadian market. This follows a safety review by the Department, which concluded that use of Picato may be associated with an increased risk of non-melanoma skin cancer, and that the benefits of using Picato no longer outweigh its potential risks.

Picato was approved for use on the skin (topically) in adults to treat actinic keratosis, a condition where thick, hard and scaly patches appear on skin that has been damaged by too much sun exposure.

On October 26, 2020, LEO Pharma Inc. initiated the recall of Picato from the Canadian market.

Health Canada is monitoring the effectiveness of the recall and is advising patients who are being treated with Picato to:

• stop their treatment and contact their healthcare professional to discuss other treatment options;
• monitor and immediately report to their healthcare professional any signs or symptoms of skin cancer, such as new scaly red patches on their skin, open sores, or elevated or warty growths within the treatment area, which could occur after stopping treatment; and
• contact LEO Pharma Inc. at 1-800-263-4218 or [email protected] if they would like more information about the recall or directions on how to dispose of the product.

LEO Pharma Inc. is advising healthcare professionals to:

• not prescribe or dispense Picato; and
• contact patients under their care who are currently being treated with Picato to:
• tell them to stop treatment with Picato and review alternative treatment options; and
• counsel patients to report signs or symptoms of skin cancer, such as new scaly red patches on their skin, open sores, or elevated or warty growths within the treatment area, which could occur after stopping treatment.

Health Canada has issued an additional communication for healthcare professionals.

SOURCE Health Canada

Media Inquiries: Health Canada, 613-957-2983, [email protected]; Public Inquiries: 613-957-2991, 1-866-225-0709