PICATO (ingenol mebutate gel, 0.015% and 0.05%) - Product Withdrawal in Canada due to Potential Increased Risk of Skin Cancer

Starting date:
October 27, 2020
Posting date:
October 27, 2020
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Product withdrawal, Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-74193

Last updated:

Audiences

Healthcare professionals who manage skin conditions including, but not limited to, dermatologists, primary care physicians with an interest in skin diseases, and pharmacists.

Key messages

  • Following Health Canada’s safety review which concluded that there may be a link between PICATO and an increased risk of non-melanoma skin cancer, the manufacturer, LEO Pharma Inc., is withdrawing PICATO from the Canadian market at Health Canada’s request. PICATO was approved in Canada for the topical treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults.
  • On October 26, 2020, LEO Pharma Inc. initiated the recall of PICATO from the Canadian market to the retail pharmacy level.
  • Healthcare professionals are advised to:
    • not prescribe or dispense PICATO
    • contact patients under their care who are currently being treated with PICATO to stop treatment, and review alternative treatment options
    • counsel patients who have been treated with PICATO to contact a healthcare professional if they experience 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

   

Issue

Health Canada conducted a safety review of PICATO and concluded that there may be a link between its use and an increased risk of skin cancer. In light of the unfavourable benefit-risk profile, the manufacturer is withdrawing PICATO from the Canadian market at Health Canada’s request.

Products affected

Manufacturer Product Generic Name Drug Identification Number (DIN)
LEO Pharma Inc. Picato® 0.015% gel

Ingenol mebutate

2400987
LEO Pharma Inc. Picato® 0.05% gel Ingenol mebutate 2400995

Background information

PICATO (ingenol mebutate) was approved in Canada for the topical treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults.

Health Canada conducted a safety review of PICATO and concluded that there may be a link between its use and an increased risk of non-melanoma skin cancer. On July 2, 2020, Health Canada informed Canadians of this risk. In light of the risk of cancer, Health Canada further assessed the benefit-risk profile of PICATO and determined that the benefits of treatment with PICATO do not outweigh the potential risk of skin cancer.

On October 14, 2020, Health Canada directed LEO Pharma Inc. to stop the sale of PICATO at the manufacturer level. Subsequently, on October 26, 2020, LEO Pharma Inc. initiated the recall of PICATO from the Canadian market.

Contact LEO Pharma Inc. at 1-800-263-4218 or medical-info.ca@leo-pharma.com for more information regarding the recall of PICATO.

Who is affected

Information for consumers

PICATO (also known as ingenol mebutate) is a prescription drug 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. It is available in two strengths: 0.015% and 0.05%.

PICATO will no longer be available on the Canadian market as Health Canada has concluded that use of PICATO may be associated with an increased risk of non-melanoma skin cancer, and the benefits of using PICATO no longer outweigh its potential risks.

Patients who are currently being treated with PICATO should stop treatment and contact their doctor to discuss other treatment options.

Patients should report to their healthcare professional 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.

Information for healthcare professionals

Health Canada concluded that there may be a link between the use of PICATO and an increased risk of non-melanoma skin cancer, and that the benefit-risk profile of PICATO is negative. At Health Canada’s request, LEO Pharma Inc. is withdrawing PICATO from the Canadian market. PICATO will also be removed from pharmacies across Canada.

Healthcare professionals are advised to:

  • not prescribe or dispense PICATO
  • contact patients under their care who are currently being treated with PICATO to stop treatment, and review alternative treatment options
  • counsel patients who have been treated with PICATO to contact a healthcare professional if they experience 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.

Action taken by Health Canada

Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site . This communication will be further distributed through the MedEffect™ e-Notice email notification system as well as through social media channels including LinkedIn and Twitter.

Report health or safety concerns

Health Canada’s ability to monitor the safety of marketed health products depends on healthcare professionals and consumers reporting adverse reactions and medical device incidents. Any case of skin cancer or other serious or unexpected side effects in patients using PICATO should be reported to LEO Pharma Inc. or Health Canada.

LEO Pharma Inc.
123 Commerce Valley Drive East, Suite 400
Thornhill, ON L3T 7W8
Toll free: 1-800-263-4218
E-mail: medical-info.ca@leo-pharma.com

To correct your mailing address or fax number, contact LEO Pharma Inc.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:

Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Original signed by

Alice Kowalczyk
Senior Medical Manager
Medical Affairs
LEO Pharma Inc.