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

Starting date:
July 2, 2020
Posting date:
October 27, 2020
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals
Identification number:
RA-74195

Last updated:

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.

Update: October 27, 2020

OTTAWA – 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 medical-info.ca@leo-pharma.com 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.

History

July 2, 2020: Information Update - Use of the drug Picato may increase the risk of skin cancer

 

OTTAWA - 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.

What consumers should do

  • Do not stop taking this medication without talking to your health care provider.
  • Talk to your health care provider if you have concerns about taking this medication.
  • Look for any new scaly red patches, open sores, elevated or warty growths where the medication is applied. If you find any, talk to your health care provider.
  • To reduce your risk of skin cancer, follow safety tips, such as covering up and limiting your time in the sun.
  • Report any health product adverse events or complaints to Health Canada.
  • Contact the company directly if you have questions about this medication:
    1-800-668-7234 or visit LEO Pharma.

What health care professionals should do

  • Consider the risk of serious adverse events before prescribing Picato.
  • As indicated in the product monograph, tell patients taking Picato to watch for the development of skin lesions where the medication is applied and to seek medical assistance if they occur. Lesions that are not clearly associated with actinic keratosis, or that may be cancerous, should be examined by a health care provider to determine the appropriate treatment.

Media enquiries

Health Canada
613-957-2983
hc.media.sc@canada.ca

Public enquiries

613-957-2991
1-866-225-0709