Information Update - Use of the drug Picato may increase the risk of skin cancer

Starting date:
July 2, 2020
Posting date:
July 2, 2020
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals
Identification number:
RA-73461

Last updated:

July 2, 2020
For immediate release

Summary

Product: Picato (ingenol mebutate)
Issue: Use of the drug Picato may increase the risk of skin cancer.
What to do: 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.

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 Inquiries:

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

Public Inquiries:

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