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Use of ingenol mebutate may increase risk of skin cancer

Photo credit Future FamDoc

According to Health Canada, there may be a link between the medication ingenol mebutate, a topical treatment for actinic keratosis, and an increased risk of skin cancer. In a press release (July 2, 2020), the health agency said it is currently seeking further information from the manufacturer to determine whether the benefits of ingenol mebutate outweigh the risks. Health Canada began a safety review of ingenol mebutate to examine its potential link to skin cancer after learning new safety information from international clinical trials. The agency’s review included information from clinical trials, Canadian and international case reports, scientific and medical literature, and information on what is known about the use of this treatment both in Canada and internationally. “The Department will continue to monitor safety information involving [ingenol mebutate] 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,” the agency said in the press release. Health Canada recommends doctors consider the risk of serious adverse events before prescribing ingenol mebutate. Additionally, doctors should tell patients using ingenol mebutate 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 associated with actinic keratosis, or that may be cancerous, should be examined by a health care professional to determine the appropriate treatment.

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