Other safety alerts
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| Canada: Summary Safety Review: Picato (ingenol mebutate): Assessing the Potential Risk of Skin Cancer |
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Health Canada announces that it reviewed the potential risk of skin cancer with the use of Picato. The review was triggered by new safety information from international clinical trials that found an increased risk of skin cancer in patients treated with Picato.
Health Canada reviewed the available information from searches of the Canada Vigilance database, evidence given by the manufacturer, and studies published in scientific and medical literature. Health Canada's review focused on 43 international clinical trials and found that there was enough evidence to link the use of Picato with skin cancer. Health Canada reviewed 29 case reports (including one Canadian case ) of skin cancer in patients treated with Picato. Of the 29 cases, 26 cases were found to be possibly linked. In the other 3 cases (including the Canadian case), a link was found to be unlikely because of the presence of the skin cancer inside and outside of the area treated with the drug. Assessing whether the skin cancer was related to the use of Picato was challenging in all 29 cases due to several factors including a medical history of skin cancer or use of other medications known to increase the risk of skin cancer. Health Canada assessed 12 studies published in scientific and medical literature in order to determine the link between the use of Picato and skin cancer. Health Canada's review found that 6 of the 12 studies had evidence of skin cancer with the use of Picato.
Health Canada's review found that there may be a link between Picato and the risk of skin cancer. Health Canada will ask for additional information from the manufacturer to determine whether the benefits of the use of Picato continue to outweigh its risks as a treatment option for actinic keratosis.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00242
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by the United Kingdom Medicines and Healthcare products Regulatory Agency and European Medicines Agency, and was posted on the Drug Office website since 19 Oct 2019, with the latest update posted on 2 May 2020.
Ends/Friday, Jul 3, 2020
Issued at HKT 15:00
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