Other safety alerts
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| Canada: PICATO (ingenol mebutate gel, 0.015% and 0.05%): Product withdrawal in Canada due to potential increased risk of skin cancer |
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Health Canada announces that it conducted a safety review of PICATO (ingenol mebutate) 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.
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 2 Jul 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 14 Oct 2020, Health Canada directed LEO Pharma Inc. to stop the sale of PICATO at the manufacturer level. Subsequently, on 26 Oct 2020, LEO Pharma Inc. initiated the recall of PICATO from the Canadian market.
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.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../74193a-eng.php
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 19 Oct 2019, with the latest update posted on 3 Jul 2020.
Ends/Wednesday, Oct 28, 2020
Issued at HKT 15:00
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