There have been several Picato recall announcements around the world during the past year. All of these are due to Picato skin cancer risk findings by drug safety regulators.
As reported in this October 28, 2020 item, “Denmark’s LEO Pharma initiates Picato phase-out”, published on thepharmaletter.com site:
Following safety warnings on Picato (ingenol mebutate) from regulators, including the European Medicines Agency and the US Food and Drug Administration, Danish drugmaker LEO Pharma yesterday announced it was initiating a phase-out for the product, a gel for the treatment of actinic keratosis, which is expected to be completed by year-end 2020 at the latest as follows:
In the USA, LEO Pharma provided the FDA with notification of the permanent discontinuation in the manufacture of Picato and the withdrawal of New Drug Application (NDA) 202833 as Picato will no longer be marketed.
In Australia, LEO Pharma has already informed wholesalers and prescribers about discontinuation of Picato and will be withdrawing the marketing authorization.
And, in late October 2020, Health Canada announced a Picato recall due to the Picato skin cancer risk finding findings. Specifically Health Canada found “that there may be a link between PICATO and an increased risk of non-melanoma skin cancer”, as explained in this document: “PICATO (ingenol mebutate gel, 0.015% and 0.05%) – Product Withdrawal in Canada due to Potential Increased Risk of Skin Cancer”.
We will continue to monitor significant developments as regards the Picato skin cancer risk findings as well as watch for ramifications of the 2020 global Picato recall.
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