Personal Injury Law

A Global Phase-out of Picato Sales by LEO Pharma Inc. Due to this Picato Safety Finding Expected by End of 2020

(Posted by Tom Lamb at DrugInjuryWatch.com)

On October 27, 2020 Health Canada announced a Picato recall due to a the Picato safety finding "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". As seen below, however, the Picato skin cancer risk is not new, with other drug regulators issuing reports about this Picato safety finding and taking action earlier in time.

But first, more information about this latest Picato recall:

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 July 2, 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 October 14, 2020, Health Canada directed LEO Pharma Inc. to stop the sale of PICATO at the manufacturer level. Subsequently, on October 26, 2020, LEO Pharma Inc. initiated the recall of PICATO from the Canadian market.

Here is the July 2020 Picato safety alert issued by Health Canada previously: "Summary Safety Review - Picato (ingenol mebutate) - Assessing the Potential Risk of Skin Cancer".

Before this Picato recall in Canada, there had been several earlier Picato product withdrawals due to an increased risk of skin cancer as a Picato side effect.

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.

We will continue to monitor significant developments as regards the Picato safety finding of an increased risk of skin cancer as well as watch for ramifications of the 2020 global Picato recall.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)