Drug regulatory agencies in Europe and Canada have already taken action and made public announcements regarding this Picato safety issue, but the FDA is still investigating the Picato skin cancer risk.
First, earlier this year the European Medicines Agency (EMA) investigation of the Picato safety issue, i.e., whether Picato increases skin cancer risks, and the EMA’s conclusion that its Picato increased risk of skin cancer findings outweigh Picato’s benefits as a treatment of actinic keratosis.
More recently, in early July 2020, Health Canada issued an Information Update document titled “Use of the drug Picato may increase the risk of skin cancer”. From that document we get the following:
Since a potential link between the use of the medication and an increased risk of cancer has been established, Health Canada is now seeking additional information from the manufacturer to determine whether the benefits of Picato as a treatment option for actinic keratosis continue to outweigh its risks.
It seems plausible that Health Canada may reach the same conclusion as the EMA did in April 2020, which is that the skin cancer risk associated with Picato outweighs its benefits as a treatment of actinic keratosis.
Meanwhile, here in the US, it remains unknown when the FDA will update its position statement made back in January 2020, that the FDA “is gathering data and information to investigate the safety concern related to Picato”.
Of course, we will continue to monitor the FDA Picato drug safety investigation.[Read article in full at original source]