Personal Injury Law

Picato Skin Cancer Risk Has Been Confirmed By European Drug Regulator; The FDA Is Still Investigating This Picato Safety Issue

(Posted by Tom Lamb at DrugInjuryWatch.com)

The topical gel drug Picato (ingenol mebutate), which is prescribed for the treatment of actinic keratosis, or solar keratosis, has been under the scrutiny of drug regulators around the world since the start of 2020.  While the FDA is still investigating the Picato skin cancer risk, drug regulatory agencies in Europe and Canada have already taken action and made public announcements regarding this Picato safety issue.

As regards what has transpired to date in Europe, we refer you to these two earlier Drug Injury Watch articles:

• "Picato Skin Cancer Risk Investigation By European Drug Regulator Prompts Sales Suspension In Europe" (January 27, 2020)
• "Picato Skin Cancer Risk Findings Are Confirmed By European Drug Safety Panel In April 2020" (April 21, 2020)

In summary, those articles discuss 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.

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More recently, on July 2, 2020, the drug regulator 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:

Health Canada has found that there may be a link between the drug Picato and an increased risk of skin cancer. Health Canada undertook a safety review to examine this potential link after learning of new safety information from international clinical trials. The Department's review included information from clinical trials, Canadian and international case reports, scientific and medical literature and what is known about the use of this drug both in Canada and internationally....

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 Picato skin cancer risk outweighs Picato's benefits as a treatment of actinic keratosis.

In the US, it remains unknown when the FDA will update its position statement made in January 2020, that the FDA "is gathering data and information to investigate the safety concern related to Picato".

We will continue to monitor the FDA Picato skin cancer risk investigation and report any significant drug regulatory actions on our Drug Injury Watch site.

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