FDA Investigation Of This Picato Drug Safety Issue Seems To Be Still Ongoing, Despite Picato Recall In Europe
A European drug safety panel announced in April 2020 that Picato increased risk of skin cancer findings outweigh Picato's benefits as a treatment of actinic keratosis. On January 27, 2020 we posted this article, "Picato Skin Cancer Risk Investigation By European Drug Regulator Prompts Sales Suspension In Europe", which provides some background for this Picato drug safety issue.
As regards this new development, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) noted a higher occurrence of skin cancers in areas treated with Picato (ingenol mebutate) than in areas of skin treated with another actinic keratosis treatment, imiquimod. It also noted that Picato’s benefit is not maintained over time and that other treatment options are available.
The Picato increased risk of skin cancer findings were further explained in this April 17, 2020 European Medicines Agency press release, "EMA review of Picato concludes medicine’s risks outweigh its benefits":
The conclusions are based on a review of all available data on the risk of skin cancer in patients using Picato, including results of a study comparing Picato with imiquimod (another medicine for actinic keratosis). The study showed a higher occurrence of skin cancers, especially squamous cell carcinoma, in areas of skin treated with Picato than in areas treated with imiquimod.
The [PRAC] also considered that Picato’s effectiveness is not maintained over time and noted that other treatment options are available for actinic keratosis....
Patients who have been treated with Picato should look out for unusual skin changes or growths, which may occur from weeks to months after use, and seek medical advice if any occur. Patients who have questions or concerns about their treatment should consult their doctor or pharmacist. [emphasis added]
Strictly Confidential, No Obligation.
As mentioned in our January 2020 article about this Picato skin cancer risk, at that point in time the FDA was gathering data and information to investigate this Picato drug safety issue. Therein we referenced a Medscape news report, "European Marketing of Picato Suspended While Skin Cancer Risk Reviewed", published January 17, 2020:
"This matter does not affect Picato in the U.S., and there are no new developments in the [United States]. Picato continues to be available to patients in the U.S...." Rhonda Sciarra, associate director of global external communications for LEO Pharma, said in an email.
The FDA "is gathering data and information to investigate the safety concern related to Picato," a spokesperson for the FDA told Dermatology News. "We are committed to sharing relevant findings when we have sufficient understanding of the situation and of what actions should be taken," he added.
We will monitor the FDA Picato skin cancer risk investigation and report any significant drug regulatory actions on our Drug Injury Watch site.
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)