January 2020 News Report: FDA "is gathering data and information to investigate the safety concern related to Picato"
UPDATE: The UK's Medicines and Health products Regulatory Agency (MHRA) issued a class 2 medicines recall for Picato on January 27, 2020.
This regulatory action comes after the earlier voluntary sales suspension of Picato by LEO Pharma.
The topical gel drug Picato (ingenol mebutate) is prescribed for the treatment of actinic keratosis, or solar keratosis, a skin condition that can become cancerous in some patients. However, the safety of Picato is currently under scrutiny, as the European Medicines Agency (EMA) is investigating whether the use of Picato increases skin cancer risks.
From this January 17, 2020 press release, "EMA suspends Picato as a precaution while review of skin cancer risk continues", we get this information about the safety of Picato:
EMA is recommending that patients stop using Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine’s safety.
EMA’s safety committee [Pharmacovigilance Risk Assessment Committee (PRAC)] is currently reviewing data on skin cancer in patients using Picato. Final results from a study comparing Picato with imiquimod (another medicine for actinic keratosis) indicate a higher occurrence of skin cancer in the treatment area with Picato than with imiquimod.
While uncertainties remain, there is concern about a possible link between the use of Picato and the development of skin cancer. The PRAC has therefore recommended suspending the medicine’s marketing authorisation as a precaution and noted that alternative treatments are available.
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The company that markets Picato, LEO Pharma, issued a January 7, 2020 statement which sets forth its position on this new Picato drug safety issue:
The voluntary withdrawal [of Picato] is not linked to any new incidents of adverse events, customer complaints or quality effects....
LEO Pharma has carefully reviewed the information received from PRAC, and the company disagrees with the ongoing assessment of PRAC. There is no additional safety data and it is LEO Pharma’s position that there is no evidence of a causal relationship or plausible mechanism hypothesis between the use of Picato® and the development of skin malignancies.
A Medscape news report, "European Marketing of Picato Suspended While Skin Cancer Risk Reviewed", published January 17, 2020 let us know about the status of Picato in the US as that point in time:
"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. We remain in dialogue with the U.S. Food and Drug Administration about Picato in the EU/EEA," Rhonda Sciarra, associate director of global external communications for LEO Pharma, said in an email. "We remain committed to ensuring patient safety, rigorous pharmacovigilance monitoring, and transparency," she added.
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 continue to monitor the safety of Picato and report any further drug regulatory actions here.
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