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 these new concerns about the safety of Picato:
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.
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:
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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