Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 April 2020

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 April 2020 | European Medicines Agency

EMA's safety committee (PRAC) has confirmed that Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, may increase the risk of skin cancer and concluded that the risks of the medicine 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The marketing authorisation for Picato was withdrawn in February 2020.

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