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EMA has started a data review of Picato (ingenol mebutate) to investigate the potential for skin cancer risk.
The European Medicines Agency (EMA) announced on Sept. 6, 2019 that it was initiating a data review of Picato (ingenol mebutate), a gel for treating actinic keratosis, a skin condition caused by too much sunlight exposure, after data from several studies showed a higher number of skin cancer cases in patients using Picato.
The agency’s Pharmacovigilance Risk Assessment Committee (PRAC) will review all available data and assess the impact of the data on the benefits versus risk of Picato. After review, PRAC will recommend any necessary amendments to the marketing authorization.
EMA is advising healthcare professionals to caution patients with a past history of skin cancer about the potential risk.