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Actinic Keratosis Treatment Suspended by EMA

By: Kayci Reyer
Posted: Tuesday, February 4, 2020

According to a press release from the European Medicines Agency (EMA), patients using the actinic keratosis treatment gel ingenol mebutate (Picato) are being advised to stop treatment. This cautionary statement is due to an ongoing safety review being performed by the Pharmacovigilance Risk Assessment Committee of the EMA.

The review was initiated following results from a 3-year, comparative study on ingenol mebutate and imiquimod. Of 484 patients, those using ingenol mebutate experienced an increased occurrence of skin cancer in the area undergoing treatment (3.3%) than did patients using imiquimod (0.4%). Another trial found that patients using ingenol mebutate experienced a higher incidence of skin tumors (1%) than did the vehicle arm (0.1%) of an 8-week, 1,262-patient trial. These findings led to concern about a potential link between ingenol mebutate gel and the development of skin cancer. Four additional trials totaling 1,234 patients overall observed an increased occurrence of skin tumors in patients treated with ingenol disoxate (7.7%), an ester related to ingenol mebutate, compared with those treated with a vehicle control (2.9%).

Because of these concerns, the safety committee has recommended that the marketing authorization for ingenol mebutate be suspended pending investigation results. The safety committee has also recommended that patients discontinue use of ingenol mebutate and remain vigilant about any unusual changes in skin condition. They advise patients who do observe abnormalities of the skin to promptly seek medical advice. In addition, they suggest that health-care professionals cease prescribing the treatment and opt instead for alternative treatments.



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