Ingenol mebutate withdrawn

Ingenol mebutate, sold under the brand name Picato, is a popular and effective treatment for solar keratoses, a potentially pre-cancerous form of solar damage. It has been withdrawn from sale following a review by the European Medicines Agency (EMA), which showed that people treated with Picato were more likely to develop skin cancers. The review compared outcomes in people treated for solar keratoses with Picato vs. imiquimod.

After three years, 6.3 per cent of patients treated with Picato developed skin cancer in the treated area, compared with 2 per cent of patients treated with imiquimod. Most of the skin cancers were squamous cell carcinoma.

Patients treated with Picato were three times more likely to develop skin cancers in the treated area.

Picato is no longer available in Australia since late 2020. Spot Check Clinic has not prescribed Picato since becoming aware of the EMA review in 2019.

Patients treated with Picato should be alert for unusual skin changes or growths in the treated area.

Ingenol mebutate was an appealing treatment because of its relatively short course. It could be completed in 3-4 days rather than the 4-week course required by other solar keratosis treatments such as fluorouracil and imiquimod.

Fortunately, a new treatment option is available for people wanting a short course of effective treatment for solar keratoses: combination treatment with fluorouracil and calcipotriol is effective, has been shown to reduce skin cancer risk, and requires only 4-6 days of treatment for solar keratoses.

References

European Medicines Agency, 2020. Risks of Picato for actinic keratosis outweigh benefits.