MHRA/CHM ADVICE (UPDATED FEBRUARY 2020): INGENOL
MEBUTATE GEL (PICATO ®): SUSPENSION OF THE LICENCE DUE TO
RISK OF SKIN MALIGNANCY
Clinical studies have shown an increased incidence of
benign and malignant skin tumours (such as basal and
squamous cell carcinoma, Bowen’s disease, and
keratoacanthoma) in patients using ingenol mebutate
gel; cases of neuroendocrine carcinoma of the skin, and
atypical fibroxanthoma have also been reported.
Healthcare professionals are advised to stop prescribing
ingenol mebutate gel and consider alternative treatment
options for actinic keratosis. The licence of ingenol
mebutate has been suspended as a precautionary
measure while investigations are carried out. Healthcare
professionals should advise patients to be vigilant for the
development of any new skin lesions within the
treatment area and to seek immediate medical advice if
any occur.
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▶Common or very common Headache
▶Frequency not known Neoplasms. skin eruption localised
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Not absorbed from skin, but manufacturer
advises avoid.
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Not absorbed from skin; ensure infant
does not come in contact with treated area for 6 hours
after application.
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