The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug safety update, urging health professionals to stop prescribing ingenol mebutate (Picato) for actinic keratosis and consider other alternatives as appropriate.
The UK watchdog has suspended the licence of ingenol mebutate gel as a precautionary measure, while the European Medicines Agency (EMA) continues to review the evidence for the increased incidence of benign and malignant skin tumours associated with the drug in several clinical studies. In January 2020, the EMA recommended suspending the marketing authorisation for ingenol mebutate gel after final results from a three-year safety study indicated a higher occurrence of skin cancer in treated patients.
Between 2013 and January 2020, 10 cases of skin malignancies associated with ingenol mebutate gel were reported in the UK in both clinical trial and post-marketing settings. These cases included cutaneous squamous cell carcinoma, atypical fibroxanthoma, neuroendocrine carcinoma of the skin, Bowen’s disease and basosquamous carcinoma.
Prescribers should advise patients to remain vigilant for new skin lesions and seek prompt medical advice if any are found. Patients should also be encouraged to report any suspected adverse drug reactions associated with products containing ingenol mebutate to the Yellow Card Scheme.
