ingenol mebutate gel - increased incidence of skin tumours seen in some clinical studies

Last edited 02/2022 and last reviewed 02/2022

An MHRA alert has suggested (1):

Advice for health professionals

• several clinical studies have shown an increased incidence of benign and malignant skin tumours in patients using ingenol mebutate gel (Picato) when compared to those using a vehicle only or an alternative treatment
  UK reports of skin cancers during use of ingenol mebutate gel

• in the past year, approximately 32,450 packs of ingenol mebutate gel were dispensed in the UK
• since 2013 and up to August 2019, reports of 9 cases of skin malignancies in the UK associated with ingenol mebutate, including cutaneous squamous cell carcinoma (including 1 metastatic case), atypical fibroxanthoma, neuroendocrine carcinoma of the skin, Bowen's disease, and basosquamous carcinoma. These reports were received in both clinical trial and post-marketing settings

NOTE: As of February 2020, the licence of ingenol mebutate (Picato) has been suspended as a precautionary measure while the European Medicines Agency (EMA) continues to investigate concerns about a possible increased risk of skin malignancy (2)

Reference:

• (1) MHRA.Ingenol mebutate gel - increased incidence of skin tumours seen in some clinical studies.Drug Safety Update volume 13, issue 3: October 2019: 1
• (2) MHRA. Drug Safety Update (February 2020). Ingenol mebutate gel (Picato): suspension of the licence due to risk of skin malignancy (Accessed 27/01/2022)