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2264 pages added, reviewed or updated during the last month (last updated: 21/4/2021)


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

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An MRHA 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

  • advise patients using ingenol mebutate gel to be vigilant for the development of any new skin lesions within the treatment area and to seek medical advice immediately should any occur

  • use with caution in patients with a history of skin cancer

  • report any suspected adverse drug reactions associated with Picato

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

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:

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

Last edited 02/2020

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