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MHRA publish advice for skin lesions with Picato▼: patient safety update

Picato ▼, for Actinic keratoses from Leo Laboratories

The Medicines and Healthcare products Regulatory Agency (MHRA) have published a warning to patients taking Leo Laboratories' actinic keratosis treatment ingenol mebutate, brand name Picato▼. The advice is that an increased incidence of skin tumours has been seen in some clinical studies.

Patients should be advised to be vigilant for new skin lesions and to seek medical advice immediately should any occur. Use with caution in patients with a history of skin cancer.

Patients taking Picato and experience any new skin lesions should consult their doctor.

You can follow developments with Picato by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

Advice to healthcare professionals
  • several clinical studies have shown an increased incidence of benign and malignant skin tumours in patients using ingenol mebutate gel 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▼ to the Yellow Card Scheme
About Picato (source EMA)
Picato is used to treat adults with actinic keratosis. Actinic keratosis is a skin lesion that develops after too much exposure to sunlight. Picato is used when the outer layer of the skin affected by actinic keratosis is not thickened or raised.

The exact way Picato works is not fully understood. It is thought that the active substance in Picato, ingenol mebutate, works in two different ways. Once applied and absorbed by the skin cells, ingenol mebutate has a direct toxic effect on the cell as well as promoting an inflammatory response. Together, these actions lead to the death of the cells affected by actinic keratosis.

Picato was first made available in the EU in 2012. It is manufactured by Leo laboratories.

European Medicines Agency website page for Picato
MHRA website
Accessed 21/10/19
Links available in External Resources

Ingenol mebutate gel (Picato▼): increased incidence of skin tumours seen in some clinical studies

New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected adverse drug reactions (ADRs) for these products. ADRs can be reported by your doctor, pharmacist or online via the Yellow Card system.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store.

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