Other safety alerts
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| The United Kingdom: Ingenol mebutate gel (Picato): increased incidence of skin tumours seen in some clinical studies |
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The Medicines and Healthcare products Regulatory Agency (MHRA) advises patients treated with ingenol mebutate gel to be vigilant for new skin lesions and to seek medical advice immediately should any occur.
An in-depth European review into the safety of ingenol mebutate has begun following data from several studies showing an increased number of skin cancer cases in patients using ingenol mebutate gel.
A warning about the risk of keratoacanthoma was previously included in the product information. Following a separate recent review of safety data, the product information is being updated to include a warning about reports of basal cell carcinoma, Bowen’s disease, and squamous cell carcinoma, and to advise that ingenol mebutate gel should be used with caution in patients with a history of skin cancer. A letter has also been sent from the manufacturer of Picato to UK prescribers and dispensers to inform them of this risk.
Patients should be made aware of this risk and be provided with the current patient information leaflet for Picato, which already includes information about the need for patients to be vigilant for new or changing lesions. Patients should be alert for changes to the treatment area and immediately talk to their doctor if any new scaly red patches, open sores, or elevated or warty growths occur.
Healthcare professionals are advised:
- 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
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/ingenol-mebutate-gel-picato-increased-incidence-of-skin-tumours-seen-in-some-clinical-studies
Local Situation in Hong Kong: In Hong Kong, the above product is not a registered pharmaceutical product
Ends/ Saturday, 19 Oct, 2019
Issued at HKT 13:00
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