Leo's decision to recall Picato is a precautionary measure following the temporary suspension of the product's marketing authorisation while an in-depth European safety review of ingenol mebutate gel, initiated in September 2019, is ongoing.
The potential for Picato to induce skin malignancy was considered at the time of its initial marketing authorisation, based on the purported mechanism of action and findings from an animal study. Since that time several studies have found a higher incidence of skin tumours in patients using ingenol mebutate, hence the further investigation into these concerns.
Further informationView ingenol mebutate drug recordActinic keratosis treatmentsMHRA Drug Safety Alert
The final results of a 3-year safety study showed an increased incidence of squamous cell carcinoma with ingenol mebutate versus imiquimod cream. Other studies have shown an increased incidence of skin tumours in patients treated with ingenol mebutate gel compared with those treated with vehicle gel.
Cessation of prescribing advised
The MHRA has advised clinicians to stop prescribing ingenol mebutate gel and to consider other treatment options as appropriate. Patients who have recently been prescribed the drug should be asked to be vigilant for changes to the treatment area and to immediately seek medical advice if any occur.
Pharmacists should stop supplying the drug immediately, quarantine all remaining stock and return it to their suppliers.