The European Medicines Agency (EMA) has initiated a safety review of ingenol mebutate (Picato).
The review has been initiated at the request of the European Commission (EC) after data from several studies showed a higher number of skin cancer cases, including cases of squamous cell carcinoma, in patients using Picato.
The product information for Picato already contains a warning about reports of keratoacanthoma. Following a previous review, this warning is currently being updated to mention basal cell carcinoma, Bowen’s disease and squamous cell carcinoma.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will now carry out a thorough review of all available evidence, including data from ongoing studies. The review will assess the impact of the data on the benefit-risk balance of Picato and will recommend whether the medicine’s marketing authorisation in the European Union (EU) should be amended.
The PRAC recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), which will adopt an opinion. This opinion will then be forwarded to the EC for adoption of a legally binding decision applicable in all EU Member States.
In the meantime, healthcare professionals are advised to use Picato with caution in patients who have had skin cancer in the past.