Class 2 drug alert (action within 48 hours): Leo Laboritories’ Picato 150mcg/g and 500mcg/g gel (ingenol mebutate)

Leo is recalling all stock of Picato Gel (ingenol mebutate) from pharmacies and wholesalers as a precautionary measure due to concerns of possible risk of skin malignancy. The recall follows the suspension of the marketing authorisation for Picato while investigations are ongoing

SPS commentary:

The European Medicines Agency (EMA) had previously issued a statement recommending that patients stop using Picato (ingenol mebutate) while it continues its review of the medicine’s safety. The EMA’s safety committee is currently reviewing data on skin cancer in patients using Picato. Final results from a study comparing Picato with imiquimod had indicated a higher occurrence of skin cancer in the treatment area with Picato than with imiquimod.


Medicines and Healthcare products Regulatory Agency

Resource links:

EMA statement