EU Panel Starts Safety Review of Ingenol Mebutate (Picato) Gel

Megan Brooks


September 06, 2019

At the request of the European Commission, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has launched a review of ingenol mebutate gel (Picato, Leo Laboratories), used to treat adults with actinic keratosis.

"The review was triggered by data from several studies showing a higher number of skin cancer cases, including cases of squamous cell carcinoma, in patients using ingenol mebutate," the EMA said in a statement.

Ingenol mebutate was authorized for use in the European Union in late 2012.

In 2017, the product information for ingenol mebutate was updated to reflect an "excess" of skin tumors (keratoacanthoma). Following a separate review, this warning is now being updated to mention basal cell carcinoma, Bowen disease, and squamous cell carcinoma, the EMA said in a referral document.

"In order to conclude on whether Picato increases the risk of skin cancer, the PRAC will now carry out a thorough review of all available data, including from ongoing studies. The Committee will assess the impact of the data on the benefit-risk balance of Picato and recommend whether the medicine’s marketing authorization in the EU should be amended," the EMA said.

For now, the agency advises healthcare providers to use Picato "with caution" in patients who have a history of skin cancer. In addition, patients should be advised to watch for any skin lesions and to inform their physician immediately if they notice anything unusual.

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