EMA suspends Picato as a precaution while review of skin cancer risk continues
Press release
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EMA is recommending that patients stop using Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine’s safety.
EMA’s safety committee (PRAC) is currently reviewing data on skin cancer in patients using Picato. Final results from a study comparing Picato with imiquimod (another medicine for actinic keratosis) indicate a higher occurrence of skin cancer in the treatment area with Picato than with imiquimod.
While uncertainties remain, there is concern about a possible link between the use of Picato and the development of skin cancer. The PRAC has therefore recommended suspending the medicine’s marketing authorisation as a precaution and noted that alternative treatments are available.
The PRAC will continue its review and when the review has concluded, EMA will provide updated guidance to patients and healthcare professionals.
Information for patients
Information for healthcare professionals
A direct healthcare professional communication (DHPC) will be sent to relevant healthcare professionals on or around 27 January 2020. The DHPC will also be published on a dedicated page on the EMA website.
More about the medicine
Picato is available as a gel which is applied to skin areas affected by actinic keratosis. It is used when the outer layer of the affected skin is not thickened or raised. Actinic keratosis is caused by too much sunlight exposure and can turn into skin cancer.
Picato has been authorised for use in the EU since November 2012.
More about the procedure
The review of Picato has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines. While the review is ongoing, the PRAC has recommended suspending the medicine as an interim measure to protect public health. The recommendation will now be forwarded to the European Commission (EC), which will issue a provisional legally binding decision applicable in all EU Members States.
Once the PRAC review is concluded, the final recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt an opinion. The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.