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European Medicines Agency’s review of Picato finds its risks outweigh its benefits

Published on 24/04/20 at 01:12pm
Photo by Lovesevenforty

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the risks from using Picato are too high to end its suspension.

Picato is a gel for treating the skin condition actinic keratosis. It was suspended in the EU as a precaution in January. In February, LEO Laboratories Ltd, the company that marketed the medicine, asked the EMA to withdraw its marketing authorization for the treatment.

The PRAC’s conclusion came after a review of all available data on the risk of skin cancer in patients taking Picato. This included the results of a study comparing Picato with a rival treatment for the same condition, called imiquimod. The study showed that there was a higher occurrence of skin cancers in area of the skin treated with Picato compared to areas treated with imiquimod.

The EMA is urging patients who have used Picato to look out for growths or unusual skin changes that can form weeks or even months are using the gel, and to contact their doctor immediately if these abnormalities manifest.

The PRAC will now send its recommendation to the Committee for Medicinal Products for Human Use (CHMP) which will likely adopt the Agency’s opinion. The final step is for the European Commission to adopt a legally binding decision that will be applicable in all EU member states in regard to Picato.

Conor Kavanagh

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