EMA Suspends Leo’s Actinic Keratosis Drug Picato

Also Limits Use Of High-Strength Estradiol Creams

The latest drug safety actions by the European Medicines Agency affect products for dermatological use and vaginal atrophy.

Suspended
The EMA has suspended an actinic keratosis drug over safety concerns • Source: Shutterstock

The European Medicines Agency has suspended the use of Picato, an ingenol mebutate-containing product for actinic keratosis, because of concern over its propensity to cause skin cancer.

The EMA’s pharmacovigilance committee, the PRAC, has also confirmed its recommendation that high-strength estradiol-containing creams should be used for a maximum of four weeks to avoid the possibility of

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