EMA suspends Picato as a precaution while review of skin cancer risk continues

At its January meeting, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended 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.

Picato is a drug from independent Danish drugmaker LEO Pharma that received approval from the US Food and Drug Administration in January 2012 and in Europe in November of that year

The PRAC is currently reviewing data on skin cancer in patients using Picato. 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 authorization as a precaution and noted that alternative treatments are available.