There have been several Picato recall announcements around the world during the past year. All of these are due to Picato skin cancer risk findings by drug safety regulators. As reported in this October 28, 2020 item, "Denmark’s LEO Pharma initiates Picato phase-out", published on thepharmaletter.com site: Following safety warnings on Picato … [Read more...]
When Will FDA Weigh-in On The Picato Skin Cancer Safety Issue?
Drug regulatory agencies in Europe and Canada have already taken action and made public announcements regarding this Picato safety issue, but the FDA is still investigating the Picato skin cancer risk. First, earlier this year the European Medicines Agency (EMA) investigation of the Picato safety issue, i.e., whether Picato increases skin … [Read more...]
Picato Skin Cancer Risk Confirmed In Europe; FDA Picato Review Ongoing
In April 2020 the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) confirmed that Picato increased risk of skin cancer findings outweigh Picato’s benefits as a treatment of actinic keratosis. We previously provided some background for this Picato drug safety issue in this January 2020 Drug Injury Watch blog … [Read more...]
Picato: Investigation Of Skin Cancer Risk By European Drug Regulator EMA
The European Medicines Agency (EMA) is investigating whether the use of Picato increases skin cancer risks. From this January 17, 2020 press release, “EMA suspends Picato as a precaution while review of skin cancer risk continues”, we get this information about these new concerns about the safety of Picato: EMA’s safety committee … [Read more...]