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 article, “Picato Skin Cancer Risk Investigation By European Drug Regulator Prompts Sales Suspension In Europe”.
An Arpil 17, 2020 European Medicines Agency (EMA) press release, “EMA review of Picato concludes medicine’s risks outweigh its benefits”, noted the Picato increased risk of skin cancer findings in comparison to another actinic keratosis treatment, imiquimod. That April 2020 EMA Picato press release went on to point out:
The study showed a higher occurrence of skin cancers, especially squamous cell carcinoma, in areas of skin treated with Picato than in areas treated with imiquimod….
Patients who have been treated with Picato should look out for unusual skin changes or growths, which may occur from weeks to months after use, and seek medical advice if any occur.
As mentioned in our January 2020 article about this Picato skin cancer risk, the FDA is investigating this Picato drug safety issue. We will monitor the FDA Picato investigation for any significant drug regulatory actions such as a Picato recall or Picato drug label change with new warnings about the skin cancer risk.[Read article in full at original source]