According to the Medicines Agency, this gel prescribed to treat actinic keratosis, a skin disease resulting from too much exposure to UV rays, would increase the risk of developing skin cancer.
Picato gel, prescribed to treat actinic keratosis, should no longer be marketed and used. In a warning dated Friday, January 17, the National Agency for Medicines and Health Products (ANSM) announced that the European Commission was suspending “as a precautionary measure” the marketing authorization for Picato gel.
It follows the recommendations of the European Medicines Agency (EMA) which, since September 2019, had highlighted the potential risk of skin cancer in the area treated with this medicine.
A risk of skin cancer
Also called solar keratosis, actinic keratosis is a skin disease characterized by rough lesions resulting from excessive exposure to UV rays from the sun or artificial rays. Considered to be pro-carcinogenic, this pathology often leads to the development of skin cancers, and in particular squamous cell carcinomas.
According to the ANSM, however, the benefit/risk ratio of Picato gel is unfavorable because it can itself promote the appearance of skin cancer. This drug indeed contains ingenol mebutate, which “is subject to special monitoring on a possible increased risk of certain skin cancers, in particular squamous cell carcinomas, in the treated area”, develops the health agency. .
Pending conclusions on the re-evaluation of Picato, the drug therefore sees its marketing authorization. “We are therefore asking doctors to no longer prescribe this treatment, pharmacists to no longer dispense it and patients to no longer use it. If new skin lesions, growths or unusual symptoms appear, we recommend that patients consult their doctor”, writes the ANSM.
No consequence on discontinuation of treatment
According to Alban Dhanani, director of drugs in dermatology at ANSM, stopping treatment is not harmful. “It is a short treatment, two to three days, and stopping it has no consequence. There are other local treatments to put on the skin (5-FU and imiquinod)” , he explained to AFP. Any past use of Picato gel is also not serious.
“Be alert to any new skin lesions, growths or any unusual symptoms. In these cases, contact your doctor. In general, consult your dermatologist or your general practitioner regularly if you have actinic keratoses” , advises the ANSM.
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