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Warning: Risk of skin cancer from preparations for the treatment of actinic keratoses

Warning: Risk of skin cancer from preparations for the treatment of actinic keratoses


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Discontinue use of agents for the treatment of skin actinic keratoses

Actinic keratosis caused by excessive UV radiation is considered the most common pre-stage skin cancer. It should always be treated. But not with Picato®. Because studies that compared the drug with another preparation indicate a higher risk of skin cancer.

The European Medicines Agency (EMA) recommends that patients stop using Picato® (Ingenol mebutate), a gel for the treatment of actinic keratoses on the skin. As the Federal Institute for Drugs and Medical Devices (BfArM) reports, the safety of the drugs is still being checked.

The most common skin cancer precursor

According to the Techniker Krankenkasse (TK), actinic keratosis is the most common pre-stage skin cancer - triggered by excessive UV radiation. If left untreated, it often turns into a malignant form of skin cancer.

According to the health insurance company, there are several therapies that can successfully treat actinic keratosis:

Icing (also cryosurgery or cold therapy), photodynamic therapy (PDT), laser therapy, surgical removal and ointment treatment. If the latter treatment is used, then Picato® should not be used.

Alternative treatments

As reported by the BfArM, the Pharmacovigilance Risk Assessment Committee (PRAC) is currently reviewing data on skin cancer in patients using Picato®.

According to the information, the final results of a study comparing Picato® to imiquimod (another medicine for actinic keratosis) indicate a higher risk of skin cancer in the treated area after using Picato® compared to imiquimod.

Because of concerns about a possible link between the use of Picato® and the development of skin cancer, the PRAC recommended that drug approvals should be suspended as a precaution and also noted that alternative treatments are available.

According to the announcement, the PRAC will continue its review. When this is complete, the EMA will provide updated guidelines to patients and healthcare professionals.

Information for patients

The BfArM has summarized important information for patients:

  • There are concerns about the relationship between the use of Picato® and the development of skin cancer.
  • Patients should no longer use Picato® to treat actinic keratoses while the data is being reviewed.
  • Patients should pay attention to unusual skin changes or growths and consult a doctor immediately if new skin changes occur.
  • If you have any questions, talk to your doctor.

Pay attention to new skin changes

According to the BfArM, healthcare professionals should stop prescribing Picato® and consider other treatment options while the data is being reviewed.

In addition, they should ask the patient to pay attention to new skin changes and to see a doctor immediately if they occur.

EMA is reportedly continuing to review the available data and will provide further information when the review is complete. (ad)

Author and source information

This text corresponds to the requirements of the medical literature, medical guidelines and current studies and has been checked by medical doctors.



Video: Actinic Keratosis Dermatology (May 2022).