Increased risk of skin cancer: EU adopts Gel from the market and warns of application
Because it could increase the risk for skin cancer, warns the EU Commission is now before the application of the Arzneigels Picato. The agent is supposed to treat precursors of skin cancer, has now been taken but for the time being from the market.
The medicinal product Picato with the active ingredient Ingenolmebutat could be associated with the development of skin cancer. Prior to that, the Federal Institute for drugs and medical devices (BfArM) now warns.
Patients should apply the Gel so. Picato is used for the treatment of actinic keratoses, precursors of skin cancer. The European Commission also ordered provisional suspension of the marketing authorisations. Thus the drug is no longer marketable.
The Federal Institute for drugs and medical devices advises patients therefore:
- Patients should not apply Picato for the treatment of actinic keratoses, as long as the data to be checked
- Patients should be aware of unusual skin changes or growths and the appearance of new skin lesions, consult a doctor immediately
- If you have any questions, talk with your doctor
Currently, the Committee for risk assessment checks in the area of pharmacovigilance (PRAC) data on skin cancer in patients apply Picato. In comparison with other drugs had previously been shown to be at a higher risk of skin cancer, if the affected areas were treated with Picato.Click here to read: diagnosis of black skin cancer is not a death sentence anymore
The PRAC will continue its Review to continue. When this is completed, the European medicines Agency (EMA) patients ‘ and physicians-to-date guidance available.
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