EMA has completed its review of Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, and concluded that the medicine may increase the risk of skin cancer and that its risks outweigh its benefits.
The European Medicines Agency's safety committee (PRAC) has confirmed that LEO's Laboratories' Picato (ingenol mebutate), used to treat the skin condition actinic keratosis, may increase the risk of skin cancer.
The European Medicines Agency (EMA) said Friday it’s now publishing all safety communications sent directly to health professionals by marketing authorization holders (MAHs) and competent authorities on its website.
Ingenol mebutate gel (Picato): suspension of the licence due to risk of skin malignancy
LEO Pharma has recalled all unexpired stock of Picato (ingenol mebutate) on precautionary grounds, after concerns have arisen on the possible risk of skin malignancy.
At its January meeting, EMA’s safety committee (PRAC) recommended that patients stop using Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine’s safety.
Advise patients treated with ingenol mebutate gel to be vigilant for new skin lesions and to seek medical advice immediately should any occur. Use with caution in patients with a history of skin cancer.
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) on Friday announced that it’s begun reviewing data on skin cancer in patients using Picato (ingenol mebutate), a gel for treating actinic keratosis, which is a skin condition caused by excessive sun exposure.
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