The photochemical angular disease drug Picato has been decertified as ema with a carcinogenic risk.

The European Medicines Agency (EMA) Safety Committee (PRAC) has issued a notice confirming that Picato( the giant oxytol methyl butylene) product from Leo Pharma in Denmark for the treatment of photonopathic keratosis may increase the risk of skin cancer.
addition, the EMA cautions patients treated with Picato to be aware of skin abnormalities or growth that may occur within weeks to months of use and seek medical help if they occur.
January 2020, the EMA issued a review of the risk of cancer in the drug, while Picato was suspended in Europe as a precaution.
11 February, LEO Laboratories voluntarily requested that its sales license be revoked.
it is understood that the EMA review was based on two studies: a three-year study of 484 patients, which showed a higher incidence of skin malignancies (especially squamous cell carcinoma) in the skin area treated by Picato compared to imimodqui. The proportion of cancer in the
treatment group was 3.3%, compared with 0.4% in the comparison group.
another study, an eight-week contrast-control trial of excipients in 1,262 patients, showed a higher incidence of skin tumors in the Picato treatment group, at 1 percent, compared with 0.1 percent in the excipient group.
addition, in four clinical trials involving 1,234 patients, iningenol Disoxate, the rate of skin tumors was higher in the drug treatment group than in the shaper control group, at 7.7% and 2.9%, respectively.
because Inenol Disoxate is closely related to Picato, the results are considered relevant in the Picato review.
based on the above available data on the risk of skin cancer in all patients using Picato, the PRAC concluded that the risk of the drug outweighed the benefits and that Picato's effectiveness could not be maintained over time.
there are other treatment options for photochemical angular disease, so the EU no longer authorizes Picato sales.
Picato is a clear, colorless gel, mainly composed of the giant ingol methylbuterate (Ingenol Mebutate), a substance found in a plant's magenta juice that induces cell death.
at present, the mechanism of cell death caused by this cell death inducer is still not completely clear, but a study of squamous cell carcinoma has found that the treatment of large lycol methyl butyleneest is associated with cell death caused by the PKC/MEK/ERK signaling pathway, and photochemical keratio is an early stage that can develop into squamous cell cancer.
in addition, the giant ceylon medbutaylate may also induce the leukyl bait receptors IL1R2 and IL13RA2, resulting in reduced long-term cell viability, which may help prevent recurrence of the skin disease.
the molecular structure of ingenol Mebutate (from wikipedia) photochemical angularization is a scaly sclerosis on the skin whose lesions may be red or yellow.
often located in areas exposed to sunlight, such as the face, scalp, back of the hand, and chest.
most of these lesions are harmless to humans, photochemical triangular diseases can sometimes develop into skin cancer.
January 2012, Picato was approved by the FDA for local treatment of cycpatopathy, and in November of the same year, it was approved by the EMA. According to
website, Picato ® gel (0.015%) is used to treat photoged keratosis on the face or scalp, and Picato ® gel (0.05%) is used to treat photososome keratosis in the body or arms and legs.
has not been approved for use in patients under the age of 18.
August 2015, the FDA issued a warning that the use of Picato gels could cause severe allergic reactions such as swelling of the lips or tongue, chest urgency, difficulty breathing or wheezing, dizziness or fainting, and shingles.
, the FDA also received reports of cases of severe eye damage and skin reactions associated with Picato gel applications, such as redness, skin peeling, bruising, or swelling.
the most common side effects are pain in the treatment area, itching, skin irritation, infections, as well as swelling around the eyes, irritation of the nose and throat, headaches, but no cancer-related risks mentioned.
Reference Source: 1, EMA confirms skin cancer risk LEO's Picato 2, EMA review of Pica concludo to medicine's risk benefits its 3, FDA SafetY Drug Communications: FDA warns of the severe d'oedd satos with use of Picato (ingenol meate)