A security alert has been issued through its digital portal to inform that the “suspension of marketing as a precautionary measure pending the completion of the ongoing European evaluation” of the drug Picato (Ingenol Mebutate).
“Pharmacovigilance Risk Assessment Committee (PRAC) is currently evaluating the risk of skin cancer associated with the administration of Picato. As a precautionary measure while this evaluation is finalized, it has considered it necessary to suspend the commercialization of the drug. and establish the following recommendations:
Do not start new treatments and assess the use of other therapeutic alternatives.
Inform patients treated with Picato in detail so that when new skin lesions appear, they consult their doctor.
Do not dispense this medicine and inform patients that they should see their doctor.
Patients currently using Picato should discontinue its application and consult their doctor.
As , Picato “whose active ingredient is ingenol mebutate, is a topical medication indicated for the treatment of non-hyperkeratotic and non-hypertrophic actinic keratosis in adults. 150 micrograms/gram gel (for administration to the face and scalp) and 500 micrograms / gram gel (for administration in the trunk and extremities)”. The agency ensures that the Committee for the Evaluation of Risks in Pharmacovigilance “is currently evaluating both the most recent data and the accumulated information related to said risk. The data under review are those from clinical trials, non-clinical studies and notification of suspected adverse reactions.
At this time, the most relevant information in relation to the aforementioned evaluation is the following:
The results of a clinical trial carried out during three years of follow-up in 484 patients have shown a greater number of cases of squamous cell carcinoma in the group treated with ingenol mebutate versus the group treated with imiquimod (3.3% versus 0.4% respectively).
Uncertainties remain regarding the mechanism of action by which the drug could intervene in the development of skin tumorsas well as the influence of a possible protective effect of imiquimod and possible biases due to lack of blinding in some studies.
“Based on these data, and since it currently cannot be ruled out an increased risk of developing skin cancer associated with ingenol esters, the PRAC has concluded that the benefit-risk ratio of Picato is unfavorable considering it necessary to suspend the marketing authorization of the drug”, reported from the AEMPS, which also recommends health professionals “not to start new treatments with Picato”, “Give detailed information to patients treated with Picato so that they remain alert to the appearance of new skin lesions and in such cases consult their doctor” and , finally notify “those patients who are currently using it who must suspend its application and consult with your doctor to assess the most appropriate therapeutic alternative in each specific case”.