In a new release from European Medicines Agency (EMA), Pharmacovigilance Risk Assessment Committee (PRAC) stated that ingenol mebutate may increase the risk of skin cancer and concluded that risks for ingenol mebutate medicine are greater than its benefits.

On 09-May-2019, PRAC initiated the procedure of review for assessing the benefit risk profile for ingenol mebutate and completed on 17-Apr-2020 with the outcome of suspension of this medicine.

Picato (ingenol mebutate) is used for treatment of actinic keratosis, in a gel formulation marketed by LEO Laboratories. This medicine is authorized in Europe since November 2012.

On 21-Aug-2015, USFDA released a safety communication with a warning that ingenol mebutate use is associated with severe skin allergic reactions and herpes zoster (shingles) based on the case reports received from post marketing surveillance into FAERS.

The review on benefit risk (BR) profile for this medicine has been initiated by European Commission, as part of referral procedures. During the process of review by safety committee, on 16-Jan-2020, EMA (PRAC) recommended suspension of Picato marketing authorization due to potential risk of skin cancer. This recommendation is followed by issue of legal binding decision by European commission (EU) to suspend marketing authorization. On 11-Feb-2020, EU withdrawn the marketing authorization of this medicine as per the request from its manufacturer.

A Phase-4 interventional clinical study (NCT01926496) was conducted for comparison of risk of squamous cell carcinoma on skin areas between ingenol mebutate and imiquimod (another medicine for actinic keratosis). The study results showed a higher occurrence of skin cancers, (especially squamous cell carcinoma), in areas of skin treated with ingenol mebutate than in areas treated with imiquimod. The conclusion of PRAC on this medicine’s BR profile is based on the evidence of skin cancer risk in patients treated ingenol mebutate from this study results

The safety committee also considered that effectiveness of ingenol mebutate is not maintained over time and identified the alternative treatment options available for treatment of actinic keratosis.

EMA advised patients who have been treated with ingenol mebutate to look for unusual skin changes or growths which usually appears after weeks or months of the medicine use and seek the immediate medical treatment for any unusual occurrences.

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