Other safety alerts
|
| |
| European Union: EMA review of Picato concludes medicine’s risks outweigh its benefits |
| |
The European Medicines Agency (EMA) announces that EMA’s safety committee, Pharmacovigilance Risk Assessment Committee (PRAC), has confirmed that Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, may increase the risk of skin cancer and concluded that the risks of the medicine outweigh its benefits.
The conclusions are based on a review of all available data on the risk of skin cancer in patients using Picato, including results of a study comparing Picato with imiquimod (another medicine for actinic keratosis). The study showed a higher occurrence of skin cancers, especially squamous cell carcinoma, in areas of skin treated with Picato than in areas treated with imiquimod.
The PRAC also considered that Picato’s effectiveness is not maintained over time and noted that other treatment options are available for actinic keratosis. Picato is no longer authorised in the European Union. In Jan 2020, Picato was suspended as a precaution while the review was underway. On 11 Feb 2020, the marketing authorisation was withdrawn at the request of LEO Laboratories Ltd, the company that marketed the medicine.
Patients who have been treated with Picato should look out for unusual skin changes or growths, which may occur from weeks to months after use, and seek medical advice if any occurand. Patients who have questions or concerns about their treatment should consult their doctor or pharmacist.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/ema-review-picato-concludes-medicines-risks-outweigh-its-benefits
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by MHRA and EMA, and was posted on the Drug Office website on 19 Oct 2019, 18 Jan 2020, 29 Jan 2020 and 13 Feb 2020.
Ends/ Saturday, Apr 18, 2020
Issued at HKT 12:30
|
| |
|
