EMA suspends Picato as a precaution while review of skin cancer risk continues

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.

The PRAC is currently reviewing data on skin cancer in patients using Picato. While uncertainties remain, there is concern about a possible link between the use of Picato and the development of skin cancer. The PRAC has therefore recommended suspending the medicine’s marketing authorisation as a precaution and noted that alternative treatments are available.

PRAC confirms four-week limit for use of high-strength estradiol creams

Following a re-examination procedure, the PRAC has confirmed its recommendation to minimise the risk of side effects from high-strength estradiol creams.

In October 2019, the PRAC concluded that the use of creams containing 100 micrograms/gram (0.01%) of estradiol should be limited to a single treatment period of up to four weeks. This measure is intended to minimise the risk of side effects caused by estradiol that is absorbed into the bloodstream from creams applied inside the vagina to treat symptoms of vaginal atrophy in post-menopausal women.

Posted on the EMA website on 17 January 2020