Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 January 2020

17 January 2020

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.

More information is available below.

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.

More information is available below.

Agenda

Agenda - PRAC draft agenda of meeting 13-16 January 2020

Draft Reference Number: EMA/PRAC/645087/2019

PRAC statistics: January 2020

PRAC statistics: January 2020

Glossary:

• Safety signal assessments. A safety signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under Signal management.
• Periodic safety update reports, abbreviated as PSURs, are reports prepared by the marketing authorisation holder to describe the worldwide safety experience with a medicine in a defined period after its authorisation. PSURs for medicinal products that contain the same active substance or the same combination of active substances, but have different marketing authorisations and are authorised in different EU Member States, are jointly assessed in a single assessment procedure. More information can be found under Periodic safety update reports: questions and answers.
• Risk management plans, abbreviated as RMPs, are detailed descriptions of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines. Companies are required to submit an RMP to EMA when applying for a marketing authorisation. RMPs are continually updated throughout the lifetime of the medicine as new information becomes available. More information is available under Risk-management plans.
• Post-authorisation safety studies, abbreviated as PASSs, are studies carried out after a medicine has been authorised to obtain further information on its safety, or to measure the effectiveness of risk-management measures. The PRAC assesses the protocols (aspects related to the organisation of a study) and the results of PASSs. More information can be found under Post-authorisation safety studies (PASS).
• Referrals are procedures used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral related to safety of medicines, the PRAC is requested by a Member State or the European Commission to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. More information can be found under Referral procedures.

Ongoing referrals

Procedure	Status	Update
Article-31 procedure: Cyproterone-containing medicinal products	Under evaluation	PRAC continued its assessment.
Article-20 procedure: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products	Under evaluation	PRAC continued its assessment.
Article-31 procedure: Leuprorelin-containing depot medicinal products	Under evaluation	PRAC continued its assessment.