Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 September-3 October 2019

News 04/10/2019

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

EMA’s safety committee (PRAC) has recommended limiting the use of high-strength creams containing 100 micrograms/gram (0.01%) of estradiol to a single treatment period of up to four weeks. This measure is intended to minimise the risk of side effects such as blood clots, strokes and certain types of cancer caused by estradiol absorbed into the bloodstream from creams applied inside the vagina to treat symptoms of vaginal atrophy in women who have been through menopause.

The PRAC has reviewed all available data on the safety and effectiveness of high-strength estradiol-containing creams, including on the amount of estradiol in blood. These data showed that in postmenopausal women who had used these creams, the levels of estradiol in the blood were higher than normal postmenopausal levels.

The prescribing information for these creams will be updated with the new recommendations. A warning that the medicine is to be used for a single treatment period of up to 4 weeks only will be placed on the outer and inner packaging, and the size of the tube will be limited to 25 grams to prevent use for longer than recommended.

This review was initiated in April 2019 at the request of the European Commission, following a ruling by the EU Court of Justice that partially annulled the conclusions of a previous PRAC review of these medicines in 2014 on procedural grounds. Although the Court of Justice did not question the scientific conclusions, the partial annulment meant that some of the measures taken to minimise the risk were invalidated.

More information is available below.

PRAC statistics: October 2019

PRAC statistics: October 2019

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 underReferral procedures.

Ongoing referrals

Procedure

Status

Update

Article-31 procedure: Cyproterone-containing medicinal productsUnder evaluationPRAC continued its assessment

Article-31 procedure: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products

Under evaluation

PRAC adopted a list of experts for the ad-hoc inter-Committee Scientific Advisory Group on Oncology (SAG-O).

Article-20 procedure: Lemtrada

Under evaluation

PRAC adopted a list of outstanding issues (LoOI).

Article-31 procedure: Leuprorelin-containing depot medicinal products

Under evaluation

PRAC continued its assessment
Article-20 procedure:PicatoUnder evaluationPRAC continued its assessment
Article-20 procedure: XeljanzUnder evaluationPRAC adopted a list of outstanding issues for marketing authorisation holders and a list of questions for the ad-hoc expert group

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