Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2019

News 12/04/2019

Use of multiple sclerosis medicine Lemtrada restricted while PRAC review is ongoing

EMA's safety committee (PRAC) has started a review of the multiple sclerosis medicine Lemtrada (alemtuzumab) following new reports of immune-mediated conditions, which are caused by the body's defence system not working properly, and problems with the heart and blood vessels with this medicine, including fatal cases.

While the review is ongoing, Lemtrada should only be started in adults with relapsing-remitting multiple sclerosis that is highly active despite treatment with at least two disease-modifying therapies (a type of multiple sclerosis medicine) or where other disease-modifying therapies cannot be used.

Relapsing-remitting multiple sclerosis is a type of multiple sclerosis characterised by flare-ups of symptoms, followed by a time of recovery with few or no symptoms.

In addition to the restriction, the PRAC has recommended an update of the product information for Lemtrada to inform patients and healthcare professionals about cases of immune-mediated conditions, problems with the heart and blood vessels and severe neutropenia.

Patients being treated with Lemtrada who are benefitting from it may continue treatment in consultation with their doctor.

More information is available below.

New review of risks with high-strength estradiol-containing creams

The PRAC has started a new review of high-strength estradiol containing creams (100 micrograms of estradiol present per gram of cream) that are used for treating women with vaginal atrophy who have been through menopause.

The Committee will assess the risk of estradiol being absorbed systemically (throughout the body) from these creams, which may result in side effects that include venous thromboembolism (formation of blood clots in the veins), stroke and endometrial cancer (cancer of the lining of the womb).

In 2014, EMA completed a review of the risk of systemic absorption with high-strength estradiol creams and recommended measures to minimise it. However, in March 2019 the EU Court of Justice partially annulled the conclusions of the review on procedural grounds. Although the Court of Justice did not question the scientific conclusions, the partial annulment means that some of the measures taken to minimise the risk have been invalidated. The European Commission has therefore initiated a review at EU level.

The PRAC will now review all available data and recommend measures that should be implemented to protect patients.

More information is available below.

Start of referral - Article 20 referral

Ongoing referrals




Article 107i procedure:Fenspiride containing medicinal products

Under evaluation

PRAC continued its assessment

Article-31 procedure:Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal productsUnder evaluationPRAC continued its assessment
Article-31 procedure: Methotrexate containing medicinal productsUnder evaluationPRAC continued its assessment

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