Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 12-15 March 2019

Press release 15/03/2019

PRAC starts review on screening patients before treatment with fluorouracil, capecitabine, tegafur and flucytosine to decrease the risk of side effects

EMA’s safety committee (PRAC) has started a review of medicines containing fluorouracil (also known as 5-fluorouracil or 5-FU) and the related medicines capecitabine, tegafur and flucytosine, which can be converted to fluorouracil in the body.

Fluorouracil (given by injection), capecitabine and tegafur are cancer medicines, whereas topical (applied to the skin) fluorouracil is used for various skin conditions; flucytosine is a medicine used in severe fungal infections.

The review will examine existing screening methods and their value in identifying patients with low levels or complete lack of dihydropyrimidine dehydrogenase (DPD), an enzyme necessary to break down fluorouracil, as these patients are at an increased risk of severe side effects.

More information is available below.

Ongoing referrals

Procedure

Status

Update

Article-31 procedure: Methotrexate containing medicinal products

Under evaluation

PRAC continued its assessment

Article 107i procedure:Fenspiride containing medicinal productsUnder evaluationPRAC continued its assessment

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