EMA's PRAC gives latest guidance on fluorouracil, flucytosine and ulipristal

14 March 2020
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As a result of discussions at its March 9-12 meetings, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that patients receiving fluorouracil given by injection or infusion (drip) and the related medicines capecitabine and tegafur, which are converted to fluorouracil in the body, should be tested for the lack of an enzyme called dihydropyrimidine dehydrogenase (DPD) before starting treatment.

For flucytosine, another medicine that gets converted to fluorouracil in the body, pre-treatment testing is not required, in order not to delay start of treatment of patients with severe yeast and fungal infections, including some forms of meningitis.

No pre-treatment testing is needed for patients treated with topical fluorouracil (applied to the skin to treat various skin conditions).

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