The European Medicines Agency (EMA) has started a review of medicines containing fluorouracil and the related therapies; capecitabine, tegafur and flucytosine. The review will examine the latest evidence to determine if existing screening methods for dihydropyrimidine dehydrogenase (DPD) deficiency are sufficient.
The review has been initiated at the request of the French medicines agency, ANSM, following the recent publication of new information on DPD screening methods. Based on the new data, the ANSM considers that the product information of systemic fluorouracil and its prodrugs (capecitabine and tegafur) does not reflect current evidence.
As part of the review, the EMA will carry out a EudraVigilance analysis of reports of DPD deficiency-related toxicity with fluorouracil and fluorouracil-related substances and flucytosine-containing medicinal products.
The marketing authorisation holders (MAHs) have been requested to provide figures on the number of patients treated with these medicines in 2018, the frequency of partial and full DPD deficiency in the European Union, and data on the prevalence of serious and fatal toxicity in patients with DPD deficiency and in patients with normal DPD activity.