Drugs and FDA
FDA urges DPD deficiency discussions before capecitabine or fluorouracil treatment
FDA says providers should test for DPYD variants before starting capecitabine or fluorouracil, unless immediate treatment is necessary.
The FDA urges healthcare providers to inform patients about the risks of DPD deficiency and test for genetic variants in DPYD before starting capecitabine or fluorouracil, unless immediate treatment is necessary. The agency recently approved labeling revisions for both medicines to provide more information about DPD deficiency.
The DPYD gene encodes the DPD enzyme, which breaks down >80% of fluorouracil, according to the FDA. People with certain variants that cause complete or near-complete absence of DPD activity face increased risk of acute early-onset toxicity and serious, sometimes fatal, reactions, including mucositis, diarrhea, neutropenia and neurotoxicity. People with partial DPD activity may also face increased risk of serious, including fatal, reactions. The FDA said it will continue monitoring the safety issue and may consider further regulatory actions.
