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# FDA Approves, Denies Xeloda Labeling Change Petition
- URL: https://www.fdaweb.com/fda-approves-denies-xeloda-labeling-change-petition/
- Published: 2016-08-02T12:00:00.000Z
- Updated: 2026-09-14T21:20:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136368

FDA has approved in part and denied in part petitions filed by **Ken Suprenant**, a Michigan man whose wife died from rare adverse effects of chemotherapy, asking that the agency revise prescribing information for fluorouracil injection and Xeloda (capecitabine) to clarify the risk of severe toxic reactions in patients with impaired dihydropyrimidine dehydrogenase (DPD) activity. The petitions also contended that prescreening patients for DPD deficiency and proper dose management of the products could effectively reduce the risk of severe toxic and fatal reactions.

The agency [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2014-P-0497-0009&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) says that changes to Xeloda prescribing information were approved 3/20/15 and changes to fluorouracil prescribing information were approved as of 7/29, the date of the petition response. “Although the changes do not include the prescreening and dose management provisions you requested,” it says, “they do clarify the risk of severe toxic reactions in patients with impaired DPD activity as you sought.”

FDA says that existing DPD screening tests are unreliable and the agency is concerned that adding a contraindication that would rely on such testing could result in an effective drug being withheld from patients who could tolerate and benefit from it. It also says that the potential benefit of fluorouracil treatment may make the risk of adverse reactions acceptable for some patients with impaired DPD activity and thus a blanket contraindication would not be appropriate.