ask about your risk of VERY serious side effects before starting 5-FU Chemotherapy

Petitions for change

In the the following pages of this section, you will find appeals to:

  • The US Food and Drug Administration (FDA) to change its label requirements for fluorouracil (5-FU) and Xeloda.
  • November 2020:   See the newest petition to the FDA that recommends pre-screening of patients along with a Box Warning on the drug labels for Fluorouracil and Xeloda.
  • In August 2016: The FDA granted a partial approval of the petitions. The FDA agreed to revise the drug warning label but denied the petition to require pre-screening. See  the FDA's Response July 2016
  • The National Comprehensive Cancer Network (NCCN) to revise its guidelines for the treatment of colon cancer and screen patients before administering treatment or to encourage lower initial doses of 5-FU.
  • The general public to learn the risk and to share the knowledge with friends and loved ones.