Ann Fonfa wrote this letter to FDA trying to understand our options. It seems that sometimes drugs are approved (FDA-approved label) at levels that may subsequently be shown to be high. That is patients suffer unnecessary (perhaps) levels of toxicity. That seems to be the case with Xeloda (capcetabine). On Monday, December 3, 2001, I heard a second oncologist discuss the fact that Xeloda (oral chemotherapy) is best utilized at much lower doses than on the FDA-approved label. This doctor, Daniel Budman (Long Island-based) echoed a talk by Charles Vogel (Florida-based) where it was stated that doctors 'in the know' give their patients less Xeloda per treatment dose. I asked Dr. Budman why the label was not changed. Both he and the representative from Roche (manufacturer) agreed that it would not happen by request of the company since it would cost a lot of (extra) money and take time. It is our understanding that FDA does not initiate these changes itself. Dr. Budman suggested that 'most' oncologists learn about the lowered doses by attending meetings or reading journal articles. As patients, we have to respectfully disagree. We know from past experience that many doctors are not up-to-date on all the issues. There are so many issues these days and changes come regularly. Further, it is completely unfair to the patient population to have doctors 'in the know' use a dose different from FDA-approved levels. This can easily create a two-tiered system, failing patients whose doctors are NOT in-the-know. Please advise what steps FDA will take to correct this imbalance and unfair situation it has helped to create? A summary of Dr. Budman's remarks will shortly be posted on our website, adding to the meeting summaries we offer to patients and healthcare providers at www.annieappleseedproject.org Subsequent to this letter, I had the opportunity to ask an FDA director about this problem. I received a conference call from several FDA people. Advocate Musa Mayer participated. We remain very concerned about this. I had interviewed a variety of doctors at the San Antonio Breast Cancer Symposium 2001, asking them what dose of Xeloda they used for their patients. Without exception these doctors responded with a dose LESS than the accepted/approved label. The range was 1500-1800-2000 mgs BID (twice a day). The approved label states that the dose is 2500 mgs BID. One doctor suggested that if an oncologist administered this drug and the patient suffered from toxicity, the doctor would reduce the dose. Two things wrong with this: Why should these patients suffer if "doctors in the know" give a lower dose to begin with. (thus demonstrating the higher dose is unnecessary). And what if the doctor does not lower the dose? Plus the dose received might already have triggered unreversable unwanted (side) effects. This is a problem for patients. A problem for FDA (where the drug's sponsor has to ask for a change-which is unlikely because it could cost BIG BUCKS) and a problem for the drug manufacturer because advocates are taking up this issue. Ann Fonfa, 11/02 Article from The Oncologist, 11/02 2002 Ann Oncol, 5/05 Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.