Xeloda killed my mother.   My only interest in making this assertion is so that others might benefit from the experience of our tragedy.  I am not writing to impugn the efficacy of capecitabine; it is in fact a chemotherapy drug that has helped thousands of people.  But the fact remains that Xeloda killed my mother.  Since her whole life was devoted to helping others, it's my fervent hope that her story can be of benefit to others who are facing the difficult challenges of chemotherapy with capecitabine.

What follows is the text of an Adverse Event Report that I filed today, February 20, 2008, with FDA MedWatch:

http://www.fda.gov/medwatch/index.html

My 83 year old mother suffered a perforation of her small intestine one month after beginning a regimen with the oral chemotherapy drug Xeloda (capecitabine).  At the time she was being treated for breast cancer metastasis on her liver.  CAT scans first revealed lesions in 2005; these grew significantly during 2007, prompting her oncologist to abandon other therapies and to prescribe Xeloda.  When she began the regimen, she suffered no apparent physical impairments in spite of her condition. 

She began a 1500 mg b.i.d. Xeloda regimen on (or about) 10/15/2007.  Her body size was  1.6 sq. meters. 1250 mg / sq. meter / b.i.d. is the manufacturer s recommendation; there are no guidelines for dosage reduction for geriatric patients based on information from Roche, the manufacturer.  At (or near) the end of her first 14-day cycle on 10/27/2007 she wrote to me in an e-mail that she was doing okay, with the exception of my queasy stomach.   Early in her second 14-day cycle she complained of hand-foot syndrome and diarrhea, for which she was prescribed generic Lomotil.  Her oncologist recommended a dosage reduction to 2000 mg / day, which I believe she began during that second cycle.  On 11/17/2007 she was hospitalized, complaining of severe dehydration.  Her last ingestion of Xeloda (1000 mg, I believe) occurred that morning.  On 11/23/2007 she suffered a perforation of her small intestine, which was repaired during emergency surgery early the next morning.  She tolerated the surgery well, and was moved from ICU to a surgical recovery floor on 12/10/2007.  From there, she was moved to a rehabilitation unit on 12/17/2007.  However, the trauma destroyed her will to live, and she complained frequently to nurses that she just wanted to die.   She developed pneumonia later that week and was returned to ICU on 12/24/2007.  She died on 12/27/2007.

I'm concerned about two potential drug interaction problems that may have been contributing factors to her adverse reaction to Xeloda.  My mother's diet was rich in folic acid, and it is probable that she continued to take a multivitamin with 100% RDA of folic acid during her treatment.  It may even be possible that she took a folic acid supplement.  Unfortunately, my sister disposed of my mother's vitamins before I had a chance to look at them; however, I distinctly remember seeing a large, half-filled bottle of standard multivitamins in her cabinet.  It appears that she was not advised to reduce her folic acid intake during her treatment with Xeloda. 

Of additional concern is her internal medicine physician's prescription of hydrochlorothiazide during my mother's Xeloda treatment.  The prescription of 25 mg once/day was filled on 9/11/07.  My mother consumed 58 of 100 tablets, indicating that she took this medication until at least the 8th of November.  She began taking Xeloda on or about the 15th of October. 

I found no drug interaction warnings on the FDA website, however, the site http://www.drugs.com  contains an entry with a warning about hydrochlorothiazide and Xeloda stating that it can cause prolonged bone marrow suppression: 

http://www.drugs.com/drug-interactions/hydrochlorothiazide_d00253_xeloda_d04311.html

Pertinent text of the warning is as follows:  "hydrochlorothiazide and capecitabine (Moderate Drug-Drug) 

MONITOR: Antineoplastic-induced bone marrow suppression may be prolonged with concomitant thiazide administration. The mechanism is unknown. Thiazides have been associated with blood dyscrasias.

MANAGEMENT: Alternative antihypertensive therapy may be advisable. Hematological status should be closely monitored in patients receiving this combination."

In my one conversation with my mother s oncologist after her death, he stated that a test on 10/31/2007 indicated blood count normal.

Following is a list of all medications that my mother had been prescribed in the period September November 2007:

Please be hyper vigilant if you are prescribed Xeloda, regardless of your age.  Stop taking multivitamins, review your diet, and try to eliminate foods that contain folic acid for the duration of your treatment.  If you are over 70,  challenge your doctor's dosage recommendations, because the manufacturer has established no guidelines.  My mother, at 83, took 75% of the manufacturer-recommended dosage for her size, and the drug killed her in a single month.  Please don't let this happen to you.  If you'd like more information about our case, feel free to contact me. Good luck to you.

James W. Moore

xeloda@jwmit.com

Useful links:

http://www.fda.gov/cder/consumerinfo/druginfo/xeloda.htm

http://www.springerlink.com/content/f5262525727l1200/

http://en.wikipedia.org/wiki/Xeloda

This site was designed by James W Moore.

http://helenmoore.org