UPDATE March 18th 2012
If your on this site hopefully you are searching for more info prior to receiving treatment and not due to drug toxicity. To ensure proper testing please be aware that the DPYD gene is not the only gene responsible for the metabolism of this drug, this is important as most labs only test for the DPYD gene and can be very misleading and dangerous as there are other genetic mutations responsible for allergic reactions. So do not only test or rely on the DPYD gene, as the drugs pamphlet and physicians mention.
Whats the solution? www.Aruplab.com (not affiliated to this site) However they are the only lab that I'm aware of that tests for 8 total genes. MTHFR and TYMS were the cause of my reaction. Both not mentioned in the prescribing packet, thanks to Arup labs we are able to pin point the cause of the severe reaction by testing for extra genetic mutation other then the DPYD or DPD.
Physicians are too arrogant and ignorant and will discount your symptoms as flu, viruses, or something none related to a 5-Fu reaction. This is the FDAs fault for not educating and mandating testing before administrating this drug. I'm averaging a case per quarter thru this site, a complete ban on this drug is not the answer as this drug helped save many peoples lives, but its a Russian Roulette game and the FDA is watching. I urge you to fill out the adverse reaction form and submit it to the FDA.
Before I start my story which wont be on the home page, I will start by warning anyone deciding or offered to take 5-Fluorouracil to get tested for the DPD Enzyme deficiency test.
My goal is to mandate DPD or DPYD testing ( a cheap and readily available test) before prescribing or injecting anyone with 5-FU. One topical application has the potentials of killing you if your DPD Deficient. As it Almost took my life away from three small applications and now suffering permanent damage at a young age for no reason.
So get tested before even touching the tube. If the FDA is on this page, enough people have died for absolutely no reason, all could have been avoided with a simple $300 test.
- From valeants pamphlet, it seems they are aware it can be life threatening, but its RARE so its OK.
- And you should discontinue therapy if you get the life threatening side effects, oh REALLY.
- And only one case has been reported but somehow Iam in contact with 3 others at the moment.
Patients should discontinue therapy with Efudex if symptoms of DPD
enzyme deficiency develop (see CONTRAINDICATIONS section).
Rarely, life-threatening toxicities such as stomatitis, diarrhea, neutropenia,
and neurotoxicity have been reported with intravenous administration of
fluorouracil in patients with DPD enzyme deficiency. One case of lifethreatening
systemic toxicity has been reported with the topical use of
Efudex in a patient with DPD enzyme deficiency. Symptoms included
severe abdominal pain, bloody diarrhea, vomiting, fever, and chills.
Physical examination revealed stomatitis, erythematous skin rash, neutropenia,
thrombocytopenia, inflammation of the esophagus, stomach, and
small bowel. Although this case was observed with 5% fluorouracil
cream, it is unknown whether patients with profound DPD enzyme deficiency
would develop systemic toxicity with lower concentrations of topically
PRECAUTIONS: General: There is a possibility of increased absorption
through ulcerated or inflamed skin.
Full link Old link
They moved it to this new link below.
- According to the Blue-cross Blue-shield, 30% of the people getting this obtain severe toxicity.
- So why not make it mandatory to get tested before killing and breaking up families for no reason.
- This is by far the best paragraph I found. Thank you Blue-Cross.
Severe toxicity occurs in about 30% of patients treated with 5-fluorouracil (FU)-based chemotherapy
The FDA-approved labels for both 5-FU and the 5-FU prodrug capecitabine (Xeloda®, Genentech)
contain the following warning: “Rarely, unexpected, severe toxicity (e.g., stomatitis, diarrhea,
neutropenia, and neurotoxicity) associated with 5-fluorouracil has been attributed to deficiency
of dipyrimidine dehydrogenase activity.” In addition, the capecitabine label contains the
following statements; “Xeloda® is contraindicated in patients with known dihydropyrimidine
dehydrogenase (DPD) deficiency.” However, the labels are silent regarding testing for DPD deficiency
in advance of treatment, nor do they provide guidance on how to reduce 5-FU
dosage when DPYD mutations are detected.
- From the American Cancer society the stuff is so potent that they warn "even on your skin"
If you lack dihydropyrimidine dehydrogenase (DPD deficiency). DPD is an enzyme the body uses to process this drug.
This inborn genetic abnormality can cause extreme side effects if you use 5-FU (even on your skin) or capecitabine.
- They FDA really went out of their way here.
- pay attention to the "and death" part, yet they don't deem it necessary to pretest, you just try your LUCK.
The FDA has announced revisions to the safety labeling for topical fluorouracil cream, Efudex
(Valeant Pharmaceuticals International), to reflect its contraindication in patients with dihydropyrimidine
dehydrogenase (DPD) enzyme deficiency. Dihydropyrimidine dehydrogenase is the initial and rate-limiting
enzyme of 5-fluorouracil (5-FU) catabolism.
These toxicities include stomatitis, mucositis, diarrhea, myelosuppression, neurotoxicity and death. (This is the cream warning not injection.)
- Seems the poison Control center of NY are aware of this danger and on its toxic list.
But when I arrived at the NY Presbyterian Hospital Emergency Room, on E68th in NYC they have never heard of the DPD.
- This cancer center out of Canada highlights the risks the cream poses to the
reproductive system. This is for none DPD deficient patients, so imagine the damage
for a DPD deficient patient.
• Fluorouracil cream may damage sperm and may harm the baby if used during pregnancy. It is best to use birth control while being treated with fluorouracil. Tell your doctor right away if you or your partner becomes pregnant. Do not breast feed during treatment.
- The number of deaths posted on these next two links are stunning and surprised it has not raised the FDA's eyebrows.
- If you don't die you will be tortured for months to come.
- More sad stories! I must have found 100s of these online while searching, yet the FDA is not touching this issue.
- I guess its rare.
- Valuable info and another family break up for no reason due to ignorance in the medical field. Whos to blame?
Last Updated (Wednesday, 16 April 2014 06:43)