Mandated by the FDA, Bristol-Myers Squibb has released a Medication Guide for Coumadin® (warfarin) as well as reorganized safety information on the Coumadin® label. The FDA “requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern.”  Notification of the new Medication Guide was announced by FDA Medwatch on October 6, 20006.

Coumadin is used to reduce the risk of blood clots forming in the body.  Cancer patients are at higher risk for blood clots, and both chemotherapy and implanted devices to access veins such as Port-a-Cath® increase the potential danger.  However, Coumadin can cause bleeding problems itself or in combination with other drugs or foods and needs to be carefully monitored.

Among information included in the Coumadin Medications Guide:

• Take your Coumadin exactly as prescribed.
• Get regular blood tests (PT/INR) to test your response to Coumadin.  The PT/INR tests checks how fast blood clots, and your dose of Coumadin will be adjusted to keep the PT/INR in the range best for you.
• Call your healthcare provider right ways if you get any of the following signs or symptoms of bleeding problems such as pain, swelling, or discomfort; headaches, dizziness, or weakness, or unusual bruising.  Other symptoms of bleeding problems include nosebleeds, bleeding gums, cuts that take a long time to heal, heavy menstrual bleeding, pink or brown urine.  Red or black stools, coughing up blood, or vomiting blood or material that looks like coffee grounds are also symptoms that should be reported immediately to a health care provider.
• Avoid sports and other situations that could result in an injury.

Other medicines, including prescriptions and over-the-counter drugs, vitamins, and herbal supplements can interact with Coumadin and either increase the dose you need or increase its side effects.

• Tell your doctor about all prescription and non-prescription drugs, vitamins, herbal supplements that you are taking and don’t start taking another drug without telling the doctor.
• Don’t stop taking any medication, vitamin, or supplement without first discussing it with your doctor.
• Keep a list of medicines with you at all times to show your health care providers and pharmacist.
• Do not take other medicines that contain warfarin, the active ingredient in Coumadin.
• Wear or carry information that you take Coumadin, and tell all your healthcare providers that you are taking it.

Certain foods can interact with Coumadin.  Patients taking the drug should avoid:

• Drinking alcohol.
• Drinking cranberry juice or eating cranberry products.
• Making diet changes while on Coumadin without talking them over with your doctor.
• Eating large amounts of leafy green vegetables, which contain vitamin K and can reduce the effect of Coumadin.  Some vegetable oils are also high in vitamin K.

The Wellness Community of Central New Jersey is sponsoring a special workshop for people affected by colorectal cancer on Thursday, October 12, 2006.  Dr. Daniel Joseph Moriarty, Medical Director of the Overlook Hospital Cancer Center, and Kristen Scarlett, a Licensed Professional Social Worker at Overbrook will provide information on the latest treatments for colon and rectal cancer.  In addition, those attending will learn effective strategies for managing side effects of treatment and how to live well with the disease and beyond it.  Dinner is included, as well.

• Frankly Speaking About New Discoveries in Cancer:  Special Focus on Colorectal Cancer
• A free workshop for people affected by colorectal cancer
• Thursday, October 12, 2006
• 5:30 pm:  registration and dinner
• 6:00 pm:  program begins
• The Inn at Somerset Hills
• 80 Allen Road
• Basking Ridge, NJ 07920
• To register call: 908–658– 5400

The program is a collaborative effort of the Wellness Community of Central New Jersey and Overlook Hospital.

Researchers in Italy analyzed information from a large group of people with colon or rectal cancer in Switzerland and Italy, matched to a control group without cancer.  One portion of fried food weekly did not increase the risk for colorectal cancer.

Analyzing the types of oil used for frying, they found a small (10%) protective effect of using olive oil for frying, but no difference in risk from other oils.

C. Galeone and colleagues, writing in the October 3, 2006 issue of Annals of Oncology concluded:

Our results do not indicate a relevant role of fried foods on colorectal cancer risk. We found a possible favorable effect of (fried) olive oil on colon cancer risk but not on rectal cancer risk.

Patients treated with fluorouracil (5FU) can develop painful mouth sores that make eating, drinking, and swallowing difficult.  Mouth sores (mucositis) are a complication for about 40% of patients who receive bolus 5FU chemotherapy.

Researchers in Denmark compared chlorhexidine mouthwash to mouth cooling with ice chips to a placebo mouth rinse to prevent mouth sores.  In research reported at the European Society for Medical Oncology (ESMO), they found that either cooling the mouth or using the chlorhexidine mouthwash significantly reduced the length and severity of mucositis.

Over 200 patients who were being treated with intravenous bolus injections of 5FU five days a week every four weeks (Mayo Clinic regimen) were randomized to receive preventively:

• 15 ml of 0.1% chlorhexidine mouthwash swished in the mouth for one minute three times a day for three weeks
• cryotherapy with ice chips chewed beginning 10 minutes before chemotherapy began through 35 minutes afterwards
• a placebo of normal saline mouthwash with an additive to taste like the chlorhexidine solution

Results showed that

• In the placebo group 33% of patients had mouth sores or ulcers severe enough to impair eating or require artificial nutrition.  Sores lasted a median of 5 days.
• 13% of the patients using the mouthwash had similarly severe sores that lasted a median 3 days.
• 11% of ice chip users had severe sores that lasted a median 1 day.
• About 40% of patients in all three groups had milder grade 1 or 2 sores.

Dr. Jens Benn Sorensen and his colleagues from the Department of Oncology at the National University Hospital in Copenhagen conducted the double-blind, placebo-controlled study.

Dr. Sorensen noted that previous studies with both mouthwash and ice chips had been inconsistent, so the team was careful to standardize the dose and timing treatments for all patients in the study, as well as include a placebo group and test the intervention with a single chemotherapy regimen.

Although ice chips are cheap and simple to use, but they cannot be used with infusional 5FU regimens, when oxaliplatin is part of the regimen, or with chemotherapy drugs that have longer half-lives than fluorouracil.  However, chlorhexidine mouthwash doesn’t have these drawbacks.

In a news release from ESMO, Dr. Sorensen said,

The current study is the first double-blind randomized evaluation of chlorhexidine in a large patient population treated homogeneously with one single chemotherapy regimen of highly mucositis inducing potential. The results point towards a role for chlorhexidine in prevention of oral mucositis in adult patients with solid tumors treated with chemotherapy in conventional doses, without having the disadvantage of being restricted to use with chemotherapy agents with a short half-life such as is the case for cryotherapy.

Amgen has announced that is is offering comprehensive financial assistance to help patients use its cancer medicines. The program includes a cap on out-of-pocket payments for patients receiving Vectibix™, the newly FDA-approved Amgen treatment for metastatic colon and rectal cancer.  The Amgen Oncology Assistance program will be available for uninsured, underinsured, and patients who are unable to afford co-payments for Amgen oncology drugs.  Assistance will be provided through the Amgen SAFETY NET® Foundation.

The Amgen Oncology Assistance program includes:

• Vectibix Cap:  patients, regardless of insurance or income, will be eligible for SAFETY NET assistance once their co-payments for Vectibix (panitumumab) reach 5% of their gross income.
• Uninsured or underinsured patients with gross incomes under $75,000 can receive Amgen oncology medicines at no cost through SAFETY NET.
• Financial assistance for low income or uninsured patients is also available through independent, third-party patient assistance programs who receive charitable donations from Amgen to help patients with the cost of treatment.

Patients or their doctors can contact the SAFETY NET program through Amgen’s Reimbursement Connection online or by calling 1–800–272–9376. 

The Reimbursement Connection can also help physicians and oncology office staff with insurance reimbursement questions, coding, preauthorization support, and insurance appeals information, as well as assisting them and their patients in locating payment resources.