Older Women with Diabetes Face Higher Risk for Colon Cancer

(BUSINESS WIRE)--A research team led by Mayo Clinic physicians has found that older women with diabetes face a more than doubled risk for some types of colorectal cancer. The findings are being presented at Digestive Disease Week 2010, the annual meeting of the American Gastroenterological Association.

Colorectal cancer (http://www.mayoclinic.org/colon-cancer/) remains the third-leading cause of cancer deaths among women in the United States. Diabetes has been identified as a colon cancer risk factor, but the mechanisms aren’t completely understood. For this population-based cohort study, researchers examined data from 37,695 participants of the Iowa Women’s Health Study (IWHS), which enrolled women ages 55–69 in 1986 and remains ongoing. Of these women, 2,361 reported a diagnosis of Type 2 diabetes and 1,200 developed colorectal cancer.

To find the links between colorectal cancer and diabetes, the researchers worked with regional pathology laboratories to obtain tumor tissue samples from IWHS participants who were diagnosed with colorectal cancer. They linked the tissue samples with other IWHS data, looking for cancer pathways and risk factors, and whether those risk factors were associated with three different molecular markers: microsatellite instability (MSI), CpG island methylation (CIMP), and BRAF gene mutations.

“Diabetes was more strongly associated with the MSI-high, CIMP-positive and BRAF-mutation cancer subtypes in this group of older women,” says Mayo Clinic gastroenterologist Paul Limburg, M.D. (http://www.mayoclinic.org/bio/10658084.htm). Dr. Limburg explains that diabetes appeared to confer a greater than twofold increase in risk for these molecularly-defined tumors, compared to women without diabetes.

“Knowing that diabetic women have these findings should help to facilitate more appropriate colorectal cancer prevention and treatment options,” says Anthony Razzak, M.D., a Mayo Clinic research fellow and presenter at the conference. “Our findings may lead to new strategies for colon cancer screening, chemotherapy and chemoprevention in women with diabetes.”

“From a research perspective, this information allows us to clarify how environmental exposures and other risk factors might effect tumor formation at a molecular level,” says Dr. Razzak. For future projects, the researchers will work to understand more about the biology of colorectal cancer and how it is influenced by diabetes, as well as other chronic conditions and exposures. They hope to use that information to improve patient care.

“Unfortunately, diabetes and colon cancer are both very common in the United States, so making links between these disorders has substantial public health implications,” says Dr. Limburg.

Mayo Clinic’s Division of Gastroenterology and Hepatology (http://www.mayoclinic.org/gi-rst) has been ranked No. 1 in the U.S. News & World Report Honor Roll of Top Hospitals since the rankings began 20 years ago.

Collaboration

The study was funded by the National Cancer Institute. Additional Mayo Clinic co-authors are Amy Oxtenko, M.D.; Robert Vierkant; Lori Tillmans; Alice Wang; Susan Slager, Ph.D; Thomas Smyrk, M.D.; Stephen Thibodeau, Ph.D.; and James Cerhan, M.D., Ph.D. Co-authors from other institutions are Daniel Weisenberger, Ph.D., and Peter Laird, Ph.D., both of the University of Southern California Epigenome Center; Charles Lynch, M.D., Ph.D., University of Iowa College of Public Health, Iowa City; Kristin Anderson, Ph.D., and Lisa Harnack, Ph.D., both of the University of Minnesota Cancer Center, Minneapolis; Robert Haile, Ph.D., of the University of Southern California School of Medicine, Los Angeles; and John Potter, M.D., Fred Hutchinson Cancer Research Center, Seattle.

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FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely

The Food and Drug Administration issued a final rule today that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs.

Products covered by the FDA action include acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen. Acetaminophen is in a class by itself. The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers.

“Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches, “ said Charles Ganley, M.D., director, FDA’s Office of Nonprescription Drugs in the Center for Drug Evaluation and Research. “However, the risks associated with their use, need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk.”

Under the final rule, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

Since 2006, some manufacturers have voluntarily revised their product labeling to identify these potential safety concerns. However, the voluntary changes to labeling do not address all of the labeling requirements in the new rule. For example, the new rule includes a warning on products containing acetaminophen that instructs consumers to ask a doctor before they are taking the blood thinning drug warfarin. The new rule requires all manufacturers to relabel their products within one year of today’s date.

Safety data reported in medical literature indicate that people sometimes take more acetaminophen than the labeling recommends. Others unknowingly take multiple products containing acetaminophen at the same time. Exceeding the recommended dosage of acetaminophen may increase the risks for severe liver damage. Alcohol use can also increase the risk of liver damage with acetaminophen.

The risk for stomach bleeding may increase in people who use NSAIDs and who are taking blood-thinning drugs (anticoagulants) or steroids. Stomach bleeding risks also increase for people who take multiple NSAIDs at the same time, or in people who take them longer than directed. Alcohol use can increase the risk for stomach bleeding with NSAIDs use.

An FDA Advisory Committee meeting will be convened on June 29 & 30, 2009, to discuss further steps the FDA could take to reduce the risk of liver damage associated with acetaminophen overdoses.

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