FDA to Review Cancer Reports Related to Crohn's Drugs

Source: (Reuters Health)
By Lisa Richwine

WASHINGTON (Reuters) - U.S. health officials are investigating whether drugs for rheumatoid arthritis and Crohn's disease are linked to cancers in children and young adults, the Food and Drug Administration said on Wednesday.

The prescription drugs, members of a family called TNF blockers, include Johnson & Johnson's Remicade, Abbott Laboratories Inc's Humira, and Amgen Inc and Wyeth's Enbrel.

The FDA said it was probing about 30 reports of cancer in children and young adults treated with TNF blockers plus other immune-suppressing medicines between 1998 and April 29, 2008. About half of the cancers were lymphomas.

A fourth TNF blocker, UCB's Cimzia, won FDA approval on April 22, 2008.

The prescribing information for all four drugs already warns about a possible risk of cancer.

Still, "the reports of these events in children and young adults receiving TNF blockers are of concern and deserve further investigation," an FDA statement said.

The agency said it currently believed potential benefits outweighed the risks for certain young people with diseases the drugs are approved to treat.

The FDA said it asked the makers of Remicade, Enbrel and Humira for information on all cases of cancer reported in children and young adults treated with the drugs. UCB is planning a study of long-term risks of Cimzia, including cancer. That study is expected to start next year and take about 10 years to finish, the FDA said.

Amgen estimates that fewer than half of the 30 cases cited by the FDA were reported in Enbrel patients, company spokeswoman Sonia Fiorenza said. Enbrel was the first of the drugs approved, winning clearance in 1998.

Amgen and Wyeth support the FDA review and will provide any requested information, Fiorenza said.

For Remicade, the vast majority of patients who developed cancer were being treated for the bowel disorder Crohn's disease, and all but one also were given other immune-suppressing drugs that are suspected to carry a cancer risk, said Brian Kenney, a spokesman for J&J's Centocor unit.

Kenney said he could not provide the specific number of cancer cases reported for Remicade. Schering-Plough Corp sells Remicade outside the United States.

Abbott has not seen any cases of lymphoma or other cancers in children given Humira in clinical trials, company spokeswoman Raquel Powers said. The company is working with the FDA to evaluate all available data, she added.

UCB's Cimzia is not approved for children, company spokeswoman Antje Witte said.

The injectable drugs suppress the immune system by blocking the activity of TNF, a chemical that can cause inflammation.

Each is approved to treat one or more immune system diseases including rheumatoid arthritis, plaque psoriasis and Crohn's disease.

Cancers were reported in patients treated with the drugs for juvenile idiopathic arthritis, which the FDA said was a new name for juvenile rheumatoid arthritis, as well as Crohn's and other conditions.

The FDA said it would announce findings of its review and any recommendations within about six months.

Long-term studies are needed, however, to provide definitive answers as cancers take a long time to develop, the FDA said.

Beat Inflammatory Bowel Disease

A Cleveland Clinic study found that fish oil, soluble fiber and antioxidants helped treat patients with ulcerative colitis and reduced their need for steroid therapy. Patients who took the supplements, which have fewer side effects and are safer than many of the colitis drugs on the market, were less likely to start treatment with the drugs.

The study involved patients aged 18 and older who suffered from mild to moderate active ulcerative colitis. Those who were on corticosteroid therapy and were given the nutritional supplement needed significantly lower doses of the drugs to control their symptoms than those given a placebo.

Ulcerative colitis, an inflammatory bowel disease that typically affects those between the ages of 15 and 40, can cause abdominal cramps, bloody diarrhea and fever. Drugs like corticosteroids are used to control inflammation in the disease, but, while they're highly effective, long-term use often leads to:

• Insomnia
• Mood alterations
• Increased appetite
• Hypertension
• Osteoporosis
• Other negative side-effects

The side effects are often so severe that many patients stop using the drugs all together. However, over 25 percent of patients who stop their use have a relapse of symptoms.

While the nutritional supplement in the current study combined fish oil, soluble fiber and antioxidants, previous studies have shown that fish oil alone is also able to reduce the need for corticosteroids in colitis patients.

Researchers believe that a nutritional supplement like SEROVERA® AMP 500 may help to diminish inflammation and provide nutrition in colitis patients, and suggest physicians add this combination of ingredients to their ulcerative colitis therapy regimens.

Crohn's Disease through Milk?

Researchers believe that Crohn’s disease, a bowel disorder that causes inflammation of the intestine leading to diarrhea, pain, weight loss and fatigue, may be caused by a type of bacteria that is passed to humans through milk.

The bacteria, mycobacterium avium paratuberculosis (MAP), was found in some 92 percent of patients with Crohn’s disease, compared to only 26 percent of patients in a control group. MAP is present in about two percent of commercial pasteurized milk.

As a solution, researchers recommend that people with Crohn’s disease, or those who feel at risk, drink UHT milk, which is pasteurized at higher temperatures that likely kill MAP.

The bacteria may also be associated with irritable bowel syndrome (IBS), according to researchers.

Journal Clinical Microbiology July 2003l;41(7):2915-23

Foods and Supplements That Can Worsen Diarrhea

If you suffer from Colitis, Ulcerative Colitis, Crohn’s and have chronic diarrhea the followings foods and supplements may contribute to loose stools.

• Dried beans, corn, vegetables and cabbage family vegetables are all high in fiber, which may worsen diarrhea
  
• Fruits and juices contain fructose, which can worsen diarrhea
• Caffeine-containing beverages such as coffee and tea can have a laxative effect
• Alcoholic beverages such as beer, wine and liquor can worsen diarrhea
• Fatty meats such as bacon, lunch meats, and heavily marbled meats can worsen diarrhea
• Fried foods, pastries and chips are high in fat which can worsen diarrhea
• NutraSweet may be a problem for some people
• Large quantities of nuts or nut butters may worsen symptoms
• Concentrated sweets can worsen symptoms
• Dried fruits such as figs, dates, raisins and prunes can have a laxative effect
• Prune juice can exert a laxative effect
• Sugar-free gums and mints contain the sugar alcohols sorbitol, mannitol, and/or xylitol, which can have a laxative effect
• Real black licorice (not the candy) can have a laxative effect

In addition to food choices that may be bother some there are several supplement which may cause more frequent bowel movements and exacerbate existing diarrhea.

Supplements that can Worsen Symptoms

• 5-HTP
• Acetyl L-carnitine
• Activated charcoal
• Bee pollen
• Borage oil
• Bovine colostrum
• Cayenne
• Chlorophyll
• Chondroitin sulfate
• DHA
• EPA
• Flaxseed oil
• Glucosamine
• Guarana
• Guar gum
• Horse Chestnut seed
• Kola Nut
• Lactulose
• Mate
• Senna

Stay ahead of your diarrhea by staying well hydrated and well informed.

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Possible Causes of IBS and Diagnosis

The most common symptoms of IBS include periodic bouts of abdominal pain accompanied by diarrhea, constipation, or both. Flatulence, belching, and bloating may also occur. The episodes may subside with a bowel movement. However, IBS patients may pass only a small amount of stool that may or may not contain mucus, and they may continue to feel an urgent need to defecate. IBS is often divided into two major variants:

1. Diarrhea-predominant IBS: three to seven bowel movements per day; loose, watery stools; and fecal urgency. One or more of these symptoms must be present.


2. Constipation-predominant IBS: fewer than three bowel movements per week; hard or lumpy stools; and straining during bowel movements. One of more of these symptoms must be present.

People with IBS appear to have hypersensitive nerves within the large intestine. Under certain conditions (such as stress or consumption of certain foods), the normal passage of stool and gas may cause pain. Research has suggested that IBS patients have extra sensitive pain receptors in the gastrointestinal tract, which may be related to an abnormal level of serotonin, a neurotransmitter involved in regulating digestion and mood. Their level of serotonin may help explain why people with IBS are likely to be anxious or depressed (Kasper DL et al 2005).

Other significant factors implicated in IBS include recent infection within the gastrointestinal (GI) tract, which can disturb the digestive flora necessary to help break down remaining nutrients in the colon (De Schryver AM et al 2000; Talley NJ et al 2002). Research has shown that in rare cases, IBS has developed following salmonella or Campylobacter pylori infections.

The diagnosis of IBS is a diagnosis of exclusion, meaning that all other possible diseases must be ruled out before a physician arrives at the diagnosis of IBS. Typically, the diagnosis begins with a medical history, including questions about the duration, severity, and characteristics of symptoms. The physician will ask about diet, stress, any medications currently being taken, and changes in bowel function. Most people with IBS have mild symptoms.

Laboratory tests, including complete blood count, thyroid function, erythrocyte sedimentation rate, and urinalysis, may be done to rule out other potential causes. Depending on symptoms, additional testing may include a lactose tolerance test and a check for the presence of blood, bacteria, and parasites in feces (NIDDK 2006).

The colon may be examined with flexible sigmoidoscopy or colonoscopy (procedure used to see inside the colon and rectum to screen for colon cancer as well) . If indicated, a biopsy from the colon can be performed. A colonoscopy is indicated when an individual is anemic or has lost weight or if polyps are found. However, in IBS the large intestine appears normal (NIDDK 2006; Lindor KD et al 2005).

A diagnosis of IBS may be made if patients have had abdominal pain or discomfort for at least 12 weeks, not necessarily consecutively, during the past year and if:

• The onset of pain corresponds to a change in the regularity of bowel movements


• The passage of stool relieves the pain


• The onset of pain corresponds to a change in the appearance of stool

Dietary recommendations include:

L-glutamine. L-glutamine is the most common amino acid in the blood and is important in maintaining strength and boosting the immune system. Under normal circumstances, dietary intake and production of L-glutamine are sufficient. However, in times of stress or increased energy output, tissues need more L-glutamine than usual. A lack can lead to improper absorption of nutrients and a depressed immune system (Roth E et al 1996; van der Hulst RR et al 1996). Nutrition and intestinal function are intimately related; consequently, chronic GI diseases such as IBS often result in malnutrition. Glutamine has protective and reparative effects on the colon and bowel (Ziegler TR et al 2000).

Aloe mucilaginous polysaccharides (AMP). Aloe mucilaginous polysaccharides are long chain sugar molecules composed of individual mannose and glucose sugar molecules connected together. The AMP molecule is but one of the approximate 200 ingredients found in the Aloe vera plant. However, the mucilaginous polysaccharide is the sole ingredient responsible for all the healing properties attributed to Aloe. Reduces inflammation which is involved in such diseases as ulcerative colitis, IBS and other gastrointestinal disorders.