Problem with FD&C Blue Dye #1?

SUMMARY OF REPORTS

• As of September, 2003, the FDA is aware of 20 cases from the scientific literature or in FDA post-marketing adverse event reports associating the use of blue dye in tube feedings with blue discoloration of body fluids and skin, as well as more serious complications. There have been 12 reported deaths and one case with an unknown outcome.
• In more than 75% of all reported cases, patients had a reported history of sepsis (and therefore likely altered gut permeability) before or during systemic absorption of Blue 1.
• Time of onset of toxicity from first use of Blue 1 varied from several hours to 20 days of continuous use in enteral feedings.

At this time, the FDA believes practitioners should be aware of the following points:

• Use of Blue 1-tinted enteral feedings for detecting aspiration has been associated with several serious adverse events, including death, although a direct causal relationship has not been definitely established.
• The safety of Blue 1-tinted enteral feedings for detecting aspiration has not been documented.
• Based on the reports received to date, patients at risk for increased intestinal permeability, which includes those with sepsis, burns, trauma, shock, surgical interventions, renal failure, celiac sprue, or inflammatory bowel disease, appear to be at increased risk of absorbing Blue 1 from tinted enteral feedings.
• In addition to the possibility of systemic toxicity, Blue 1-tinted enteral feedings may interfere with diagnostic stool examinations, such as the hemoccult test.
• Other blue dyes, such as methylene blue and FD&C Blue No. 2, may have similar if not greater toxicity potential than Blue 1 and would not be appropriate replacements.

Leaky Gut/Intestinal Permability -- Hows, Whys, Stages

Hows and Whys of "Leaky Gut" The purpose of the gastro-intestinal (GI) tract, or gut, is multi-fold. Basically, it: i) Digests foods. ii) Absorbs small food particles to be converted into energy. iii) Carries nutrients like vitamins and minerals attached to carrier proteins across the gut lining into the bloodstream. iv) Contains a major part of the chemical detoxification system of the body, and v) Contains immunoglobulins or antibodies that act as the first line of defence against infection. Leaky gut syndrome (LGS) is a poorly recognised but extremely common problem. It is rarely tested for. Essentially, it represents a hyper-permeable intestinal lining. In other words, spaces develop between the cells of the gut wall, and bacteria, toxins and food leak through. The official definition is an increase in permeability of the intestinal mucosa to luminal macromolecules, antigens and toxins associated with inflammatory degenerative and/or atrophic mucosal damage. The Mucosal Barrier The barrier posed by the intestinal mucosa is, even in normal subjects, an incomplete one. Small quantities of molecules of different sizes and characteristics cross the intact epithelium by both active and passive mechanisms. The route by which such transfer occurs is, at least in part, dependent on molecular size. Molecules up to about 5000 Daltons in size cross the epithelial membrane of the microvilli. Larger molecules may utilise an intercellular pathway or depend on being taken up by endocytosis entering the cell at the base of the microvilli. How Does The Gut Become Leaky? Once the gut lining becomes inflamed or damaged, this disrupts the functioning of the system. The spaces open up and allow large food antigens, for example, to be absorbed into the body. Normally the body sees only tiny food antigens. When it sees these new, larger ones, they are foreign to the body's defence system. So the attack results in the production of antibodies against once harmless, innocuous foods. Isn't Leakier Better? It might sound good that the gut can become leaky, because it would seem that the body would be better able to absorb more amino acids, essential fatty acids, minerals and vitamins. For the body to absorb a mineral it does not just slowly diffuse across the gut membrane it must be attached to a carrier protein. This protein hooks onto the mineral and actually carries it across the gut wall into the bloodstream. However, when the intestinal lining is damaged through inflammation these carrier proteins get damaged as well, so now the victim is vulnerable to developing mineral and vitamin deficiencies. The 7 stages of the 'inflamed’ gut. 1 . When the gut is inflamed, it does not absorb nutrients and foods properly and so fatigue and bloating can occur. 2. As mentioned previously, when large food particles are absorbed there is the creation of food allergies and new symptoms. 3. When the gut is inflamed the carrier proteins are damaged so nutrient deficiencies can occur. 4. Likewise when the detoxification pathways that line the gut are compromised, chemical sensitivity can arise. Furthermore the leakage of toxins overburdens the liver so that the body is less able to handle everyday chemicals. 5. When the gut lining is inflamed the protective coating of lgA (immunoglobulin A) is adversely affected and the body is not able to ward off protozoa, bacteria, viruses and yeasts. 6. When the intestinal lining is inflamed, bacteria and yeasts are able to trans-locate. This means that they are able to pass from the gut lumen or cavity, into the bloodstream and set up infection anywhere else in the body. 7. The worst symptom is the formation of antibodies. Sometimes these leak across and look similar to antigens on our own tissues. Consequently, when an antibody is made to attack it, it also attacks our tissue. This is probably how autoimmune disease start.

Leaky Gut Syndrome - also known as Intestinal Permeability

What is Leaky Gut Syndrome? Leaky Gut Syndrome (intestinal permeability) is not a disease but rather an intestinal dysfunction that underlies many different illnesses and symptoms. However, Leaky gut syndrome is actually poorly recognized but yet an extremely common problem. What causes Leaky Gut Syndrome? Leaky gut syndrome results in an increase in the so-called permeability of the mucosal intestinal lining to luminal macro molecules. In other words, large spaces develop between the cells of the gut wall and this allows bacteria, toxins and food to leak in. What happens next with Leaky Gut Syndrome? Once the lining of the digestive tract becomes inflamed or damaged it disrupts the way the digestive system functions. The spaces that open up allow large food antigens to be absorbed into the body, which are regarded as 'foreign' to the body's defense system. This results in the production of antibodies against what was once harmless and innocuous foods. This is how food allergies are created as well as new symptoms with target organs. e.g. arthritis and fibromyalgia. Symptoms of the Inflamed Gut associated with Leaky Gut Syndrome * It does not absorb nutrients and foods properly so it may result in fatigue and bloating. * When the detoxification pathways that line the gut are compromised, chemical sensitivity may also occur. * The leaking of toxins also burdens the liver so that the body is less able to handle everyday chemicals. * Carrier proteins are also damaged so nutrient deficiencies occur which cause a variety of symptoms: o Magnesium deficiency causes muscle spasms and fibromyalgia o Copper deficiency leads to high cholesterol and Osteoarthritis o Zinc deficiency leads to malabsorption which causes hair loss and some eye disorders (macular degeneration) Inflamed Gut Lining because of Leaky Gut Syndrome When the gut lining is inflamed the protective coating of lgA (immunoglobulin A) is negatively affected. The body is unable to ward off bacteria, viruses and parasites as well as fungus and yeasts like Candida. These pathogenic bad organisms then pass from the gut cavity into the bloodstream and set up infection anywhere else in the body. Formation of Antibodies with Leaky Gut Syndrome Formation of antibodies may occur. They leak across and look similar to antigens on our own tissues. So when an antibody is made to attack it, it also attacks the tissue. This is possibly how auto-immune and chronic disease like Crohn's Disease, Rheumatoid arthritis, Lupus, Multiple Sclerosis, and Thyroiditis start. Formation of Toxins with Leaky Gut Syndrome Together these conditions encourage the formation of toxins. These toxins can also cause leaks. When food particles escape through the leaks into the blood stream, the immune system senses them as a threat (an antigen), and results in food sensitivities. Avoid Unhealthy Food if you have Leaky Gut Syndrome Poor food choices not only cause Leaky Gut Syndrome but may lead to food sensitivities as well. Processed foods are low in nutrients and fiber and often contain lots of food additives, unhealthy fats and sugar. This creates an alkaline intestinal pH and a slow waste transit time. Leaky Gut Syndrome may cause confusion, memory loss, and 'brain fog' In addition to the creation of food allergies, the bloodstream is flooded by bacteria, fungi and parasites that, in the healthy state, would not be able to penetrate the protective barrier of the gut. These microbes and their toxins, if present in large enough amounts, can overwhelm the liver's ability to detoxify. This results in symptoms such as confusion, memory loss, and 'brain fog'. The following may lead to Leaky Gut Syndrome (Intestinal Permeability): * Antibiotics - because they lead to the overgrowth of abnormal flora in the gastrointestinal tract (bacteria, parasites, candida, fungi) * Alcohol and caffeine (strong gut irritants) * Foods and beverages contaminated by parasites like Giardia lamblia, cryptosporidium, blastocystis hominis and others * Foods and beverages contaminated by bacteria like helicobacter pylori, klebsiella, citrobacter, pseudomonas and others * Chemicals in fermented and processed food (dyes, preservatives, peroxidized fats) * Enzyme deficiencies (e.g. celiac disease, lactase deficiency causing lactose intolerance) * NSAIDS (non-steroidal anti-inflammatory drugs) like ASA, ibuprofen, indomethacin, etc. * Prescription corticosteroids (e.g. prednisone, hydrocortisone, DepoMedrol, etc.) * High refined carbohydrate diet (e.g. candy bars, cookies, cake, soft drinks, white bread) * Prescription hormones like the birth control pill * Mold and fungal mycotoxins in stored grains, fruit and refined carbohydrates * Dysbiosis and gastrointestinal Disease * Chemo-therapy and radiation therapy causing immune overload Suggestions for Leaky Gut Syndrome Great Smokies Intestinal Permeability Test will assist in making an accurate evaluation of leaky gut syndrome. Microbiology evaluation will test for overgrowth of fungus, bacteria and parasites. Digestive aids like probiotics, digestive enzymes, natural herbal anti inflammatories and anti candida supplements assist in restoring the integrity of the mucosal lining of the digestive tract. Read more on Leaky Gut Syndrome (Intestinal Permeability) here.