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X. Nerusul, M.S., Ph.D.

Co-Director, New York Medical College

These 2 adverse Antihistamines Page 29 of 72 Final Report Update 2 Drug Effectiveness Review Project events necessitated participant withdrawal from study. Three observational studies143, 152, 153 presented data on adverse events but were of poor quality (Appendix F). Minor neurologic and respiratory symptoms were the most common adverse events, particularly headache, insomnia, nervousness, somnolence, and upper respiratory tract infections with oral antihistamines. Rates varied widely, however, and adverse events were also very common among placebo groups. Three placebo-controlled trials112, 114, 151 reported somnolence in <2% to 10% of patients treated with cetirizine compared with <2% patients treated with placebo. Upper respiratory tract infections were observed in 3 trials145, 146, 151 with no significant difference between active treatment and placebo (Evidence Tables 20, 9, and 22 respectively). One trial evaluating azelastine nasal spray found increased incidence of pharyngitis (7. One head-to-head study examined the effects of terfenadine, astemizole, loratadine, and cetirizine on electrocardiogram among children with perennial allergic rhinitis. Study participants were treated for 18 months and adverse events were assessed at the end of treatment. Although this study did not meet inclusion criteria for this report with respect to population characteristics (the study did not involve allergic rhinitis or urticaria), it was included in this paper because it provided long-term data on the safety of cetirizine in a large population of young children. Serious adverse events attributed to the study medication occurred in 1 child receiving cetirizine and 5 children receiving placebo. There were 10 accidental overdoses of study medications by study participants; 2 of these participants were receiving cetirizine. Symptoms and events (Evidence Table 22) were reported with similar frequency in cetirizine- and placebotreated groups. Age-appropriate increases in height and weight were observed during the study period. Antihistamines Page 30 of 72 Final Report Update 2 Drug Effectiveness Review Project Key Question 3. Are there subgroups of patients based on demographics (age, racial groups, gender), concomitant medications (drug-drug interactions), comorbidities (drug-disease interactions or pregnancy), for which one newer antihistamine is more effective or associated with fewer harms? Patients with allergic rhinitis with mild intermittent asthma or atopic dermatitis tolerated newer antihistamines similar to patients without these comorbidities. There was minimal increased risk of birth defects observed with H-1 receptor antagonists including cetirizine, fexofenadine, and loratadine. Detailed assessment Age, gender, race/ethnicity No direct evidence was available to determine whether any antihistamine has an advantage in efficacy or harms for any gender or racial group. Asthma Three fair-quality placebo-controlled trials were identified in patients with allergic rhinitis and asthma (Evidence table 24). Berger and colleagues139 examined desloratadine in patients with seasonal allergic rhinitis and asthma and found a significant decrease in total asthma symptom scores in the treatment group. There were no significantly different adverse events reported in primarily adult patients with allergic rhinitis and asthma compared with patients without asthma. There were no reports of worsening asthma with active treatment; only 2 placebo-treated patients146 reported asthma aggravated. Most patients included in these studies had mild intermittent asthma and were likely not using inhaled corticosteroids. Two trials evaluated cetirizine,159, 160 levocetirizine (Evidence Table 3),68, 146 and azelastine nasal spray (Evidence Table 1). Nasal burning, bitter taste or altered taste, and epistaxis were observed more often in azelastine-treated patients than with placebo. Atopic dermatitis An 18-month, placebo-controlled trial studied levocetirizine in 510 children 12 to 24 months in age who had atopic dermatitis, allergy to grass pollen or house dust mites, and family history of allergies. Antihistamines Page 31 of 72 Final Report Update 2 Drug Effectiveness Review Project About 96% of enrolled children reported at least 1 adverse event during the trial. The most commonly reported event was upper respiratory tract infections (levocetirizine, ~51% compared with placebo, ~50%). Worsening atopic dermatitis was low and occurred similarly between groups (levocetirizine, ~5% compared with placebo, ~6%).

States are increasingly using the criteria defined in Caring for Our Children and the Managing Infectious Diseases in Child Care and Schools publications. Usually, the criteria in these two sources are more detailed than the state regulations so can be incorporated into the local written policies without conflicting with state law. If a child has been in a very hot environment and heatstroke is suspected, a higher temperature is more serious; d. Oral temperatures are difficult to take for children younger than four years of age; 145 Chapter 3: Health Promotion and Protection f. Rectal temperatures should be taken only by persons with specific health training in performing this procedure and permission given by parents/guardians, however this method is not generally practiced due to concerns about proper procedure and risk of accusations of sexual abuse; g. Axillary (armpit) temperatures are accurate only when the thermometer remains within the closed armpit for the time period recommended by the device; h. A facility should not deny admission to or send home a staff member or substitute with illness unless one or more of the following conditions exists: a. However, it is not practical to test all ill staff members to determine whether they have common cold viruses or influenza infection. Chickenpox, until all lesions have dried and crusted, which usually occurs by six days; c. Shingles, only if the lesions cannot be covered by clothing or a dressing until the lesions have crusted; d. Measles, until four days after onset of the rash (if the staff member or substitute has the capacity to develop an immune response following exposure); f. Stool samples need to be collected at least 48 hours after antibiotic treatment is complete. Other types of Salmonella do not require negative test results from stool cultures. Vomiting illness, two or more episodes of vomiting during the previous twenty-four hours, until vomiting resolves or is determined to result from noninfectious conditions; h. Hepatitis A virus, until one week after symptom onset or as directed by the health department; i. Pertussis, until after five days of appropriate antibiotic therapy or until 21 days after the onset of cough if the person is not treated with antibiotics; j. Tuberculosis, until noninfectious and cleared by a health department official or a primary care provider; l. Strep throat or other streptococcal infection, until twenty-four hours after initial antibiotic treatment and end of fever; m. Head lice, from the end of the day of discovery until after the first treatment; n. Haemophilus influenzae type b (Hib), prophylaxis, until cleared by the primary health care provider; p. This includes a respiratory illness in which the staff member is unable to consistently manage respiratory secretions using proper cough and sneeze etiquette. A fully immunized child with a contagious, infectious or communicable condition will likely not have an illness that is harmful to the child or others. Children attending child care frequently carry contagious organisms that do not limit their activity nor pose a threat to their contacts. Axillary (under the arm) temperatures are less accurate, but are a good option for infants and young children when the caregiver/teacher has not been trained to take a rectal temperature. Therefore, tympanic thermometers should not be used in children under four months of age, where fever detection is most important. Mercury thermometers can break and result in mercury toxicity that can lead to neurologic injury. Although not a hazard, temporal thermometers are not as accurate as digital thermometers (2). If rectal temperatures are taken, steps must be taken to ensure that all caregivers/teachers are trained properly in this procedure and the opportunity for abuse is negligible (for example, ensure that more than one adult present during procedure). Rectal temperatures should be taken only by persons with specific health training in performing this procedure and permission given by parents/guardians. Many state or local agencies operate facilities that collect used mercury thermometers. For more information on household hazardous waste collections in your area, call your State environmental protection agency or your local health department.

This problem became compounded by her diet, which included large amounts of tuna and sushi that she loved and ate regularly (and which exposed her to even more mercury), and loads of dairy and sugar. Mold, mercury, antibiotics, sugar, gluten, and dairy-these are all potential immune irritants. She had elevated levels of antibodies to gluten, which is a common cause of autoimmune disease and triggers significant intestinal inflammation. And her mercury level was extremely high in her urine after a provocation test (the only way to assess total body burden of metals). At the first visit, I simply put Isabel on an anti-inflammatory elimination diet to remove possible triggers of inflammation from food allergens. I gave her a multivitamin; vitamins D, B12, and folate; fish oil; and evening primrose oil, all of which are anti-inflammatory. But if there is a shimmer of a possibility that this approach works, that it can help patients recover from some of the most debilitating, devastating human diseases out there, are we not obligated to investigate further? This is the mission of the Institute for Functional Medicine, but it needs help because it has no funding from the usual sources: government and Big Pharma. Get checked for heavy metal toxicity- mercury and other metals can cause autoimmunity. Imbalances in your gut flora have been linked to a whole host of diseases including autoimmune disease. One of the best ways to get your gut back in balance is to give the bugs good food in the form of prebiotics. For decades, the advice from pretty much every doctor, nutritionist, professional society, and government agency had been to eat less fat to lose weight and prevent disease. It turns out that eating less fat results in more obesity, inflammation, and disease. Omega-3 fats have been extensively studied as a way of treating inflammatory and autoimmune disease. These studies show great benefits, including decreased disease activity and less of a need for anti-inflammatory drugs. I have used it effectively in combination with diet and other therapies in many of my autoimmune patients. It also involves an initial elimination phase of foods like grains, legumes, nightshades, dairy, eggs, coffee, alcohol, nuts and seeds, refined and processed sugars, oils, and food additives. Researchers in this study used a six-week elimination phase where participants eliminated grains, legumes, nightshades, dairy, eggs, coffee, alcohol, nuts and seeds, refined/processed sugars, oils, and food additives. They followed this with a five-week maintenance phase where no food group reintroduction was allowed. The other part involves adding in the good stuff-real, whole foods that nourish your body with every single bite. The 10-Day Detox Diet is naturally anti-inflammatory because it removes these foods that create harm and increases all of the wonderful anti-inflammatory nutrients your body needs using whole foods. You might experiment with a lowered intake of eggs or choose to eat the highest quality local eggs. I wrote Food as a roadmap, based on the best and latest science of what to eat, to dispel the confusion and contention that keeps you overweight, sick, and unhappy. I also encourage strength training to build muscle and reduce body fat composition. It is often the trigger that leads to the cascade of events that causes that final, fatal heart attack. But you must do something daily to switch out of the alarm response to maintain your health. I stayed up late working long shifts in the emergency room, ignoring the demands of my body to rest.

Always ask your provider if you have any questions or would like more information. These techniques are designed to keep her still without actually holding her down or frightening her. Many providers like to keep a child in the office for observation for about 15 or 20 minutes after getting vaccines, in the unlikely event of an allergic reaction or in case the child becomes dizzy or faints. If your baby has a moderate or severe cold or other illness, you might be asked to postpone vaccinations until he gets better. AftertheImmunizationVisit Sometimes a child will have a fever or a sore leg or arm (where the shot was given) after an immunization visit. You can give your child a non-aspirin pain reliever to reduce any pain or fever that might follow vaccinations. If your baby cries for 3 or more hours without quitting, if he seems limp or unresponsive, if he starts having seizures (convulsions), or if you are worried at all about how your baby looks or feels, call your provider right away. Serious reactions are uncommon, but your provider will know how to deal with them if they occur. Part Two the Immunization Office Visit 25 Once again, a severe allergic reaction to a vaccine is very unlikely, but if one were to occur, be ready to respond to it: - If an allergic reaction occurs, it will usually happen within a few minutes to a few hours after the vaccination. If you believe your child was seriously injured by a vaccine, there is a nofault federal program that can help compensate you for his care. To learn more about the Vaccine Injury Compensation Program, see their website at These antibodies find and destroy the specific germ that is causing the infection. Later on, if the person is exposed to the same germ again, antibodies are quickly deployed to eliminate it before it can make the person sick again. Eventually they will fight off the infection, and leave the child immune to future infections. Vaccines contain the same germs that cause disease (for example, measles vaccine contains measles virus, and Hib vaccine contains Hib bacteria). When a child is vaccinated, the vaccine stimulates his immune system to produce antibodies, exactly like it would if he were exposed to the disease. No medicine is perfect, of course, but most childhood vaccines produce immunity about 90% to 100% of the time. Certainly better hygiene and sanitation can help prevent the spread of disease, but the germs that cause disease will still be around, and as long as they are they will continue to make people sick. If you look at the graph for Hib, the number drops around 1990, for pneumococcal disease around 2000 - corresponding to the introduction of vaccines for those diseases. No matter how good vaccines are at preventing disease, no matter how much they have reduced disease over the years, no matter how many lives they have saved, what if they can actually harm my baby? We will address some specific safety issues in the Frequently Asked Questions section of this booklet (page 43). During a febrile seizure a child might shake uncontrollably, become unresponsive, or even lose consciousness. About one child in 25 will have at least one febrile seizure during his childhood, usually between the ages of 6 months and 3 years. When a febrile seizure is associated with a vaccine, it is because the vaccine causes a fever, which in turn triggers the seizure. Rarely, a child may have a truly severe reaction, like encephalopathy (brain infection), or a severe allergic reaction. These are the scary possibilities that make some parents think that it might actually be better not to vaccinate their children. Second, it is sometimes hard to tell whether a reaction was actually caused by a vaccine. Any serious reaction that could be caused by a vaccine could also be caused by something else. For something that affects only one child in a hundred thousand or a million, it can be very hard to isolate the cause.