Pediatric & Adult
55 Walls Dr., Fairfield, (203) 259-7070
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Dr. Kenneth Backman, Dr. Irena Veksler, and Dr. Katherine Bloom
Researchers in Dresden, Germany, have demonstrated that allergy immunotherapy can effectively prevent asthma in patients with allergic rhinitis in a realistic setting.
Doctors reviewed routine healthcare data from German National Health Insurance beneficiaries which helped them identify a cohort of about 118,754 patients who chronically suffered from allergy symptoms but did not have asthma. This means they had not been previously diagnosed with asthma, did not have documented physician contacts due to asthma symptoms and did not have prescriptions filled for corticosteroids. They used this information to track new appearances of asthma between 2007-2012 and compared patients who had been treated with immunotherapy against those who had never been exposed to immunotherapy.
“Counts and percentages were calculated for each confounding, outcome and exposure variable,” Jochen Schmitt, MD, MPH, said. “We discovered that allergy immunotherapy being used in routine clinical care effectively prevents the onset of asthma. Most pronounced preventive effects were observed for subcutaneous immunotherapy, immunotherapy containing native allergens, and immunotherapy administered for at least three years.”
Patients with allergic rhinitis are at increased risk for the development of asthma. Allergy immunotherapy is one method of treating allergic rhinitis and it’s recognized in the U.S. by the Food and Drug Administration in two forms. The first is subcutaneous immunotherapy or allergy shots. The second is sublingual immunotherapy or allergy tablets. Both are forms of long-term treatment that decrease symptoms for many people with allergic rhinitis, allergic asthma, conjunctivitis (eye allergy) or stinging insect allergy. They work to decrease sensitivity to allergens and often lead to lasting relief of allergy symptoms, even after treatment has ended.
In total, 2,431 patients had been exposed to allergy immunotherapy (2% of the cohort). The risk of incident asthma was significantly lower in these patients – only 33 out of 1,646 patients who had a new diagnosis of asthma were exposed to immunotherapy. Patients with asthma also received, on average, higher doses of antihistamines and had more physician contact due to allergic rhinitis or allergy symptoms.
“In patients with allergic rhinitis, allergy immunotherapy should be considered to prevent asthma. By reducing the primary risks for developing asthma, we can directly address and improve the burden of the disease for the patients and present significant cost savings for the healthcare system,” Schmitt concluded.
More information on asthma and immunotherapy is available at the AAAAI website. This study was accepted in September and currently appears as an article in press in The Journal of Allergy and Clinical Immunology.
Posted on October 01, 2015 | Permalink
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Seasonal allergic rhinitis (AR) is just one of many conditions that can cause nasal congestion, and the impact on sufferers and society is substantial, including lost work productivity and impairments in sleep and quality of life. Of the four main symptoms of AR (itchiness, sneezing, runny nose, and nasal congestion), nasal congestion occurs most often and is considered by people with AR to be more bothersome than the other symptoms. With limitations placed on the over-the-counter sale of pseudoephedrine (a decongestant shown to be effective) since 2006, Phenylephrine HCL (PE) has increasingly entered the marketplace and is widely used by consumers for the treatment of nasal congestion. Based on IMS Health Incorporated state-level data it is possible that the annual cost to American society of using PE for nasal congestion is upwards of half a billion dollars. Yet despite decades of widespread use and a Food and Drug Administration (FDA) indication of 10 mg every 4 hours for the temporary relief of nasal congestion, the most effective dose of PE and duration of action for nasal congestion are unknown. In fact, there have been no large-scale, well-conducted, peer-reviewed clinical studies published supporting the effectiveness of PE for the relief of nasal congestion.
In a recently published article in The Journal of Allergy and Clinical Immunology: In Practice, Meltzer and colleagues reported results from a clinical trial that randomly assigned 539 adults with seasonal AR who were suffering from nasal congestion but were otherwise healthy to receive one of four doses of PE (10 mg, 20 mg, 30 mg, or 40 mg) or placebo tablets that looked similar to the PE tablets. Participants took the study medication for 7 days, approximately every 4 hours, and recorded in a diary, using a 4-point scale, how congested they felt. These assessments included self-evaluation of symptom severity over the preceding 12 hours and at the moment of assessment prior to the next dose.
The results showed that even though PE was well tolerated at doses up to 30 mg, none of the doses (10–40 mg) showed any statistically significant difference in nasal congestion scores compared with placebo. It is likely that similar results would be seen in patients suffering from nasal congestion due to other causes such as nasal membrane swelling from irritants and the common cold.
The study was conducted in response to calls by the FDA upon the pharmaceutical industry to conduct large, well-designed, dose-ranging studies to assess the effectiveness of PE for the relief of nasal congestion. The authors conclude that consumers and healthcare practitioners should be warned about the ineffectiveness of PE to relieve nasal congestion, and the FDA should revise their labeling for PE accordingly.
Dr. Katherine Bloom of Allergy & Asthma Care of Fairfield County comments: "For many years, pseudoephedrine was the main oral decongestant used in over-the-counter allergy and cold medications. When this was moved behind the counter (due to its use in the manufacture of "crystal meth") many pharmaceutical companies substituted phenylephrine into their products to allow them to remain OTC. Unfortunately, many patients have found these products to be less effective, and this study confirms that phenylephrine is not as effective as pseudoephedrine."
DBV Technologies recently announced it has received the green light from the Food and Drug Administration (FDA) to begin a global Phase III trial using Viaskin® Peanut (also known as the “peanut patch”). This is the first time that a drug for food allergy has reached Phase III – a step in the clinical trial process during which a drug or treatment is given to a larger group of people to confirm its effectiveness and collect information that will allow it to be used safely.
The anticipated Phase III trial, Peanut EPIT Efficacy and Safety Study (PEPITES), which will enroll children ages 4 to 11, is expected to begin later this year following submission of the final clinical trial protocol and review by the FDA. PEPITES is planned as a randomized, double-blind, placebo-controlled trial with about 260 patients from 35 sites in North America, Australia and Europe.
DBV Technologies’ primary goal is to show that its therapy significantly reduces an individual’s sensitivity to peanut; this would help them avoid a life-threatening allergic reaction from accidental ingestion. This endpoint could potentially increase the study’s clinical relevance by better showing that the therapy increases safety for people with peanut allergy. This is the first specific therapy for food allergy to be approved to enter a Phase III trial, which is the final phase before consideration by the FDA for approval in the market.
The company also plans to conduct additional separate clinical trials in younger and older patients.
Earlier this year, DBV Technologies presented clinical data on the company’s Phase 2b trial, the results of which continue to support the effectiveness and safety of the peanut patch. This data showed that 50 percent of children were able to tolerate an oral challenge of at least 300 mg of peanut protein after 12 months of treatment versus 12.9 percent in the placebo arm. The study’s authors say this threshold dose of 300 mg peanut protein is clinically relevant, as reaching this level significantly reduces the risk of allergic reactions to potential peanut traces in foods.
(Source: FARE newsletter)
Dr. Kenneth Backman of Allergy & Asthma Care comments: "This product represents an exciting advance in the potential treatment of food allergies. It offers the possibility of reducing a patient's sensitivity to peanut without the potential risks of oral desensitization. We are hopeful that phase III trials will be successful and that the patch will be available within the next few years."
The AAAAI recently commented on the safety of asthma inhalers in patients allergic to soy and peanuts despite some concern based on misperceptions regarding ingredients in the inhalers. A similar concern has been raised regarding possible food allergens in intravenous medications used for anesthesia. Propofol is an intravenous medication used for anesthesia prior to some surgical and other medical procedures and for some people on ventilators. The propofol is mixed in a liquid containing soybean oil and a substance called egg lecithin. Lecithin is a fatty substance found in some plant and animal tissues.
Patients who are allergic to foods, including soy and egg, are allergic to proteins in the foods and are not allergic to the oils or fats in the foods. Soybean oil and egg lecithin may contain trace amounts of residual protein, however no allergic reactions have been demonstrated to be caused by this. Although peanuts and soybeans are both in the legume family, the overwhelming majority of peanut-allergic patients are not clinically allergic to soy, and even if they were, would not be expected to react to soybean oil.
There are reports of reactions to propofol involving hives or other symptoms of systemic allergic reactions (anaphylaxis). However, most reports of anaphylaxis to propofol have occurred in patients without egg allergy and the vast majority of patients with egg allergy receive propofol without reaction. Some patients may be allergic to the propofol itself. Also, most patients who react after receiving propofol have received other drugs at the same time that can cause or worsen anaphylaxis, including antibiotics, muscle relaxants and narcotic pain medications. Thus, although it is clear that propofol can cause anaphylactic reactions, the cause of these reactions is unclear and appears not to be related to soy or egg allergy.
The bottom line: Patients with soy allergy or egg allergy can receive propofol without any special precautions. Any patient, whether soy or egg-allergic or not, who has an apparent allergic reaction to propofol should be evaluated by an allergist.
Additional information on food allergies.
Dr. Irena Veksler of Allergy & Asthma Care of Fairfield County comments: "Anesthesiologists have generally denied propofol to patients with a history of soy or egg allergy. It is reassuring to know that this useful anesthetic is safe in these patients."
New York Magazine has released its 2015 list of Top Doctors in the New York / Tristate area. Allergy & Asthma Care of Fairfield County is proud to announce that Dr. Kenneth Backman, the founder of Allergy & Asthma Care, is the only allergist in Connecticut included in this prestigious annual listing. To see the list of allergists in New York Magazine, click here. To learn more about Dr. Backman or our other health care providers, click on the link to the right. For an appointment with our office, please call 203-259-7070.
The recent publication of the LEAP study in the New England Journal of Medicine(click here for more) has led to recent guidance on the early introduction of peanut into the diet of high risk infants. Here is the recommendation offered by a collaboration of the American Academy of Pediatrics, American Academy of Allergy, Asthma, and Immunology, the American College of Allergy, Asthma, and Immunology, and multiple international medical societies:
Based on data generated in the LEAP trial and existing guidelines, the following interim guidance is suggested to assist the clinical decision-making of healthcare providers:
• There is now scientific evidence (Level 1 evidence from a randomized controlled trial) that healthcare providers should recommend introducing peanut-containing products into the diet of “high-risk” infants early on in life (between 4 – 11 months of age) in countries where peanut allergy is prevalent, since delaying the introduction of peanut may be associated with an increased risk of developing peanut allergy.
• Infants with early-onset atopic disease, such as severe eczema, or egg allergy in the first 4-6 months of life may benefit from evaluation by an allergist or physician trained in management of allergic diseases in this age group to diagnose any food allergy and assist in implementing these suggestions regarding the appropriateness of early peanut introduction.
Rationale for evaluating and applying this policy to a high-risk population
The LEAP study demonstrates that early peanut introduction can be successfully carried-out in high-risk population (such as the population defined in the LEAP trial). However, without intervention by healthcare providers, there is the potential that such high-risk infants will remain at risk for delayed introduction of solids and allergenic foods into their diet, because of the widespread belief that such foods may exacerbate eczema.
Accidental exposures to peanut allergens in children are more likely to occur at home than at schools, and most events are managed inappropriately, according to study results. “We discovered that children are most at risk of exposure in their own homes,” Sabrine Cherkaoui, MD, division of allergy and clinical immunology, University of Montreal, said in a press release. “Furthermore, when children do have a moderate or severe reaction to an exposure, parents and medical professionals often do not know how to react appropriately.”
Cherkaoui and colleagues recruited 1,941 children with peanut allergy from two hospitals and allergy advocacy organizations between 2004 and 2014. Patient demographics, history of atopy and initial reaction to peanut were collected through questionnaires, and accidental exposures (AEs), including food ingested, signs, symptoms, location and treatment, were recorded. Five hundred and sixty-seven AEs occurred in 429 patients across 4,589 patient-years for an annual incidence rate of 12.4%. Initial reactions to peanut were considered moderate (50.1%), mild (26.3%) and severe (11.3%).
Thirty-seven percent of AEs occurred at the child’s home, 14.3% occurred at a relative or friend’s house, 9.3% occurred at a restaurant, and 31.6% took place at unknown locations. Exposures at school were minimal: 4.9% occurred at schools prohibiting peanut, and 3% took place at schools that allowed peanut. No epinephrine was administered to 36.5% of participants with mild AEs, 25.6% of participants with moderate exposures and 14.1% of participants with severe exposures. The researchers said longer disease duration, likely due to adjustments made over time, reduced the risk for an AE (adjusted HR = 0.9; 95% CI, 0.88-0.93).
“The most significant finding of this study is the discovery that most moderate and severe accidental exposures are managed inappropriately by caregivers and physicians,” Cherkaoui said in the release. “We believe that more education is required on the importance of strict allergen avoidance and the need for prompt and correct management of anaphylaxis.”
From: Cherkaoui S, et al. Clin Transl Allergy. 2015;doi:10.1186/s13601-015-0055-x.
Dr. Katherine Bloom of Allergy & Asthma Care of Fairfield County comments: This is an interesting study that points out that accidental exposures can occur anywhere, particularly in the home. It is critically important that all patients/families have a written food allergy action plan that they have reviewed in advance."
The time a mother spends breast-feeding her child has no impact on the development of allergy sensitization in children at high risk for developing allergies, according to recent study results.
“Our thorough analyses have shown no effect of breast-feeding on the development of sensitization. This is contrary to the general opinion and current health recommendations,” Ea Cecilie Jelding-Dannemand, MSc, of the University of Copenhagen, and colleagues wrote. “This perception of breast-feeding as an important protection against allergy might cause mothers of children who are at high risk of allergy-associated diseases to feel guilty and distressed if they are not able to breast-feed exclusively for the recommended period of time.”
The researchers analyzed the data of 335 children from the Copenhagen Prospective Study on Asthma in Childhood 2000 birth cohort from August 1998 to December 2001. The children were born to mothers with a history of asthma. The researchers’ objective was to assess the effects of the duration of exclusive breast-feeding on the development of sensitization in preschool children.
Researchers observed no link between duration of breast-feeding and sensitization at 7 years based on skin prick test responses or specific immunoglobulin E levels during the study period. There also was no relation between duration of exclusive breast-feeding and outcomes in children aged 7 years such as eczema, asthma, and allergic rhinitis.
“This information should be communicated to the public, moderating the general recommendation of breast-feeding based on the lack of evidence for any protective effect against allergy in at-risk children,” the researchers wrote. From the Journal of Allergy and Clinical Immunology - Jelding-Dannemand E, et al. J Allergy Clin Immunol. 2015;doi:10.1016/j.jaci.2015.02.023.
Dr. Kenneth Backman of Allergy & Asthma Care comments: "While the many benefits of breast-feeding are well-known, there has been conflicting evidence of its effects on the development of allergies in infants. This study is reassuring in that it shows that duration of breast-feeding is not related to the subsequent development of allergies. For many reasons, it is best if mothers breastfeed for up to a year if possible, but they should not feel that they have increased their child's risk of allergies if they must stop nursing sooner."
The American Academy of Allergy, Asthma and Immunology is calling for the more frequent use of penicillin skin testing to slow the development of antibiotic resistance, according to a press release. An allergy to penicillin, which is reported by approximately 10% of the U.S. population, is linked with an unrecognized hazard, which is receiving alternative antibiotics when penicillin would usually be the drug of choice. The problem with receiving alternative antibiotics, according to the release, is that they have been linked with higher costs, greater risk for adverse effects, longer hospital stays and encouraging resistant bacterial strains.
Almost nine out of 10 people with a suspected penicillin allergy have negative penicillin skin testing and can receive penicillin safely. “Without such testing, there is an unrealized opportunity to improve healthcare outcomes and reduce rising rates of antibiotic resistance,” Robert F. Lemanske, Jr., MD, FAAAAI, president of the American Academy of Allergy, Asthma, and Immunology said in the release. “Allowing many people to return to using penicillin antibiotics should slow the development of antibiotic resistance.”
The statement comes days after a 5-year strategy was released by the White House to combat antibiotic resistance nationally.
Dr. Irena Veksler of Allergy & Asthma Care of Fairfield County, comments: "We have long known that most patients with a history of reaction to penicillin antibiotics, such as amoxicillin, will actually be able to tolerate penicillin. Penicillin skin testing is a quick, safe, effective way to determine who is not actually allergic, and allow patients to take safer and more targeted antibiotic therapy when needed. This will reduce the use of newer, broad spectrum antibiotics, and slow the development of resistance."
HOUSTON, TX – The first ever published data from the highly anticipated Learning Early About Peanut (LEAP) study offers proof that early introduction of peanuts may offer protection from the development of peanut allergies. The study was led by Professor Gideon Lack at King’s College London. “We believe the results from this trial are so compelling, and the problem of the increasing prevalence of peanut allergy so alarming that new guidelines should be forthcoming very soon,” Hugh A. Sampson, MD, FAAAAI, noted in an accompanying editorial. Sampson is a past-president of AAAAI and current Director of the Jaffe Food Allergy Institute with the Icahn School of Medicine at Mount Sinai.
Lack and the LEAP study team randomly assigned 640 infants with severe eczema, egg allergy, or both, to either consume or avoid peanuts until 60 months of age. Additional clusters were identified in the cohort: children with sensitivity to peanut extract and children without sensitivity (as determined by skin prick tests). Remarkably, the overall prevalence of peanut allergy in the peanut-avoidance group was 17.2% compared to only 3.2% in the consumption group. The prevalence of peanut allergies in children with negative skin prick tests early in life was at 13.7% in the avoidance group and 1.9% in the consumption group. Similarly, children already sensitive to peanuts reflected a 35.3% prevalence of peanut allergy in the avoidance group, compared to only 10.6% in the consumption group.
“Early consumption is effective not only in high-risk infants who show no sensitivity to peanuts early on, but it is also effective in infants who already demonstrate peanut sensitivity,” first author George Du Toit, MB, BCh, also from Kings College London explained. While additional questions remain, researchers now wonder if the LEAP study – which has demonstrated that the early introduction of peanut dramatically decreases the risk of developing a peanut allergy by a staggering 70-80% – should prompt a change in food allergy guidelines.
“There appears to be a narrow window of opportunity to prevent peanut allergy,” says Lack. “As soon as infants develop the first signs of eczema or egg allergy in the first months of life, they should receive skin testing to peanut and then eat peanut products either at home if the test is negative or first under clinical supervision if the test if positive. Infants without such symptoms should be fed peanut products from four months of life.” Lack added that this advice applies to children in countries where peanut allergy is a problem and cautions that infants should not be fed whole peanuts because of the risk of choking.
The “Randomized Trial of Peanut Consumption in Infants at Risk for Peanut Allergy” was published in The New England Journal of Medicine and presented at a Keynote address for the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Houston. Funding for the LEAP study was provided by the National Institute of Allergy and Infectious Diseases (NIAID) and Food Allergy Research & Education (FARE).
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "Previous observational studies have suggested that early introduction may be better than delayed introduction. This is the first randomized, prospective study to show that early introduction of peanut can help prevent a peanut allergy. This is groundbreaking research that will likely change the advice we give to patients daily."
The World Allergy Organization has released conditional guidelines for the use of probiotics during pregnancy, breast-feeding and infancy to prevent allergic diseases. International clinicians and researchers gathered to develop recommendations about the use of probiotics in the prevention of allergy, and they issued the suggestions after reviewing randomized controlled trials of probiotics.
Alessandro Fiocchi, MD, director of allergy at the Pediatric Hospital Bambino Gesù in Rome, and colleagues issued three conditional recommendations for using probiotics:
•in pregnant women at high risk for allergy in their children;
•in women who breast-feed infants at high risk for developing allergy; and
•in infants at high risk for developing allergies.
While the panel did not find sufficient evidence to indicate probiotic supplements reduced the risk for developing allergy in children, the panel wrote that there is a likely benefit from using probiotics in the prevention of eczema.
Question 1: In determining if probiotics should be used by pregnant women, the researchers analyzed eight reviews and 21 randomized controlled trials (RCTs). Fifteen of the studies measured and reported development of eczema in children. The risk for eczema was reduced in children whose mothers received probiotic during pregnancy compared with placebo (RR = 0.72; 95% CI, 0.61-0.85). Development of asthma or wheezing was reported in eight studies and did not vary between the probiotic and placebo (RR = 0.93; 95% CI, 0.76-1.15).
The panel acknowledged the use of probiotics during pregnancy will most likely be determined by women’s preferences. “We agreed that the values and preferences of women regarding the use of probiotics during pregnancy are likely to depend on cultural and socioeconomic background,” the panel wrote. The European Academy of Allergy and Clinical Immunology (EAACI) Food Allergy and Anaphylaxis Guidelines states there is no evidence to suggest women modify their diet or take supplements during pregnancy to prevent the development of food allergy.
Question 2: The panel asked if women who breast-feed should or should not use probiotics. Thirteen RCTs were analyzed to determine a conditional recommendation to use probiotics if the child is at great risk for developing allergy. The use of probiotics during breast-feeding reduced the rate of eczema in infants when compared with placebo (RR = 0.61; 95% CI, 0.5-0.64). But, there is some uncertainty because the analyzed research also included studies where the mothers took probiotics during pregnancy and the infants also were actively taking probiotics. The EAACI Food Allergy and Anaphylaxis Guidelines indicate there is no evidence to suggest women who breast-feed should take any supplements to prevent food allergy in their children.
Question 3: The panel asked if probiotics should be administered to healthy infants. The panel analyzed five reviews and 23 RCTs and suggested using probiotics in infants at risk for allergy. When given to infants, probiotics decreased the risk for developing eczema compared with placebo (RR = 0.81; 95% CI, 0.7-0.94). However, there was no indication probiotics affected the development of allergic rhinitis in children (RR = 0.83; 95% CI, 0.39-1.79). Although the panel suggested the use of probiotics during infancy, there was some uncertainty as to when they should be initiated. “If probiotics are used in infants, it is not clear when they should be started and how long they should be used,” the panel wrote.
Dr. Irena Veksler of Allergy & Asthma Care of Fairfield County comments: "There has been mixed data on the benefit, if any, of probiotics in preventing or controlling allergic disease. While probiotics certainly have other benefits, it is still unclear if they are beneficial in allergies. Further studies are needed."
Long-term and/or high-dose use of a class of medications used for hay fever, depression and other ills has been linked in a new study to a higher risk of dementia. The drugs — called anticholinergics — include nonprescription diphenhydramine (Benadryl) and tricyclic antidepressants like doxepin (Sinequan). This class of medications also includes older antihistamines like chlorpheniramine (Chlor-Trimeton) and “antimuscarinic” drugs for bladder control, such as oxybutynin (Ditropan).
However, the study could only point to an association between long-term or high-dose use of these drugs and a higher risk of dementia, it could not prove cause-and-effect. Also, the relationship “did not occur at the lowest dosage range but did occur at higher dosages used long-term,” said one expert, Dr. Alan Manevitz, a clinical psychiatrist at Lenox Hill Hospital in New York City. He was not involved in the new study. Manevitz also stressed that consumers “should not abruptly stop any current medication treatment but rather should first consult with their physician.”
The new study was led by Shelly Gray of the Group Health Research Institute-University of Washington. Her team explained that the anticholinergic class of medications work by blocking a neurochemical called acetylcholine, in both the brain and body. Manevitz noted that people “suffering from Alzheimer’s disease typically show a marked shortage of acetylcholine.”
The new study tracked outcomes for more than 3,500 seniors who were followed for more than seven years. Gray’s group found that people who took at least 10 milligrams per day of Sinequan, 50 mg per day of Benadryl, or 5 mg per day of Ditropan for more than three years were at greater risk for developing dementia. Manevitz noted that occasional use of these medications did not seem to be tied to a rise in dementia risk. “The risk of dementia was due to a cumulative total of exposure, not to an acute short course of treatment,” he said.
And, Gray said in an institute news release, “Older adults should be aware that many medications — including some available without a prescription, such as over-the-counter sleep aids — have strong anticholinergic effects. And they should tell their health care providers about all their over-the-counter [drug] use,” she added. However, “no one should stop taking any therapy without consulting their health care provider,” said Gray, director of the geriatric pharmacy program at the University of Washington’s School of Pharmacy. Instead, “health care providers should regularly review their older patients’ drug regimens — including over-the-counter medications — to look for chances to use fewer anticholinergic medications at lower doses,” she advised.
The study, published Jan. 26 in JAMA Internal Medicine, is the first to link higher use of anticholinergic medications to increased risk of dementia, the researchers said. It is also the first to suggest that the dementia risk associated with these drugs may not be reversible even years after people stop taking them. Manevitz called the new study “well designed,” and said the reversibility issue is a troubling one. “The general view has been that mild cognitive impairment is reversible in discontinuation of anticholinergic medication therapy,” he said, but this study seems to find otherwise.
According to Manevitz, “we need to educate patients and their families about over-the-counter medicines and alternative therapies. Also, elderly people in nursing homes tend to have a long list of medicines that need to be reviewed periodically for need to continue, interactions and redundancy.” He believes doctors should think about substitutes for anticholinergics when possible, prescribe the lowest dose possible, and stop the medication as soon as is medically advisable.
Gray offered similar advice. “If providers need to prescribe a medication with anticholinergic effects because it is the best therapy for their patient, they should use the lowest effective dose, monitor the therapy regularly to ensure it’s working, and stop the therapy if it’s ineffective,” she suggested. She said that substitutes are available for some anticholinergic drugs, including a selective serotonin re-uptake inhibitor (SSRI) antidepressant like citalopram (Celexa) or fluoxitene (Prozac) for depression, or a second-generation antihistamine such as loratadine (Claritin), fexofenadine (Allegra), or cetirizine (Zyrtec) for allergy relief.
Dr. Katherine Bloom of Allergy & Asthma Care of Fairfield County comments: "In recent years we've discouraged the use of older, first-generation antihistamines, in favor of newer, second generation agents. This is due to the increased risk of side effects including drowsiness and dry mouth/ eyes (from the anticholinergic effects.) This study gives one more reason to avoid the older antihistamines, though of course further studies are necessary to confirm the findings."
Prenatal and early-life exposure to antibiotics does not seem to cause asthma in children, according to large new study. "Our results indicate that there doesn't seem to be a causal link between antibiotic treatment during pregnancy or early in life and childhood asthma," lead author Dr. Anne Ortqvist of the Karolinska Institute in Stockholm told Reuters Health by email. "Instead, we suggest that factors that are shared within families, such as genetic predisposition to respiratory infections and asthma, consultation patterns or other home and environmental factors, together with confounding by respiratory infections, have biased previous results."
Given that the rise in antibiotic use occurred in tandem with increases in asthma prevalence in children, several observational studies have been conducted to evaluate whether the two are related, but results have been mixed, Dr. Ortqvist and her team write in their report, published online November 28 in BMJ. In the new study, the researchers sought to account for familial factors by using sibling controls. To address the possibility of confounding by indication and reverse causation, they examined whether specific antibiotic types were linked to asthma. They looked at more than 493,000 children born in 2006-2010, and identified nearly 181,000 who were eligible for sibling analyses.
While prenatal exposure to antibiotics overall was linked to an increased risk of asthma (hazard ratio, 1.28), sibling analyses did not find an association (HR, 0.99), the researchers found. The risk associated with asthma was more pronounced when looking at antibiotics used to treat respiratory infections (HR, 4.12) versus antibiotics used to treat urinary tract or skin infections in children (HR, 1.54). However, sibling analyses reduced the association for exposure to antibiotics for respiratory infections (HR, 2.36), and there was no significant association between the use of antibiotics for urinary tract or skin infections and asthma risk (HR, 0.85).
"Our study suggests that antibiotics do not cause asthma, however, considering the threat of antibiotic resistance worldwide it is of great importance that antibiotics are used carefully," Dr. Ortqvist said. "So, if clinicians' use of antibiotics should change in any way that would be to consider the necessity of treatment with antibiotics for each patient one more time before prescribing it." She added: "We would like to emphasize the importance of correctly diagnosing children with respiratory symptoms, where suspected symptoms of asthma should be separated from respiratory infections, and treated according to guidelines. Also, as the majority of respiratory infections in young children are caused by viruses, the need of treatment with antibiotics in these children may be questioned."
Dr. Ortqvist said she and her colleagues are planning to use Swedish population-based data to investigate whether early antibiotic exposure is associated with other childhood illnesses.
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "There have been many studies trying to determine the causes and risk factors for childhood asthma. While early life antibiotics have been implicated in some smaller studies, this well designed study did not identify an association. Many studies continue to try to identify the cause of the increase in asthma and allergies in children and adults."
A chemical called methylisothiazolinone, used as a preservative in many baby wipes, soaps, and other household products, is responsible for many cases of contact dermatitis, which can cause eczema of the hands and other areas. The compound, often referred to as MI, was named the 2013 allergen of the year by the American Contact Dermatitis Society. See this interesting article from the New York Times.
This contact allergy can be detected through patch testing. If you have eczema affecting your hands or other areas and suspect a contact allergy, Allergy & Asthma Care of Fairfield County can perform patch testing for the common contact allergens. Please contact our office at 203-259-7070.
Dr. Irena Veksler of Allergy and Asthma Care of Fairfield County comments: "This contact allergen has been on our patch test panel for some time, but it has been an underappreciated cause of contact allergies and hand eczema. Hand eczema is often due to irritants and not allergens, but it is always important to rule out contact allergens as a cause."
A recent study by a Japanese institute found that consistently using emollients on newborn babies can prevent atopic dermatitis (eczema) and food allergies later in life. Emollient therapy with newborn babies is an inexpensive and easy way to prevent and treat the increasing global epidemic of eczema and prevent food allergies.
The National Center for Child Health and Development in Tokyo conducted a small-scale study. Researchers found that using emollients regularly during the first few weeks of life can help the immune system and keep it functioning properly. Researchers studied two groups of newborns. One group used emollients regularly on the babies. Another group had no treatment. The researchers studied 118 newborns for 32 weeks.
Results showed 19 babies developed atopic dermatitis (eczema) in the group using regular emollients. 28 babies developed atopic dermatitis (eczema) in the group using no treatment. This is the first study of it’s kind worldwide and suggests that using emollient therapy can reduce the risk of developing atopic dermatitis (eczema) by 30 percent.
The National Center for Child Health and Development stated in a recent press release that emollient therapy prevents the skin from drying out and cracking. Dry cracked skin allows irritants to enter the body exposing immune cells to these irritants. The immune system then boosts the body’s production of antibodies to combat these irritants, resulting in over-production. This over-production of antibodies causes the symptoms of allergy such as atopic dermatitis (eczema) and allergies and food allergies.
Toru Sato, the center’s spokesman, stated “It was known before that dry skin would cause eczema. One of the achievements of this study is that we came up with clear figures for the probability of developing eczema. Researchers are now looking at why some babies in the group still went on to develop eczema. Another important point is that the study suggests atopic skin problems could be linked to other allergic reactions, such as asthma and hay fever, that may appear later in life.”
How to apply this study? If you have a young baby, applying an emollient or moisturizer after their bath is a good way to keep their skin soft and supple. Keeping newborn skin healthy is easy and may prevent them from developing eczema, allergies and food allergies.
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "We've long known that moisturization is a critical component of eczema skin care, and that good skin care can help prevent eczema flares. There is now evidence that moisturization in early life can actually prevent eczema. We look forward to more studies on this topic."
Babies exposed to traces of peanut protein in house dust may have a higher risk of peanut allergy researchers say. In a new UK study, published online in the Journal of Allergy and Clinical Immunology, exposure to peanut protein in house dust doubled the chance of having a peanut allergy. In children who have eczema, the risk of having peanut allergy was even higher.
Around 2% of school children in the UK are allergic to peanuts. Researcher Helen Brough, from the department of paediatric allergy at King's College London and colleagues from the University of Manchester and the University of Dundee , note that eczema "is often cited as the first step in the allergic march." They say that exposure to peanut proteins in dust through eczema-inflamed skin can trigger a peanut allergy. How peanut allergies develop is not yet clear, says Dr Carla Davis, a specialist in children's allergies at Texas Children's Hospital in Houston in the US. There is still plenty of controversy in the field, she says. For instance, some researchers are testing a "patch" for people who already have a peanut allergy that would introduce the allergen through the skin to build tolerance. That seems to contradict the findings in this study, she says.
The researchers found out how much peanut protein infants were exposed to by measuring dust vaccuumed from the patients' living rooms. They studied 359 children who had a high risk of developing a peanut allergy because they were already allergic to cow's milk or eggs, or had moderate or severe levels of eczema and had allergies to those foods. "This study adds to the growing body of evidence that exposure to peanut via a damaged skin barrier [as in eczema] may increase the risk of peanut allergy,” Helen Brough says in a news release.
Professor Gideon Lack, senior author from the Department of Paediatric Allergy, King's College London, adds: "This is further evidence for the dual-allergen-exposure theory which suggests food allergies develop through exposure to allergens via the skin, likely through a disrupted skin barrier, whilst consumption of these food proteins early in life builds up tolerance in the body. Previous guidelines recommending that mothers should avoid peanuts during pregnancy and breastfeeding have now been withdrawn. Ongoing studies at King's aim to find if exposure to solids in early infancy might actually help to prevent allergies. It may be that the timing and balance of skin and oral exposure to a particular food early in life determines whether a child develops an allergy or tolerance to that food."
Several people involved in the study report receiving support from, or consulting for, pharmaceutical and other companies and organisations, including the US National Peanut Board.
Dr. Irena Veksler of Allergy & Asthma Care of Fairfield County comments: "It has long been known that patients with eczema are at increased risk of food allergies. This study identifies one possible cause of this increased risk, and suggests a possible cause of peanut allergy in particular. More studies are definitely needed."
Eosinophilic esophagitis (EoE) is an emerging allergic disorder predominantly triggered by food allergens. Several dietary interventions have been evaluated in adults so far. Based on amino acid-based formulas, elemental diet is the most effective, but is also impractical, whereas elimination diet based on skin testing has shown suboptimal cure rates (26%-36%). An empiric six-food group elimination diet (SFGED), prospectively evaluated in unicenter studies, has achieved remission in over 70% EoE patients. Still, the majority (65%-85%) of SFGED responders have just one or two causative foods identified after six food-group challenges and endoscopies, so some dietary restrictions and subsequent endoscopies after food challenge may be unnecessary.
Now, in a study recently published in The Journal of Allergy and Clinical Immunology, Javier Molina-Infante and colleagues present the results of the first prospective multicenter study on empiric elimination diet for EoE, evaluating a simplified four-food group elimination diet (FFGED) (dairy products, wheat, egg and legumes) for adult EoE.
The efficacy of this six week FFGED was evaluated in 52 consecutive patients from four Spanish hospitals. In those unresponsive to FFGED, a rescue SFGED was proposed. Among patients responsive to a FFGED, 78% completed the individual food reintroduction process.
The study shows 54% of adult EoE patients achieve clinicohistological remission on an empiric FFGED; in addition, almost a third of non-responders to FFGED could be effectively rescued with a SFGED, coming to an overall effectiveness of 72%. Therefore, 3 out of every 4 adult patients achieving remission on a SFGED may achieve it on a FFGED, a less restrictive dietary intervention that requires fewer endoscopies and shortens the food reintroduction process. After food reintroduction, all FFGED responders had just 1 or 2 food triggers identified. The most common food triggers were cow´s milk (50%), egg (36%) and wheat (31%), with milk being the only causative food in 27% of adult patients. Results were consistent among the four participating centers.
This study underscores the general applicability of dietary interventions for adult EoE in clinical practice. This multistage, empiric, dietary approach (FFGED followed by SFGED) may be recommended to simplify dietary management for EoE patients, since a FFGED is a simpler, cheaper and less inconvenient initial dietary intervention to screen a majority of EoE patients with one or two food triggers.
(from AAAAI.org website) For more info on eosinophilic esophagitis, click here
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "Eosinophilic esophagitis is a relatively newly identified disorder about which we continue to learn more. Food elimination diets have clearly been very effective in children, but in adults results have been mixed. This study demonstrates that food elimination diets can be quite helpful in adults, even while making them easier by reducing the number of foods avoided. Due to the difficulty in eliminating even this smaller number of foods, many adults choose to pursue swallowed "inhaled" steroids, which are highly effective."
A study in the Annals of Allergy, Asthma, and Immunology examined the effects of dairy intake during pregancy (Miyake Y. Ann Allergy Asthma Immunol. 2014;113:82-87.):
Higher maternal intake of total dairy products, cheese, yogurt and calcium during pregnancy was associated with a reduced risk for infantile eczema, asthma and atopic eczema in children, according to study results.
Researchers in Japan studied 1,354 mother-child pairs (mean maternal age, 31.5 years) to determine the association between maternal consumption of dairy foods, calcium and vitamin D during pregnancy and childhood allergic disorders in children aged 23 to 29 months. A diet history questionnaire was administered between April 2007 and March 2008 to determine maternal intake during pregnancy. International Study of Asthma and Allergies in Childhood criteria defined wheeze and eczema, while a questionnaire completed by mothers determined physician-diagnosed asthma and atopic eczema.
Reduced risk for infantile eczema was significantly associated with higher maternal intake of total dairy products (adjusted OR between extreme quartiles, 0.64; 95% CI, 0.42-0.98). A reduced risk for physician-diagnosed infantile asthma correlated with a greater maternal intake of cheese (aOR=0.44; 95% CI, 0.18-0.97).
Yogurt (aOR=0.49; 95% CI, 0.2-1.16) and calcium consumption (aOR=0.34; 95% CI, 0.12-0.84) during pregnancy showed inverse associations with physician-diagnosed infantile atopic eczema. A significant association existed between maternal vitamin D consumption during pregnancy and infantile eczema (aOR=1.63; 95% CI, 1.07-2.51).
“The current prebirth cohort study in Japan suggests that higher maternal intake of total dairy products, cheese, yogurt and calcium during pregnancy may reduce the risk of infantile eczema in the last 12 months, physician-diagnosed asthma, physician-diagnosed atopic eczema, and physician-diagnosed atopic eczema, respectively,” the researchers concluded. “Higher maternal intake of vitamin D during pregnancy may increase the risk of infantile eczema in the last 12 months.
“Further well-designed prebirth cohort studies with accurate assessment of dietary habits during pregnancy and childhood allergic disorders are required to confirm these findings.”
Dr. Katherine Bloom from Allergy & Asthma Care of Fairfield County comments:"While this study needs to be confirmed, it is encouraging that something as simple as increasing the intake of dairy products may have the potential to help prevent eczema and allergic diseases in children."
Posted on September 17, 2014 | Permalink
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The American College of Allergy, Asthma and Immunology has warned parents of children with asthma and allergies to be aware of their child’s symptoms regarding enterovirus D68.
“If your child seems to be struggling to breathe and their normal asthma medications aren’t working, get him or her to the emergency department as soon as possible,” allergist Bradley Chipps, MD, a spokesman for theACAAI, said in a press release. “The most important thing is for every child with asthma to have a personalized action plan, created with his or her allergist, [which] helps quickly identify when a child … needs immediate, emergency attention.”
Although enterovirus D68 symptoms first appear as a common cold, they can quickly move to more severe respiratory symptoms including wheezing and difficulty breathing, the release said.
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "While many children affected by enterovirus D68 may develop an illness no worse than the common cold, this virus can cause very serious and sudden respiratory complications. If your child becomes ill and develops asthma symptoms that are not quickly and easily reversed with the quick relief inhaler (albuterol or levalbuterol,) contact your physician immediately. If your child is in distress or struggling to breathe, do not hesitate to seek emergency care."
Posted on September 17, 2014 | Permalink
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Surveyed pediatric patients with food allergies, and accompanying parents and families did not always carry self-injectable epinephrine, according to recent survey results. Researchers surveyed patients or families of patients with a documented history of food allergy during a 30-day follow-up period at the Nationwide Children’s Hospital outpatient allergy clinic, Columbus, Ohio. Age, previously diagnosed food allergies, diagnostic method, symptoms associated with previous food reactions and comorbid atopic conditions were collected. Information about carrying epinephrine auto-injector also was requested.
Thirty-five surveys were returned, and 20% of respondents reported a previous allergic reaction to food requiring treatment with self-administered epinephrine. Twenty-nine percent of those respondents had self-injectable epinephrine with them during the survey. Of the patients with self-injectable epinephrine during the survey, almost 90% had the weight-appropriate dose, but almost 50% of the auto-injectors were expired. While 60% of patients endorsed always carrying self-injectable epinephrine, only 40% of patients had the product available during the survey.
Nearly 90% of respondents reported peanut allergies, but only 43% of the patients had self-injectable epinephrine available. Accidental exposure to a food allergen was reported by 30% of patients, but only one-third of them had epinephrine available during the survey. Availability in other places such as the home, car or school, expiration of previous prescription, cost, and not knowing that it should always be carried were reasons given for not having self-injectable epinephrine with them.
“It will be necessary to continue to foster relationships with patients and their families, teachers, school administrators and staff, and community leaders to provide comprehensive food allergy care,” the researchers concluded. “Moreover, we must routinely evaluate our educational methods with respect to epinephrine efficacy and access; if these methods are ineffective it will be necessary to improve them.”
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "We have long known that one of the strongest risk factors for fatality in patients with food allergy is the absence of immediately available epinephrine. While prescribing of epinephrine autoinjectors is on the rise, unfortunately many patients with food allergy do not carrry them at all times. This is an important issue that education and frequent reminders can hopefully help overcome."
MILWAUKEE, WI – Warmer weather means more time outdoors, but spending time outside brings with it the chance of coming in contact with stinging insects, which are among the most common triggers of a serious, life-threatening reaction called anaphylaxis. However, a new paper in The New England Journal of Medicine cites venom immunotherapy as the best treatment option for people who are allergic to stinging insects as it can reduce the risk of a future severe reaction to less than 5%.
Written by American Academy of Allergy, Asthma & Immunology (AAAAI) Executive Vice President Thomas B. Casale, MD, FAAAAI, and A. Wesley Burks, MD, FAAAAI, a past President, the paper follows the case of a 24-year-old woman who was stung while drinking soda at a picnic. The woman began experiencing symptoms indicative of anaphylaxis minutes after being stung, including swelling of the lips, light-headedness, difficulty swallowing and hives. She was transported to a local emergency room and treated with epinephrine. After being observed for several hours, she was discharged and given autoinjectable epinephrine.
“As far as long-term therapy for people with stinging insect allergy, avoiding exposure to these insects is key, but the only treatment option that will actually prevent life-threatening anaphylactic reactions is venom immunotherapy,” said Dr. Casale.
Patients who have experienced a severe allergic reaction to an insect sting should see an allergist/immunologist, who can provide appropriate testing and determine if venom immunotherapy is the right treatment option. Venom immunotherapy is given in the form of shots, and about 80 to 90% of patients who receive it for 3 to 5 years do not have a severe reaction to a future sting.
“The other important thing to keep in mind is that patients with venom-specific IgE who have had a severe allergic reaction are at higher risk of having another severe allergic reaction,” explained Dr. Burks. “It is imperative for these individuals to carry autoinjectable epinephrine and know how to use it in an emergency.”
Epinephrine is the first-line treatment for anaphylaxis. In fact, the AAAAI recently released a second list for the ABIM Foundation’s Choosing Wisely® initiative that included an item highlighting the importance of epinephrine because data indicate that antihistamines are overused as the first-line treatment of anaphylaxis. Overuse of antihistamines, which do not treat the cardiovascular or respiratory symptoms of anaphylaxis, can delay treatment with epinephrine. Fatalities during anaphylaxis have been associated with delayed administration of epinephrine. Anyone who believes they are having an anaphylactic reaction should use autoinjectable epinephrine and seek medical attention immediately.
More information on stinging insect allergy, anaphylaxis and immunotherapy is available at the AAAAI website, www.aaaai.org
A recently published multi-center study found that supplemental vitamin D did not help patients with low vitamin D blood levels and symptomatic asthma. The trial, funded by the National Heart Lung and Blood Institute, failed to demonstrate any benefit of vitamin D on the primary measure - time to first treatment failure – or on eight of nine secondary measures.
“These findings do not support a strategy of therapeutic Vitamin D3 supplementation in patients with symptomatic asthma,” wrote the authors, who included Richard Martin, MD, chair of medicine at National Jewish Health, and Michael Wechsler, MD, director of the asthma program at National Jewish Health.
Earlier studies had associated low vitamin D blood levels with more asthma symptoms and medication use, and with reduced response to the mainstay asthma medication, inhaled corticosteroids.
The Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma (VIDA) trial was conducted at nine academic medical centers participating in the NHLBI’s AsthmaNet clinical research network. It randomized 408 adults with low vitamin D and mild/moderate asthma to receive the inhaled corticosteroid ciclesonide supplemented with either high-dose vitamin D3 or placebo. Participants were then monitored over 28 weeks for the occurrence of worsening asthma.
Vitamin D3 supplementation did not reduce the proportion of participants who experienced at least one treatment failure (28 percent vs. 29 percent in placebo) or one exacerbation (13 percent vs. 19 percent) nor the overall exacerbation rate. More of the vitamin D treated patients were able to reduce their inhaled steroid dose by 75 percent compared to those treated with placebo (89 percent vs. 80 percent).
The findings were presented on May 18, 2014, at the American Thoracic Society annual meeting and concurrently published in the Journal of the American Medical Association.
Dr. Katherine Bloom of Allergy & Asthma Care of Fairfield County comments: "Much has been learned about the benefits of vitamin D over the past several years. There has been some preliminary evidence that vitamin D supplementation might benefit asthma patients, but this well-constructed study demonstrates minimal effect. More studies need to be performed, but at this time, we cannot recommend vitamin D supplementation in the treatment of asthma."
The FDA approved the ragweed allergy treatment Ragwitek, the third sublingual immunotherapy (SLIT) approval last month. The announcement followed that of Merck's other SLIT agent, the Timothy grass pollen allergy tablet Grastek, on Tuesday and that of Greer's multi-grass pollen immunotherapy tablet Oralair earlier in April. While under-the-tongue drops made off-label from subcutaneous allergy shot extracts have been used by some practitioners, no SLIT agents had been FDA approved before. The liquid extracts manufactured for injections have generally been too weak to have clinical effectiveness when administered sublingually, but the new sublingual tablets are high dose and are proven effective.
Ragwitek gained approval for treatment of short ragweed pollen-induced allergic rhinitis, confirmed by a positive skin test or in vitro testing for pollen-specific immunoglobulin-E antibodies, with or without conjunctivitis, in adults ages 18 through 65. That upper age limit had been the source of some dissension on the FDA advisory panel that recommended approval. The pivotal trials included no patients over age 51, so a few panel members felt the evidence wasn't sufficient for older patients.
The other two SLIT agents approved have gained an indication for pediatric use, but that wasn't sought or studied with Ragwitek. But the Ragwitek approval otherwise followed closely with that of the grass allergy SLIT agents. It was approved for once daily use starting 12 weeks before the start and continued through the offending pollen season, which typically runs from late summer to early fall. The first dose should be taken in-office and the patient observed for at least 30 minutes for potential adverse reactions.
The most common adverse reactions reported with Grastek and Ragwitek have been itching in the mouth and ears and throat irritation, but the drug carries a boxed warning of the risk of severe allergic reactions. Due to that risk, patients should be prescribed auto-injectable epinephrine and trained in its use.
Patients with severe, unstable, or uncontrolled asthma or a history of any severe systemic allergic reaction, eosinophilic esophagitis, or any severe local reaction after taking any SLIT agent shouldn't get Ragwitek.
Dr. Kenneth Backman of Allergy & Asthma Care of Fairfield County comments: "This adds two more options to the new category of sublingual immunotherapy tablets, the first under-the-tongue allergen immunotherapy that has proven effectiveness to the satisfaction of the FDA. It is exciting to have this new treatment option available, and look forward to discussing this and other options with our patients."
The FDA has approved the first and only sublingual oral immunotherapy formulation, Oralair, a sublingual dissolving tablet for grass allergies in the United States.
Oralair (sweet vernal, perennial rye, Orchard, Timothy and Kentucky blue grass mixed pollens allergen extract, Greer/Stallergenes) is to be used as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin or blood testing for grass pollen-specific IgE antibodies for any of the five grass species contained in the product. It is indicated for patients aged 10 to 65 years.
“While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider’s office. Oralair can be taken at home after the first administration.”
The first dose would be administered at a doctor’s office. Data indicate that the drug be initiated 4 months before the expected onset of each grass pollen season and continued throughout the season. In clinical trials, Oralair was well-tolerated; the most common adverse events were oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, and oropharyngeal pain. The drug contains a black boxed warning due to the drug’s potential for anaphylaxis and severe laryngopharyngeal edema. Oralair is contraindicated (not recommended) in patients with severe, unstable, or uncontrolled asthma, or with a history of severe systemic or local reaction to sublingual allergen immunotherapy.
Merck and Danish partner ALK Abelló also are expected to launch their rival agent, Grastek, later this year, according to a press release. Oralair was first approved in the European Union in 2008 and is marketed in Canada, Australia and Russia to treat grass pollen allergy.
Dr. Irena Veksler of Allergy & Asthma Care of Fairfield County comments: "This is exciting as it represents the first FDA approved sublingual immunotherapy in the United States. While most studies have found that subcutaneous (injected) allergen immunotherapy is more effective than sublingual, this is an option for patients whose main allergen is grass pollen, and who desire a way to build their immunity to grass pollen without injections. While some practitioners in this country have offered sublingual drop immunotherapy, this has generally been at doses far too low to have any clinical effect. These grass pollen tablets, while less effective than injections, should provide significant improvement in symptoms."