FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr

EpiPen

The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.

While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated. Consumers should keep and use their current EpiPens if needed until they get a replacement. Consumers should contact Mylan at 800-796-9526 or customer.service@mylan.com with any questions.

As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens, particularly if the device did not activate.

At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. Consumers who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date.

Product/Dosage NDC Number Lot Number Expiration Date
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 5GN767 April 2017
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 5GN773 April 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM631 April 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM640 April 2017
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 6GN215 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM082 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM072 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM081 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM088 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM199 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM091 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM198 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM087 October 2017

 

The FDA asks health care professionals and consumers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program, by:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm550170.htm

Nonceliac Wheat Sensitivity is associated with Autoimmune Disease

There is much interest in wheat sensitivity in people without celiac disease, many of these patients have been labeled with nonceliac wheat sensitivity. Little is known about any risks associated with nonceliac wheat sensitivity. A recent study published in the journal of Gastroenterology evaluated autoimmune diseases in patients with nonceliac wheat sensitivity and investigated whether they carry the autoimmune antibody (ANA).

The study looked at patients who were given the diagnosis of nonceliac wheat sensitivity, celiac disease and control subjects. The ANA (autoimmune antibody) was measured in 3 groups. The authors concluded from the study that significantly higher proportions of patients with nonceliac wheat sensitivity or celiac disease have autoimmune disorders with positive ANA’s. This data provides physicians with an awareness that patients with nonceliac wheat sensitivity might have an increased risk of autoimmune diseases.

Nonceliac wheat sensitivity remains a not well defined clinical condition. In fact there are some doubts about whether it is a real diagnosis. This study showed a higher frequency of autoimmune diseases, in particular thyroiditis, psoriasis and type 1 diabetes mellitus were reported.

Allergists see many patients who are concerned regarding gluten allergy, many patients may in fact have nonceliac wheat sensitivity. This is relatively new diagnosis that there is not much information about. These are patients who do not have celiac disease or wheat allergy, but do have problems with eating gluten and/or wheat. Although allergy testing may be negative for these patients, this study shows that patients with nonceliac wheat sensitivity may have some autoimmune issues. There is still a lot to learn about nonceliac wheat sensitivity and as more studies come out we will learn more about it.

Celiac disease has been in the news a lot recently http://allergylosangeles.com/allergy-blog/gluten-free-in-the-news/

As always speak to your doctor about any concerns that you have regarding gluten or wheat.

Update on Early Peanut Introduction and Prevention of Allergy

Consensus Communication on Early Peanut Introduction and the Prevention of Peanut Allergy in High-Risk Infants

On behalf of American Academy of Asthma Allergy and Immunology, American Academy of Pediatrics, American College of Allergy, Asthma & Immunology, Australasian Society of Clinical Immunology and Allergy, Canadian Society of Allergy & Clinical Immunology, European Academy of Allergy and Clinical Immunology, the Israel Association of Allergy and Clinical Immunology, the Japanese Society for Allergology, Society for Pediatric Research, and the World Allergy Organization

Introduction and Rationale

Peanut allergy is an increasingly troubling global health problem, which affects between 1-3% of children in many westernized countries. Although multiple methods of measurement have been used and specific estimates differ, there appears to be a sudden increase in the number of cases in the past 10 – 15 year period, suggesting that the prevalence may have tripled in some countries, such as the USA. Extrapolating the currently estimated prevalence, this translates to nearly 100,000 new cases annually (in the USA and UK), affecting some 1 in 50 primary school-aged children in the USA, Canada, UK, and Australia. A similar rise in incidence is now being noted in developing countries such as Ghana.1-6

The purpose of this brief communication is to highlight emerging evidence to existing guidelines regarding potential benefits of supporting early, rather than delayed, peanut introduction during the period of complementary food introduction in infants. The recent study, entitled “Randomized Trial of Peanut Consumption in Infants at Risk for Peanut Allergy (Learning Early About Peanut – LEAP Trial),” demonstrated a successful 11% – 25% absolute reduction in the risk of developing peanut allergy in high-risk infants (and a relative risk reduction of up to 80%) if peanut was introduced between 4 and 11 months of age. In light of the significance of these findings, this document serves to better inform the decision-making process for healthcare providers regarding such potential benefits of early peanut introduction. More formal guidelines regarding early-life, complementary feeding practices and the risk of allergy development will follow in the next year from NIAID-sponsored Working Group and EAACI, and thus this document should be considered as interim guidance.

Summary of New Evidence

In the LEAP trial, 640 high-risk UK infants (See Textbox 1) between the ages of 4 to 11 months were randomized to consume peanut products at least three times a week (6 g of peanut protein; equivalent to 24 peanuts or 6 teaspoons of peanut butter per week) or to completely avoid peanut products for the first five years of life. This included 542 infants found to have negative skin prick tests (SPT) to peanut at study entry, and 98 infants with SPT wheal diameters to peanut between 1 to 4 mm (minimally SPT positive) at study entry. An additional 76 children were excluded from study entry prior to randomization based on SPT > 5mm, which was assumed to have a very high likelihood of reacting to a peanut challenge. In an Intention-To-Treat (ITT) analysis, 17.2% in the peanut avoidance group compared to 3.2% in the peanut consumption group developed food challenge-proven peanut allergy by age 5 years, corresponding to a 14% absolute risk reduction, a number needed to treat (NNT, e.g. number of persons needed to be treated for one to receive benefit) of 7.1, and a relative risk reduction of 80%.7

When examined in further detail, the isolated beneficial effects for both the primary and secondary prevention of peanut allergy translated to a NNT = 8.5 within the SPT negative and NNT = 4 within the minimally SPT positive infants. Secondary analyses also showed similar levels of prevention in White, Black and Asian (Indian and Pakistani) children. Overall, the risk of early introduction in this group was low– 7 of the 319 children randomized to the consumption group reacted to peanut at the baseline food challenge suggesting that peanut food challenges and introduction, even in minimally SPT positive infants, is safe and
feasible. Six children in the consumption group developed peanut allergy during the study indicating that peanut allergy can still develop despite attempts at primary and secondary prevention. Finally, the LEAP trial only included high-risk infants with a minimal or negative SPT to peanut, and therefore does not address a strategy for those without these risk factors for developing peanut allergy.7

How Does The LEAP Trial Affect Present Guidance for Early Complementary Feeding Practices?

Existing guidelines pertaining to the early introduction of complementary foods have indicated that the introduction of highly allergenic foods, such as peanut, need not be delayed past 4 or 6 months of life. However, they do not actively recommend introduction of peanut between 4 – 6 months of age in high-risk infants, and some of these guidelines specify that those infants considered at risk for the development of allergic disease are strongly recommended to first consult an expert.8-14

The LEAP data provide Level 1 evidence that the practice of early peanut introduction is safe and effective in selected high-risk infants. This study is the first prospective, randomized trial of early peanut intervention, and informs provider decision-making regarding high-risk infants, including those already with a positive peanut SPT but not yet clinically reactive, to receive the benefits noted in the LEAP study, which may reduce the risk of developing peanut allergy up to 80%.

Of note, since children with lesser risk factors for peanut allergy were excluded from enrollment in LEAP, there are no prospective, randomized data investigating the benefit or risk of early peanut introduction in the general to low-risk populations. However, multiple guidelines have not recommended delaying allergen introduction in these populations. On this basis, this communication is limited to helping integrate the findings learned in the LEAP trial to other similar high-risk children in more diverse settings internationally.

Interim Guidance Regarding Early Peanut Introduction

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 (see Text Box 1 for example LEAP criteria), 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. Evaluation of such patients may consist of performing peanut skin testing and/or in- office observed peanut ingestion, as deemed appropriate following discussion with the family. The clinician may perform an observed peanut challenge for those with evidence of a positive peanut skin test to determine if they are clinically reactive before initiating at-home peanut introduction. Both such strategies were used in the LEAP study protocol.
Adherence in the LEAP trial was excellent (92%) with infants randomized to consume peanut ingesting a median of 7.7 g peanut protein (interquartile range: 6.7 – 8.8 g)/week during the first 2 years of the trial compared to a median of 0 g in the avoidance group (see Text Box 2 for examples of peanut-containing foods utilized in the LEAP trial). While the outcome of the LEAP regimen was
excellent, the study does not address use of alternative doses of peanut protein, minimal length of treatment necessary to induce the tolerogenic effect, or potential risks of premature discontinuation or sporadic feeding of peanut.

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 a 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.

Future more extensive guidelines will be forthcoming from the NIAID Working Group and EAACI Guidelines Group with their multidisciplinary stakeholders. These groups will consider all the available data and determine whether there is sufficient evidence to apply prevention strategies to the general population. However, engagement of the primary care, allergy and dermatology communities to rapidly implement these findings and change the culture of early feeding practices is essential, and the forthcoming NIAID Working Group’s and EAACI Guidelines Group’s documents will better clarify a best-practices approach.

Acknowledgements:

Primary Contributors: (AAAAI) David Fleischer, MD; (AAP) Scott Sicherer, MD; (ACAAI) Matthew Greenhawt, MD; (ASCIA) Dianne Campbell, MB BS FRACP PhD; (CSACI) Edmond Chan, MD;
(EAACI) Antonella Muraro, MD, PhD & Susanne Halken, MD; (ISACI) Yitzhak Katz, MD; (JSA) Motohiro Ebisawa, MD, PhD; (SPD) Lawrence Eichenfield, MD; (WAO) and Hugh Sampson, MD.

LEAP Study Team: Gideon Lack, MD, (WAO); George duToit, MD; and Graham Roberts, MD (EAACI); and Tee Bahnson, PhD, (Rho, Inc).

Secondary Contributors: (AAAAI) Jonathan Hourihane, MD, Jonathan Spergel & Michael Young, MD; (ACAAI) Amal As’aad, MD; (ASCIA) Katrina Allen, BMedSc MB BS FRACP PhD & Susan Prescott, BMedSc MB BS FRACP PhD; (CSACI) Sandeep Kapur, MD; (JSA) Hirohisa Saito, MD, PhD; (EAACI) Ioana Agache, MD, Cezmi Akdis, MD, PhD, Hasan Arshad, MD, Kirsten Beyer, MD, Anthony Dubois, MD, Philippe Eigenmann, MD, Monserrat Fernandez-Rivas, MD, Kate Grimshaw, Karin Hoffman –Sommergruber, PhD, Arne Host, MD, Susanne Lau MD, Liam Mahoney, MD, Clare Mills, PhD, Nikos Papadopoulos, MD; (ISACI) Nancy Agmon- Levin, MD, and Aharon Kessel , MD; (SPD) Richard Antaya, MD, Beth Drolet, MD; (WAO) Lanny Rosenwasser, MD.

References

1. Nwaru BI, Hickstein L, Panesar SS, et al. The epidemiology of food allergy in Europe: a systematic review and meta-analysis. Allergy 2014;69:62-75.
2. Osborne NJ, Koplin JJ, Martin PE, Gurrin LC, Lowe AJ, Matheson MC, et al. Prevalence of challenge- proven IgE-mediated food allergy using population-based sampling and predetermined challenge criteria in infants. J Allergy Clin Immunol. 2011;127:668-76.

3. Venter C, Hasan Arshad S, Grundy J, et al. Time trends in the prevalence of peanut allergy: three cohorts of children from the same geographical location in the UK. Allergy 2010;65:103-8.
4. Sicherer SH, Muñoz-Furlong A, Godbold JH, Sampson HA. US prevalence of self-reported peanut, tree nut, and sesame allergy: 11-year follow-up. J Allergy Clin Immunol 2010;125:1322-6.

5. Soller L, Ben-Shoshan M, Harrington DW, Fragapane J, Joseph L, St Pierre Y, et al. Overall prevalence of self-reported food allergy in Canada. J Allergy Clin Immunol. 2012;130:986-8.
6. Amoah AS, Obeng BB, Larbi IA, Versteeg SA, Aryeetey Y, Akkerdaas JH, et al. Peanut-specific IgE antibodies in asymptomatic Ghanaian children possibly caused by carbohydrate determinant cross- reactivity. J Allergy Clin Immunol 2013;132: 639-47.
7. DuToit G, Roberts G, Sayre PH, Bahnson HT, Radulovic S, Santos AF et al. Randomized trial of peanut consumption in infants at risk for peanut allergy. N Engl J Med 2015; 372:803-813

8. Greer FR, Sicherer SH, Burks AW; Effects of early nutritional interventions on the development of atopic disease in infants and children: the role of maternal dietary restriction, breastfeeding, timing of introduction of complementary foods, and hydrolyzed formulas. Pediatrics 2008: 121: 183-91
9. Muraro A, Halken S, Arshad SH, Beyer K, Dubois AE, Du Toit G, et al. EAACI food allergy and anaphylaxis guidelines. Primary prevention of food allergy. Allergy 2014; 69: 590-601

10. de Silva D, Geromi M, Halken S, Host A, Panesar SS, Muraro A, et al. Primary prevention of food allergy in children and adults: systematic review. Allergy 2014; 69: 581-9
11. Fleischer DM, Spergel JM, Assa’ad AH, Pongracic JA. Primary prevention of allergic diseases through nutritional interventions; J Allergy Clin immunol Pract 2013; 1: 29-36.

12. Chan ES, Cummings C; Canadian Paediatric Society, Community Paediatrics Committee and Allergy Section. Dietary exposures and allergy prevention in high-risk infants: A joint statement with the Canadian Society of Allergy and Clinical Immunology. Paediatr Child Health. 2013;18:545-54
13. Agostoni C, Decsi T, Fewtrell M, Goulet O, Kolacek S, Koletzko B, Et al. Complementary feeding: a commentary by the ESPGHAN committee on nutrition. J Pediatr Gastroenterol Nutr 2008; 46: 99-110

14. Australasian Society of Clinical Immunology and Allergy (ASCIA). [Internet] ASCIA Infant Feeding Advice: Available from URL: http://www.allergy.org.au/images/stories/aer/infobulletins/2010pdf/ASCIA_Infant_Feeding_Advice_2010. pdf. (Accessed April 2, 2015)

Text Box 1: Enrollment Criteria Used in the LEAP Study
Infants considered at “high risk” as defined by the LEAP study criteria:

Egg allergy: Children with either –

1)  a SPT wheal diameter ≥6 mm from exposure to raw hen’s egg white and no history of

previous egg tolerance,

or
2)  a SPT wheal diameter ≥3 mm from exposure to pasteurized hen’s egg white and allergic

symptoms related to exposure to hen’s egg.
Severe eczema: An eczematous rash that –

1)  requires the application of topical creams and/or ointments containing corticosteroids or calcineurin inhibitors, and if the participant is <6 months of age, lasted for at least 12 out of 30 days on two occasions, or if >6 months of age, lasted for at least 12 out of 30 days on two occasions in the last 6 months,

or
2)  is currently or was previously graded ≥ 40 using the modified SCORAD evaluation
Example of method of skin prick testing: used in the LEAP study

• Skin prick test to peanut extract done in the presence of a negative control and a positive histamine control.
• Skin prick testing should be performed in duplicate and the maximum wheal diameter of the two skin prick tests should be calculated and rounded up to the greatest whole millimeter

Of note, in the LEAP trial, the use of IgE measurement to peanut resulted in considerably higher rates of sensitization compared to skin testing, which could lead to numerous unnecessary oral peanut challenges.

Text Box 2: Examples of Peanut-containing Foods Utilized in the LEAP Trial

Smooth peanut butter (2 teaspoons) mixed with milk or with mashed or pureed fruit
*Bamba® snack (Osem; ~2/3’s of 1 oz. (25 g) bag; 21 sticks of Bamba®)

– for young infants (<7 months), softened with 20 – 30 ml water or milk and mixed with milk or with mashed or pureed fruit or vegetables
Peanut soup
Finely ground peanuts mixed into other foods such as yoghurt
(*Other foods more customary to particular nations/cultures may be substituted)

Whole peanut is not recommended for introduction as this is a choking hazard in children under the age of 4.

Asthma and Peanut Allergy

A recent abstract promoted at the American Thoracic Society meeting on the topic of children with asthma being prone to peanut sensitization. The authors suggest children who do have asthma are more likely to be sensitive to peanuts and therefore kids with asthma should be tested for peanut allergy.

This abstract was received with a lot of controversy. If there is no clinical history of peanut allergy in a child that has asthma, no there is no indication to test for peanut allergy, but environmental testing may be helpful. There is no evidence in diagnosing peanut allergy helps treat asthma. Chronic asthma is not a manifestation of peanut allergy or peanut sensitization.

The diagnosis of food allergy results in symptoms of cough, wheezing, hives, swelling, vomiting etc. Without a history of this, food testing is not indicated. These reactions usually occur within 2 hours after ingesting a food, and usually it occurs much sooner. Besides peanuts, the most common food allergies are tree nuts, shellfish, fish, wheat, milk, soy and eggs.

Chronic and poorly uncontrolled asthma is not a result of a hidden food (peanut) allergy. There is no reason to do food allergy testing in these patients unless the clinical history indicates it as above. But asthmatic children who have asthma could benefit from inhalant (environmental testing). i.e. pollen, animal dander, dust mites.

Food allergy testing from a blood test or a skin test is insufficient to diagnose a food allergy. Many patients on food testing show up positive to a food and there is no clinical history after eating the food in question. Positive food testing results should always be interpreted with a clinical history. If a patient has no history of any allergic reactions after eating a certain food, then allergy testing for that food is not necessary.

While children who have food allergy have a higher risk of asthma, and children who have asthma have a higher risk of food allergies, food allergy testing every asthmatic child is not indicated. What is more worthwhile is environmental allergy testing. Many children with asthma are triggered by allergens in the environmental such as trees, grass, weeds, dust mite, molds, dogs and cats. Knowing which inhalant allergens a child is allergic to can help manage asthma.

So in conclusion if your child has asthma it is not necessary to do allergy tests for foods (especially peanut), but allergy testing for inhalant allergens is actually more beneficial. Your local allergy doctor or allergist can perform allergy testing in the office for you.

ORIGINAL TEXT AVAILABLE AT http://allergylosangeles.com

Antibiotics and food allergy induction

The hygiene hypothesis is the most common theory for increased food allergy. It begins with a lack of  early childhood exposure to infections. Without proper stimuli the immune system does not receive necessary education. When presented with food proteins, the normal response (tolerance) is replaced by hypersensitivity.

A recent article, in the early edition of Proceedings of the National Academy of Science*, adds further support for a revised hygiene hypothesis, with emphasis on symbiotic microorganisms living in the gastrointestinal tract. The authors identified a common bacteria found in the gut (aka probiotic) that may prevent development of food allergy, specifically peanut. Much research is needed but here is another potential pathway to a cure for peanut allergy.

clostridia

 

 

* Commensal bacteria protect against food allergen sensitization; Stefka et al.

Food allergy resources

A new diagnosis of food allergy is life-changing. The questions are endless.

I am putting together a new section on the website for parents and patients with food allergy, new and old. I will include links, recipes, diet sheets and school forms.

If you have a valuable resource that you would like to share, please let me know.

Check it out.

What is Eosinophilic Esophagitis?

Eosinophilic esophagitis (EoE) is an inflammatory condition affecting the esophagus (the tube that connects the throat with the stomach). The esophagus contains too high a number of eosinophils, an allergic white blood cell. This causes several gastrointestinal symptoms, including difficulty swallowing, nausea,vomiting and reflux.

Diagnosis: To confirm the diagnosis requires an upper endoscopy and biopsy. Unfortunately, no less invasive procedures are available to diagnose or monitor EoE.

The Role of Allergies: The majority of individuals with EoE have family histories of allergies and symptoms of one or more allergic disorders such as asthma, nasal allergies, atopic dermatitis or food allergy. Food allergy is a major cause of EoE in children, and a less probable factor in adult EoE. Environmental allergies such as dust mites, animals, pollens and molds may also play a role.

Treatment of EE:
– Diet. Avoidance of common allergens (milk, egg, soy, wheat, nuts and fish) may eliminate the symptoms and underlying inflammation of EoE. Atopy patch testing may help to guide food choices.

– Medications. Steroids are effective at shutting down inflammation and eosinophil production. Local delivery helps to lessen side effects. This is achieved by swallowing those steroids indicated for asthma (either a fluticasone inhaler or budesonide for the nebulizer machine).

The initial diagnosis of EoE can be overwhelming. Working closely with your healthcare team is the best way to assure you are receiving proper care. Additionally, families often benefit from participation in support groups, such as the American Partnership for Eosinophilic Disorders (APFED) at www.apfed.org.

Probiotics for the prevention and treatment of allergies

 Probiotics are defined as live microorganisms which when administered in adequate amounts confer a health benefit (FAO/WHO 2002). The potential benefits include inhibition of pathogens, improved integrity of the gastrointestinal (GI) barrier and enhanced immune responses. These effects may be useful for the prevention and treatment of multiple allergic conditions.

Rationale:

– Allergies occur more in developed nations. The hygiene hypothesis states that a highly sanitized environment provides insufficient bacterial stimulation at a young age. Without proper ‘training’ the immune system is unable to distinguish harmful bacteria from healthy foods (tolerance).

– As we get older, the GI associated immune system continues to play an important role. Unfortunately, the composition of gut microbiota can be altered by diet, stress, aging, antibiotics or infection.

– The composition and diversity of intestinal microbiota varies in allergic versus non-allergic children.

– Children born via vaginal delivery are less likely to have allergies than those children born via c-section. Exposure to beneficial bacteria in the maternal vaginal tract helps to colonize the child. Also, this benefit may occur in those children who are  breast fed.

Evidence:

– The effectiveness of probiotics for the prevention and treatment of allergies is controversial. There are a large number of published studies with a wide range of results. Several studies show a great benefit and several studies show no benefit at all.

– The variable results are likely the result of variable protocols. The strain of bacteria, the amount of bacteria and the age of the patient are important factors in determining outcome. It is likely that different strains produce different immunologic effects leading to different outcomes. One probiotic may help asthma and another may help eczema. Examples of beneficial probiotics include, Lactobacillus rhamnosus HN001 and Bifidobacterium longum BB536.

– Eczema (atopic dermatitis). Probiotics have shown value for preventing eczema when given to expecting mothers. Probiotics have shown value for treating eczema when given to young children.

– Allergic rhinitis (sneezing). Several studies from Japan have shown decreased allergy symptoms for patients with tree pollen allergy.

– Food allergy. Infant formulas supplemented with probiotics may improve the symptoms of milk allergic colitis. Unfortunately, supplementation did not accelerate cow’s milk tolerance in those infants with milk allergy.

Conclusion:

Probiotics may be a useful adjunct in the fight against allergic disease. They provide a natural way to stimulate the immune system. Most importantly, proper timing may prevent future allergies. Further research is needed to determine which strains are useful and when they should be taken.

Warning: May Contain Peanuts

labelCurrent treatment options for food allergy are limited. Chinese herbal therapy may prevent reactions. Oral desensitization may one day provide a more permanent cure. Unfortunately, neither treatment is available today. Instead, patients and parents are instructed to avoid a food (or group of foods) without error.

When eating out, you must rely on the kitchen staff. When eating at home, you must rely on the ingredient list provided by the manufacturer. These food labels may be inaccurate or difficult to interpret.

Reading a label is an acquired skill. In order to be successful, parents need to know the benefits and limitations of current labeling laws. Most important is the Food Allergen Labeling and Consumer Protection ACT (FALCPA); passed in 2004 and in effect since 2006. This law requires labels to plainly state, in clear english, if they contain a major food allergen. The major food allergens are milk, egg, fish, crustacean shellfish, peanut, tree nuts, wheat and soy). These ingredients must be listed if they are present in any amount, even in colors, flavors or spice blends. Additionally, the manufacturer must list the specific nut and/or seafood that is used. The food name can be found in one of two places;

1. Within the ingredient list; i.e. “natural flavoring (egg)”.

2. An adjacent “contains” statement; i.e. “Contains egg.” These are usually in bold type.

Passing this law was a step in the right direction. Unfortunately, there remain limitations;

• Only 8 foods groups are required. If you are allergic something else (i.e. sesame seed), it may not be included in the “contains” statement. If you are sensitive to something else (i.e. gluten or preservatives), it will not be included. You must read the full ingredient list.

• Alcoholic beverages, meat, poultry, and certain egg products are not regulated.

• Advisory labels for possible cross contamination are voluntary and inconsistent. Examples include, “May contain traces of peanut,” “Processed on equipment that also processes peanuts,” or “Made in a facility that processes peanuts.”

FALCPA requirements do not apply to potential or unintentional presence of major food allergens in foods resulting from ‘cross-contact’ situations during manufacturing, e.g. because of shared equipment or processing lines. It is left to the discretion of the company if they would like to include a warning statement. The wording of such statements is also left to the company. There are no parameters. This lack of consistency lowers the value of all statements. Their high prevalence and ambiguity leads consumers to doubt their legitimacy. In the end, warning statements are often ignored.

The warning statement is only valuable if can convey the risk of contamination and help parents to make informed decisions. Useful information would include, the probability that the product contains peanut and the amount of peanut that may be present. Several studies have analyzed foods in order to answer these questions. A study from Ireland, looking at 38 food products with a nut statement, found detectable peanut in 5% of foods. The amount of nut protein varied from 0.14 to 0.52 mg per serving (or less than 1/100 of a peanut).  A more recent US study found that 8.6% of foods with a peanut advisory contained a detectable level of peanut protein. Nutrition bars contained the highest levels. Other high risk foods include chocolate candies, cookies and baking mixes.

The problem is not limited to peanuts and tree nuts. In a 2010 study of milk, egg, and peanut; the highest level of contamination was for milk (10.2%). Overall 5.3% of foods with an advisory label were contaminated. The levels of milk found were within the range that may cause a reaction. On the other hand, peanut levels were low. It was estimated that the level of peanut contamination would cause a reaction in only 5% of peanut allergic children, making the overall risk of reaction less than 1%.

The amount of protein that may cause a reaction (threshold) varies dramatically in different children. This makes label standards difficult. The Australian Allergen Bureau have been using investigation and statistics to overcome this obstacle. A Voluntary Incidental Trace Allergen Labeling (VITAL) program was developed to make a single simple standardized precautionary statement available to assist food producers in presenting allergen advice consistently for allergic consumers. VITAL not only assists food producers in assessing the potential impact of allergen cross contact in each of their products but also specifies a particular precautionary allergen statement to be used according to the level of cross contact identified. The initial goal was to label foods with peanut levels higher than 1.5 mg, the amount likely to cause a reaction in 5% of peanut allergic children. With VITAL 2.0, the level drops to 0.2 mg, only 1% of peanut allergic children will react at this level. Additionally, VITAL 2.0 provides manufactures with an action grid containing 24 total foods.

Recommendations that are not specific are not helpful. At this point, the safest course is to avoid any food that declares the major allergen. Parents must read labels ALL of the time. Ingredients can change. In the end, if you are unsure whether or not a product could be contaminated, you should call the manufacturer to ask about their ingredients and manufacturing practices.

Discovery Channel presents “An Emerging Epidemic: Food Allergies in America.”

FARE

FARE (Food Allergy Research & Eductation) has teamed up with The Discovery Channel to produce a new documentary about food allergies called “An Emerging Epidemic: Food Allergies in America.” The hour-long documentary, narrated by Steve Carell, explores what it is like to live with life-threatening food allergies, how families and individuals managing food allergies are working to raise awareness in their communities, and the vital research underway to find effective treatments and a cure.

Watch the full documentary online>

The documentary debuted on Saturday, September 7 and will air again on Saturday, September 21 at 8 a.m. ET/PT. The documentary will also be available for viewing online at www.discoverychannelpatienteducation.com and available for download on iTunes.