Disparities in Rate, Triggers, and Management in Pediatric and Adult Cases of Suspected Drug-Induced Anaphylaxis in Canada

INTRODUCTION: Data is sparse on drug-induced anaphylaxis (DIA) and there have not been studies assessing the differences in clinical characteristics and management of DIA between adults and children. OBJECTIVE: We assessed the percentage, diagnosis, and management of DIA among all anaphylaxis visits in three pediatric and one adult emergency departments (ED) across Canada. METHODS: Children presenting to the Montreal Children\u27s Hospital (MCH), British Columbia Children\u27s Hospital (BCCH), and Children\u27s Hospital at London Health Sciences Center and adults presenting to Hôpital du Sacré-Coeur with anaphylaxis were recruited as part of the Cross-Canada Anaphylaxis Registry. A standardized data form documenting the reaction and management was completed and patients were followed annually to determine assessment by allergist and use of confirmatory tests. RESULTS: From June 2012 to May 2016, 51 children were recruited from the pediatric centers and 64 adults from the adult center with drug-induced anaphyalxis. More than half the cases were prospectively recruited. The percentage of DIA among all cases of anaphylaxis was similar in all three pediatric centers but higher in the adult center in Montreal. Most reactions in children were triggered by non-antibiotic drugs, and in adults, by antibiotics. The majority of adults and a third of children did not see an allergist after the initial reaction. In those that did see an allergist, diagnosis was established by either a skin test or an oral challenge in less than 20% of cases. CONCLUSIONS: Our results reveal disparities in rate, culprit, and management of DIA in children versus adults. Further, most cases of suspected drug allergy are not appropriately diagnosed. Guidelines to improve assessment and diagnosis of DIA are required

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013 . S tatement on the safety of ' Cetyl Myristoleate Complex ' as an ingredient in food supplements

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to update its opinion on the safety of ‘Cetyl Myristoleate Complex’ (CMC) as a novel food ingredient in the light of a new repeated dose 90-day oral toxicity study in mice. In its previous opinion of 2010, the Panel concluded that based on the available data, the safety of CMC as an ingredient in food supplements has not been established. This conclusion was based on the considerations that in the absence of appropriate data on absorption, distribution, metabolism and excretion, the provided toxicological data were insufficient. Whereas the applicant considers that the NOAEL of CMC in this new 90-day study was 1000 mg/kg body weight (bw), the highest dose tested, the Panel considers that this study and study report has many shortcomings to be a reliable source of information supporting the absence of adverse effects of the parent material CMC. The Panel concludes that the safety of 'Cetyl Myristoleate Complex' has not been established

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific Opinion on the substantiation of a health claim related to “non - fermentable ” carbohydrates and maintenance of tooth mineralisation by decreasing tooth demineralisation pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Roquette Frères, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Nutriose® which should replace “fermentable carbohydrates” in foods or beverages in order to obtain the claimed effect, i.e. maintenance of tooth mineralisation by reducing tooth demineralisation. From the information provided, the Panel noted that the main characteristic of carbohydrates which is relevant to the claimed effect is the rate and amount of acid production resulting from their fermentation by saccharolytic bacteria in the oral cavity. This Opinion applies to “non-fermentable” carbohydrates, which should replace “fermentable” carbohydrates in foods or beverages in order to obtain the claimed effect. The Panel considers that maintaining tooth mineralisation by reducing tooth demineralisation resulting from acid production in plaque caused by the fermentation of carbohydrates is a beneficial physiological effect. The Panel concludes that a cause and effect relationship has been established between the consumption of foods/beverages containing “fermentable” carbohydrates at an exposure frequency of four or more times daily and an increased tooth demineralisation, and that the consumption of foods/beverages containing “non-fermentable” carbohydrates instead of “fermentable” carbohydrates may maintain tooth mineralisation by decreasing tooth demineralisation. In order to bear the claim, “fermentable” carbohydrates should be replaced in foods or beverages by “non-fermentable” carbohydrates, so that consumption of such foods or beverages does not lower plaque pH below 5.7 during and up to 30 minutes after consumption, and does not lead to dental erosion

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to E<em>ff</em>_EXT™ and maintenance of normal joint mobility pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to EffEXT™ and maintenance of normal joint mobility. The Panel considers that EffEXT™, which is standardised pure krill oil, is sufficiently characterised. The claimed effect proposed by the applicant is “contributes to support joint flexibility”. The Panel considers that maintenance of normal joint mobility is a beneficial physiological effect. The applicant identified one human intervention study as being pertinent to the health claim. The Panel notes that chronic inflammation was an inclusion criterion of the study, that a significant number of the patients recruited were reported to have confirmed diagnosis of osteoarthritis, rheumatoid arthritis, or of both cardiovascular disease and osteoarthritis, and that the WOMAC osteoarthritis questionnaire was administered only to patients with arthritic disease (osteoarthritis or rheumatoid arthritis). The Panel also notes that no evidence which could justify the extrapolation of the results, obtained in patients with joint diseases characterised by chronic inflammation, to the target population, subjects without chronic joint diseases, was provided by the applicant. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of EffEXT™ and maintenance of normal joint mobility

Scientific opinion on health benefits of seafood (fish and shellfish) consumption in relation to health risks associated with exposure to methylmercury

Following a request from the European Commission to address the risks and benefits as regards fish/seafood consumption related to relevant beneficial substances (e.g. nutrients such as n-3 long-chain polyunsaturated fatty acids) and the contaminant methylmercury, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a Scientific Opinion on health benefits of seafood consumption in relation to health risks associated with exposure to methylmercury. In the present Opinion, the NDA Panel has reviewed the role of seafood in European diets and evaluated the beneficial effects of seafood consumption in relation to health outcomes and population subgroups that have been identified by the FAO/WHO Joint Expert Consultation on the Risks and Benefits of Fish Consumption and/or the EFSA Panel on Contaminants in the context of a risk assessment related to the presence of mercury and methylmercury in food as relevant for the assessment. These included the effects of seafood consumption during pregnancy on functional outcomes of children\u2019s neurodevelopment and the effects of seafood consumption on cardiovascular disease risk in adults. The Panel concluded that consumption of about 1-2 servings of seafood per week and up to 3-4 servings per week during pregnancy has been associated with better functional outcomes of neurodevelopment in children compared to no consumption of seafood. Such amounts have also been associated with a lower risk of coronary heart disease mortality in adults and are compatible with current intakes and recommendations in most of the European countries considered. These associations refer to seafood per se and include beneficial and adverse effects of nutrients and non-nutrients (i.e. including contaminants such as methylmercury) contained in seafood. No additional benefits on neurodevelopmental outcomes and no benefit on coronary heart disease mortality risk might be expected at higher intakes