The US Food and Drug Administration (FDA) first alerted healthcare professionals (HCPs) about a possible association between the use of leukotriene inhibitors and neuropsychiatric events in 2008 and added information to product labels in 2009. The reported events included agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. While the precaution was extended to all agents in this class, particular concern has been raised about montelukast due to its widespread use in both adult and pediatric patients for multiple indications. Montelukast is approved for the chronic treatment of asthma, acute prevention of exercise-induced bronchial constriction, and relief of both perennial and seasonal allergic rhinitis symptoms. Singulair is approved in adults and children 6 months of age and older. Continued concerns about suicidality and neuropsychiatric events with montelukast were again raised at a recent FDA Pediatric Advisory Committee (PAC) meeting in September 2014. Medscape spoke with Sally Seymour, MD, and Erika Torjusen, MD, MHS, both at the Center for Drug Evaluation and Research in the Division of Pulmonary, Allergy, and Rheumatology at the FDA, about the advisory committee meeting, concerns with these agents, and the implications for HCPs.
Medscape: Can you briefly review the concerns presented at the advisory committee meeting about these agents?
Dr Seymour: On September 23, 2014, montelukast was discussed at the PAC meeting as part of a routine pediatric safety review.It was noted that
despite the FDA’s communication efforts and information in the product label, many physicians are not aware or do not communicate the risk for neuropsychiatric events to patients.
As part of the discussion, the committee reviewed the current montelukast labeling regarding the risk for neuropsychiatric events. Members wanted health care provider to be cognizant of the association with neuropsychiatric events and consider discontinuing montelukast if they occur.
• In the last decade, the cases of food allergies have doubled and the number of hospitalisations caused by severe allergic reactions has increased 7-fold
• More awareness and education is needed to improve management of food allergies and anaphylaxis
– With more than million are suffering from allergies, food allergy is one of the most common allergic diseases. As the prevalence of food allergy is greater among children than adults, food allergy has been recognised as a major paediatric health problem in western countries. The number of hospital admissions for severe allergic reaction in children has increased 7-fold in the past 10 years .
“Food allergy is not a trivial disease. No cure has been found yet and the disease is so unpredictable that it often causes anxiety in patients and caregivers, leading to social exclusion because of the fear of eating dangerous foods by mistake. Only clear information on ingredients and disease management can help food allergy patients”.
Food allergy is a major public health problem: governments and the general public are expected to face increasing direct and indirect costs, due to its major effects on lifestyle and quality of life.
the increasing incidence and burden of food allergy and of severe allergic reactions such as anaphylaxis and calls on patients, healthcare professionals and pharmacists to familiarise themselves how to recognise early and manage these diseases.
“By focusing on education for food allergy prevention, early diagnosis and correct management, EAACI hopes to help patients and their families to better control their food allergy and improve their quality of life and to increase the resources allocated by the society to manage the allergy epidemic”, to translate best science into best practice.
Prompt recognition and management of severe allergic reactions are of utmost importance as such reactions can be fatal. Caregivers, teachers and parents should be provided with information on how to manage severe allergic reactions, including adrenaline auto-injectors and instructions on how and when to use it. It is crucial to better inform schools and restaurants staff so they can help patients avoid accidental exposure and make appropriate food choices.
Anaphylaxis is a severe generalised or systemic hypersensitivity reaction that is potentially fatal . It is characterised by its rapid onset and triggering respiratory or circulatory problems, generally associated to changes in the skin and mucous membranes. Food, medicines and insect stings are the three most important causes of anaphylaxis. In children, food is the most common cause. Drugs and hymenoptera venom are the most common causes of anaphylaxis in adults. Although considerably under-diagnosed, the epidemiological figures show an incidence rate of anaphylaxis in Europe ranging from 1.5 to 8 per 100,000 people/year, with an increase in cases of anaphylaxis in the last twenty years.
food allergy can be life threatning,even aeroallergens can cause anaphylaxis.so initially patient may have other allergy symptoms as allergic rhinitis,atopy,asthma,skin allergy,gastrointestinal disturbances as acidity,indigestion,diarroea etc,later anytime child can have severe anaphylaxis reactions.HOPE meeting(handling of paediatric office emergencies) ,as National faculty at IAP (Indian acdemy of paediatrics) at banaglore proper management as allergy teating,De-sensitisation (immunotherapy ) can be life saving
Swine flu(H1N1) infection is like a viral infection,but spreads fast or makes seroius to those with underlying susceptibility as allergic rhintis,asthma,COPD,diabetes,hypertension,any chronic diseases.Not only H1 N1(Swine flu) other as Dengue,malaria,Typhoid infections spread fast in these allergic patients.So identifying early allery with alergic tetsing ,Immunotherapy really helps to improve quality of life,less complications in terms of pneumonias,cardiac etc.
Considering incraeasing population,pollution,adulteration (food allergy,low immunity causing food,pesticides.allergy manegement is very important in Today’s life,lots of myths about allergy testing can be reduced with proper autheticated skin modified technique with no false positive results,cost effective ,less painful,bloodless testing,.;Sublingual immunotherapy really helps to reduce the symptoms and long term complications
Yesterday I had a patient for follow up from a village ahead of Nipani junction on Goa road 23 yr with allergy as allergic rhintis,bronchitis ,significant Eye allergy since 8 yrs,he was on repeted steroids eye drops intermittently,had underwent cataract surgery,Glaucoma surgery both surgeries within a period of two years,after allergy testing and Immunotherapy 50% improvement within one month,last 4 moths is off steroids eye drops,without allergic rhintis(not disclosing his video,or name as he is young and he requested not to disclose it.Allergy test for any allergy with immunotherapy helps alot to patients with thousands of such dramatic improvements with lessening of inhaled steroids(nasal sprays,inhalers,oral stroids ) to patients of skin allergy(urticaria,drmatitis),asthma,deviated nasal septum,snoring,repeated respiratory ,throat infection,cough,sinusitis ,migraine patients,even food intolerance as acidity,irritable bowel syndrome indigestion,ulcerative colitis,gastro-colic reflux,food anaphylaxis is increasing a lot.
Long term complication as asthma,COPD can be prevented,after few years even all medications for asthma,allergy can be stopped(referrence Respimirror issue May 2014 By Chest research foundation)
H1N1(Swine flu presents as any other viral infection only,or common flu like symptoms only,some of the patients it spreads fast with severe symptoms of cough,throat congestion,breathlessness,high grade fever,bodyache,headache,giddiness,weakness,vomiting,diarroea etc.
It affects seriously in patients having low immunity,underlying chronic diseases as diabetes,allergy,asthma,COPD,hypertension,on steroids for chronic diseases.Now a days most of the patients have allergy,low immunity because of life style,pesticides on fruits,on vegetables,cold-drinks,preservatives in foods;it inturn affects immunity.
To increase immunity exercise,proper balanced Diet,lots of fruits,vegetable(organic farming),water intake,rest is necessary.Along with it as allergy specialist,immunologist we regularly prescribe immunomodulators,medicines to increase immunity,so that severity of infection is less,and it prevents on flu like infections.
The medicines to increase immunity very from children,adults with detailed history of patient,safe,mostly ayurvedic medicines which are prescribed one regularly,and studies have shown the results for increasing immunity
H1N1 infection(swine flu) is influenza virus infection ,as common flu it may affect a person as a regular viral infection,Most of the patients which have complications,as ARDS,Pneumonia,septicaemia,disseminated infection,death with person having Underlying diabetes,Hypertension,Allergy,allergic rhintis,asthma,COPD,immunocomprised patients.
As allergy is third chronic disease in India even amongst children,these patients with primary allergy,has to do allergy testing,De-sensitisation(imunotherapy),so that their immunity incareses ,less complications because of secondary infections as Swine flu,or similar fast spreading infections.
At present during epidemics,people can have Colostrum,regular exercise,good sleep,breathing exercises,healthy,balanced diet,fruits etc.
Last 14 years visiting Rural pune district as nasarpur,Bhor,velha,panshet areas regularly,doing spirometry,allergic testin of patients from infancy to adults.Lots of cases have gone up of skin,respiratory allergies,as dust,exhausts from vehicle,changing diet as fast foods,chocolates ,bread intake has increased,urban type life style is causing more harm.
health awareness is lacking,burning woods for fire,clothes are kept any where,pesticides are having big problem as pollen allergy is very comon
As as per world standards whatever respirable,permissible air quality is expected,In delhi pollution is more than 10 times,as compared to Indian permissible limits Delhi pollution is 4 times.In Pune as per Indian std. pollution in air is 2 times.
These polluted particles ,they stimulate the turbinates as well oral mouth breathers in allergic rhinitis,as well during snoring(OSA) patients as patients directly inspire polluted particles they deposit in lungs ,specifically in children as their lungs are in developmental stage they may have lot of changes and long term harm to lungs.