Hypoallergenic Products in India: Making difference in Younger Ones - - PowerPoint PPT Presentation

Hypoallergenic Products in India:

Making difference in Younger One’s Lives.

• Dr. Nandan Joshi

What is Hypoallergenic?

According to the American Academy of Pediatrics (AAP). According to the AAP, a hypoallergenic infant formula must:

• Be studied in a clinical trial
• Be studied in patients with documented cow milk allergy
• Have been shown to be tolerated by at least 90% of the patients

What is Hypoallergenic Infant Formula?

What is special about this date? 2nd November 2016

November 2, 2016 will always be remembered as a landmark date

There has been a dramatic increase in the prevalence of food allergy in the last 10 - 15 years

Adapted from Prescott SL. WAO

What is food allergy?

• Food allergy is an adverse response to an

ingested food or to one of its components that involves the immune system

• Food allergens are almost always

proteins, but not all food proteins are allergens

• Food allergies are a rapidly emerging

public health issue

The top 8 food allergens in children accounting for approximately 90% of all allergic reactions

How do food allergies develop?

Cow’s Milk Protein Allergy peaks in the first year of life with a prevalence of up to 3%

• CMPA is defined as a reproducible adverse reaction

to one or more milk proteins (usually caseins or whey beta-lactoglobulin) mediated by IgE and / or non-IgE-mechanisms

• CMPA peaks in the first year of life with a

prevalence of up to 3%

• In rare cases, exclusively breastfed infants may also

develop clinically significant CMPA via dairy protein transferred into human breast milk9 – The remission rate of CMPA is good with most children (up to 80%) developing a tolerance to cow’s milk by 2 years of age

Acquisition of tolerance to cow's milk during the first two years of age

CMPA in India

Journal of Gastroenterology and Hepatology 2009

Patient Pathway – Financial & Emotional Burden

Initial symptoms stage Self management Final trigger to seek medical help Referral to Paed/Paed gastro

Further Referral

Final Diagnosis & management Outcome of CMPA management Patient follow ups/drop out dynamics Initial Diagnosis & management

Triggers – BM to CM, IF, igE Mediated, few days Home remedies, medication that worked in the past Seek help in days to wks of Symptoms – blood in stools, excessive crying, weight loss, resp symptoms Peds – iGE tests – further

• referal. Elimination diets,

Antibiotics, Antihistamines, Diarrhoea management

~1 month or more

BF, elimination diet + Soy milk, organic eHF & aAFs if Soy Intolerance Primary Outcome – cessation of diarrhoea, vomiting Secondary Outcome – Respiratory, Skin, growth & Development Monthly follow ups uptil 1 yr Drop out rates are frequent

Symptoms of Cow’s Milk Protein Allergy fall into 3 general categories

• CMPA can induce a diverse range of symptoms of variable intensity in infants
• The majority of infants and children with CMPA have ≥ 2 symptoms and symptoms

from ≥ 2 organ systems

Respiratory 20-30% Digestive 50-60% Skin 50-70%

• Rising trend in AD in last 4 decades
• commonest dermatosis registered to pediatric

dermatology clinic

• Urban > Rural [1]
• Mean age of Onset – 3.3 months – 4.2 months

[1]

• Mean Duration of Disease – variable – 3

months to 6 years ISSAC Study – 2.4% - 6% [n - 37000] [3] > 9% [Kerala]

Types of Hypoallergenic formulas

Increased Allergenicity Extensively Hydrolysed formulas Amino Acid formulas

Unique Manufacturing – Only 1 location in the world

No Milk protein allowed in the facility, not even tea or coffee Raw materials are free from allergenic protein. Careful evaluation and testing. Finished product is immunology tested

If not Milk then where do these Amino Acids come from

What has changed after the notification

• The label submission and approval process completed
• Products are now available in India
• It is available at 90+ institutes across India
• And 500+ chemists retailers
• Education and awareness programs are being conducted
• n how to diagnose and manage CMPA

What’s Next

• Maintaining patient registry
• Documenting case studies
• Developing consensus guidelines specific to India for

diagnosis and management of CMPA

• Evolving regulations as new innovations keep coming in this

category