introductionintroduction allergic reactions to latex are real. a greater concern is unrealistic...

IntroductionIntroductionIntroductionIntroduction

Allergic Reactions to Latex Are Real.Allergic Reactions to Latex Are Real.

A Greater Concern Is Unrealistic Fear.A Greater Concern Is Unrealistic Fear.The unwarranted fear Is disablingThe unwarranted fear Is disabling

The fear is based on misunderstanding of medical terms The fear is based on misunderstanding of medical terms and continues despite the absence of scientific evidence and continues despite the absence of scientific evidence supporting the fear.supporting the fear.

The Ban Proposed Will Only Serve to Increase The Ban Proposed Will Only Serve to Increase Patients’ Disability From The Unrealistic Fear.Patients’ Disability From The Unrealistic Fear.

Latex as a “Food” AllergenLatex as a “Food” AllergenLatex as a “Food” AllergenLatex as a “Food” Allergen

Allergic reactions have occurred from Allergic reactions have occurred from exposures at work, at home or during exposures at work, at home or during medical examinations or surgery.medical examinations or surgery.

However in 2003 the major problem of allergy to However in 2003 the major problem of allergy to latex is no longer these allergic reactions.latex is no longer these allergic reactions.

It is an unrealistic fear of allergy.It is an unrealistic fear of allergy.

Unrealistic Fear of AllergyUnrealistic Fear of AllergyUnrealistic Fear of AllergyUnrealistic Fear of Allergy

““Health care workers are at the highest risk of a Health care workers are at the highest risk of a clinical allergic emergency from exposure to clinical allergic emergency from exposure to high allergen powdered latex gloves. To our high allergen powdered latex gloves. To our knowledge, no other disease has had greater knowledge, no other disease has had greater direct effect on these providers. With the direct effect on these providers. With the findings that 17% of health care workers in findings that 17% of health care workers in one U.S. hospital were sensitized and 36% of one U.S. hospital were sensitized and 36% of atopic health care workers in one French atopic health care workers in one French study were sensitized, no greater threat exists study were sensitized, no greater threat exists to the careers and potentially the lives of to the careers and potentially the lives of health care workers.”health care workers.”

Kelly, K.J., Walsh-Kelly, C.M., Latex Allergy: A Patient and Health Care System Emergency, Kelly, K.J., Walsh-Kelly, C.M., Latex Allergy: A Patient and Health Care System Emergency, Journal of Journal of

Emergency Nursing, Emergency Nursing, 1998; 24:539A5. 1998; 24:539A5.


““Sensitization” means detectable IgE antibody. Sensitization” means detectable IgE antibody. It does not mean allergic disease. It does not mean allergic disease.

Only about half of individuals with IgE antibody Only about half of individuals with IgE antibody have disease.have disease.

Douglas R, Morton J, Czarny D, O'Hehir RE. Prevalence of IgE-mediated allergy to Douglas R, Morton J, Czarny D, O'Hehir RE. Prevalence of IgE-mediated allergy to latex in hospital nursing staff. latex in hospital nursing staff. Australian & New Zealand Journal of Medicine Australian & New Zealand Journal of Medicine 1997; 27:165-169.1997; 27:165-169.

Meeropol E, Leger R, Frost J. Latex allergy in patients with myelodysplasia and in Meeropol E, Leger R, Frost J. Latex allergy in patients with myelodysplasia and in health care providers: a double jeopardy. health care providers: a double jeopardy. Urologic Nursing Urologic Nursing 1993; 13:34-44.1993; 13:34-44.

Novembre E, Bernardini R, Brizzi I, et al. The prevalence of latex allergy in Novembre E, Bernardini R, Brizzi I, et al. The prevalence of latex allergy in children seen in a university hospital allergy clinic. children seen in a university hospital allergy clinic. European Journal of European Journal of Allergy & Clinical Immunology. Allergy & Clinical Immunology. 1997; 52:101-105.1997; 52:101-105.

Liss GM, Sussman GL, Deal K, et al. Latex allergy: epidemiological study of 1351 Liss GM, Sussman GL, Deal K, et al. Latex allergy: epidemiological study of 1351 hospital workers. hospital workers. Occupadonal & Environmental Medicine Occupadonal & Environmental Medicine 1997; 54:335-342.1997; 54:335-342.

Occupational allergy to latex is actually not as Occupational allergy to latex is actually not as severe as many other occupational allergies.severe as many other occupational allergies.

Of 1258 reported cases of latex allergy in Of 1258 reported cases of latex allergy in hospital staff only two had severe systemic hospital staff only two had severe systemic reactions. None to oral ingestion.reactions. None to oral ingestion.

When the exposure is appropriately When the exposure is appropriately controlled, which does not require complete controlled, which does not require complete removal of latex gloves, health care workers removal of latex gloves, health care workers with allergic disease to latex can work with allergic disease to latex can work without symptoms.without symptoms.



The fear is anaphylaxis. The fear is anaphylaxis.

““Anaphylaxis” is often used ambiguously and Anaphylaxis” is often used ambiguously and imprecisely. imprecisely.

As a consequence the significance of mild As a consequence the significance of mild allergic reactions tends to be overstated.allergic reactions tends to be overstated.

No true anaphylactic reactions have been No true anaphylactic reactions have been reported from oral ingestion of rubber reported from oral ingestion of rubber allergens.allergens.

AnaphylaxisAnaphylaxisDefinitionDefinition

AnaphylaxisAnaphylaxisDefinitionDefinition

Widespread explosive release of mast cell mediators Widespread explosive release of mast cell mediators causing three or more of the followingcausing three or more of the following

• Flush, urticaria, angioedemaFlush, urticaria, angioedema

• HypotensionHypotension

• Airway obstruction, laryngeal and bronchialAirway obstruction, laryngeal and bronchial

• ArrythmiaArrythmia

• Loss of consciousnessLoss of consciousness

• Abdominal pain, diarrhea, vomitingAbdominal pain, diarrhea, vomiting

Ideally confirmed by elevated serum mast cell tryptaseIdeally confirmed by elevated serum mast cell tryptase

Dose-Response ConsiderationsDose-Response ConsiderationsDose-Response ConsiderationsDose-Response Considerations

Allergic reactions occur at the site of contact.Allergic reactions occur at the site of contact.

The severity of an immediate allergic reaction is The severity of an immediate allergic reaction is the result of three variables: the amount of the result of three variables: the amount of allergen, the amount of IgE antibody, and the allergen, the amount of IgE antibody, and the biological response to the mediators from biological response to the mediators from mast cells generated by allergen-antibody mast cells generated by allergen-antibody combination.combination.

Like all biological reactions the dose-response Like all biological reactions the dose-response curve of mast cells to allergens is S shaped.curve of mast cells to allergens is S shaped.

Reactions from trivial amounts of allergen are Reactions from trivial amounts of allergen are trivial.trivial.

Extractable Allergen and Protein Levels in Nonsterile Latex Gloves

10

100

1000

10000

1 10 100 1000 10000 100000

Allergen (AU/ml)

Pro

tein

(m

icro

gra

m/m

l)

Quantitative consideration of transfer of Quantitative consideration of transfer of latex allergens from gloves to food.latex allergens from gloves to food.


There is no scientific evidence There is no scientific evidence demonstrating that a clinicallydemonstrating that a clinically significant amount of allergen can significant amount of allergen can be transferred from a glove to be transferred from a glove to food.food.

The evidence necessary to support The evidence necessary to support the proposed ban, therefore, is the proposed ban, therefore, is not supported by valid science.not supported by valid science.



From a high allergen glove worn inside From a high allergen glove worn inside out transfer was 55 ng per finger out transfer was 55 ng per finger contact. With currently approved contact. With currently approved gloves worn with the antigen carrying gloves worn with the antigen carrying surface inside transfer would be in the surface inside transfer would be in the range of 1 ng per finger contact.range of 1 ng per finger contact.

Beezold DH, Reschkin JE, Allen,JH, Koystal DA, Sussman GL. Beezold DH, Reschkin JE, Allen,JH, Koystal DA, Sussman GL. Latex protein: a hidden “food” allergen? Latex protein: a hidden “food” allergen? Allergy and Asthma Allergy and Asthma ProceedingsProceedings 2000: 21; 301-306. 2000: 21; 301-306.



Assuming that under exceptional Assuming that under exceptional circumstances as much as 10 ng might be circumstances as much as 10 ng might be ingested, the protein allergen is subject to ingested, the protein allergen is subject to degradation by stomach acid and intestinal degradation by stomach acid and intestinal proteases. proteases.

The amount remaining to enter the circulation The amount remaining to enter the circulation is unknown.is unknown.

Assuming half is absorbed it would be diluted Assuming half is absorbed it would be diluted in the blood and body fluids. in the blood and body fluids.

Maximum concentration in the tissues would be Maximum concentration in the tissues would be at the bottom of the S shaped dose-response at the bottom of the S shaped dose-response curve, and not clinically significant.curve, and not clinically significant.

Threshold Doses of Peanut AllergensThreshold Doses of Peanut AllergensThreshold Doses of Peanut AllergensThreshold Doses of Peanut Allergens

• 26 subjects.26 subjects.

• Prospective double blind challenge with increasing Prospective double blind challenge with increasing doses of peanut protein, 30 doses of peanut protein, 30 μg to 1 gm.μg to 1 gm.

• Subjective symptoms of in all 26. (oral allergy Subjective symptoms of in all 26. (oral allergy syndrome) Dose: 100 μg to 1 gm.syndrome) Dose: 100 μg to 1 gm.

• Objective response in 6. No change in FEVObjective response in 6. No change in FEV11 or BP. or BP.– Lip swelling in 3 Dose 0.1 to 10 mgLip swelling in 3 Dose 0.1 to 10 mg

– Laryngeal edema in 2. Dose 0.3-1 mgLaryngeal edema in 2. Dose 0.3-1 mg

– Vomiting in 2 Dose 1 –10 mgVomiting in 2 Dose 1 –10 mg

Wensing et al. The distribution of individual threshold doses eliciting allergic reactions in a Wensing et al. The distribution of individual threshold doses eliciting allergic reactions in a population with peanut allergy. population with peanut allergy. Journal of Allergy and Clinical Immunology 2002;110:915-20Journal of Allergy and Clinical Immunology 2002;110:915-20

Threshold Doses of Food AllergensThreshold Doses of Food AllergensThreshold Doses of Food AllergensThreshold Doses of Food Allergens

Taylor et al. Taylor et al. Journal of Allergy and Clinical Journal of Allergy and Clinical Immunology Immunology 2002;109:24-30.2002;109:24-30.

FOODFOOD DOSE of PROTEINDOSE of PROTEIN

PeanutPeanut 0.2-125 mg0.2-125 mg

EggEgg 0.1-200 mg0.1-200 mg

MilkMilk 0.6-180 mg0.6-180 mg

MustardMustard 0.3 mg0.3 mg

FishFish 5mg-6 gm (Food)5mg-6 gm (Food)

ConclusionsConclusionsConclusionsConclusions

• There is no proof that doses of allergen that There is no proof that doses of allergen that might be transferred from gloves to food might be transferred from gloves to food cause systemic allergic reactions.cause systemic allergic reactions.

• Threshold doses of known allergenic foods Threshold doses of known allergenic foods range from 0.1 to 200 mg. This is of the order range from 0.1 to 200 mg. This is of the order of a thousand fold more than would be of a thousand fold more than would be transferred from gloves.transferred from gloves.

• A ban on rubber gloves in the food industry A ban on rubber gloves in the food industry will fuel the existing unrealistic fear.will fuel the existing unrealistic fear.

introductionintroduction allergic reactions to latex are real. a greater concern is unrealistic...

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