Latex allergy: Management

Official reprint from UpToDate® www.uptodate.com

©2024 UpToDate®

Latex allergy: Management

Author: Robert G Hamilton, PhD, DABMLI, FAAAAI
Section Editor: Bruce S Bochner, MD
Deputy Editor: Elizabeth TePas, MD, MS

Contributor Disclosures

All topics are updated as new evidence becomes available and our peer review process is complete.

Literature review current through: Feb 2024. | This topic last updated: Sep 26, 2023.

INTRODUCTION

Natural rubber latex (NRL) allergy is caused by sensitization to proteins in the sap-like fluid
(latex) from the commercial rubber tree, Hevea brasiliensis (Hev b). Most patients are
sensitized through exposure to NRL gloves or other dipped latex products (eg, dental dams,
condoms, and balloons) in a medical or occupational setting.

Since its first identification as a concern in the 1980s, the mainstay of management of latex
allergy has been avoidance of latex products. Several other therapeutic approaches have
been under investigation, including symptomatic pharmacotherapy, immunotherapy (IT), and
anti-immunoglobulin E (IgE) therapy, but they have not shown promise.

The management of latex allergy, including avoidance measures and experimental therapies
that have been attempted, are reviewed here. Due to increase demand for locally produced
personal protective equipment (including disposable gloves) as a result of the worldwide
coronavirus disease 2019 (COVID-19) pandemic and other factors related to disposal issues,
biodegradable properties, and climate change discussed in this review, it may be time to
reconsider the use of a new generation of low-protein NRL medical gloves that meet rigorous
performance and safety standards. An overview of latex processing and latex allergens and
review of the epidemiology, clinical manifestations, and diagnosis of latex allergy are
discussed separately. (See "Latex allergy: Epidemiology, clinical manifestations, and
diagnosis".)
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Latex allergy: Management

OVERVIEW

Types of allergic reactions — Latex allergy can involve delayed (type IV) or immediate type I
reactions. Persons with delayed hypersensitivity that is manifested as a contact dermatitis
associated with accelerator chemical sensitization are at increased risk for developing IgE-
mediated (type I) systemic reactions. Thus, all persons with latex sensitivity, as documented
by a positive Hevea latex-specific IgE antibody response, should be managed similarly.

Strategies for preventing or managing latex allergy — There are four possible strategies
for preventing or managing allergic symptoms once a person is diagnosed with latex allergy:
● Avoidance – The most effective and least expensive method is avoidance of natural
rubber latex (NRL) allergen exposure [1-4]. The prevalence of latex allergy among health
care workers and the general public has dropped dramatically and, in some locations, to
undetectable levels due to widespread avoidance measures involving a practical "latex-
safe" (not "latex-free") environment strategy that has been adopted by most medical,
dental, and nursing home facilities. (See 'Institutional avoidance' below and "Latex
allergy: Epidemiology, clinical manifestations, and diagnosis", section on
'Epidemiology'.)
● Pharmacotherapy – The treatment of acute and chronic allergic symptoms with
pharmacotherapy is possible. However, prevention of reactions and the possibility of
increased sensitization are preferred. Unfortunately, preventive pharmacotherapy is
rarely effective.
● Immunotherapy (IT) – The use of IT is limited due to the unavailability of approved
therapeutic NRL extracts and a high frequency of adverse reactions when experimental
extracts were used [2,5,6]. (See 'Immunotherapy' below.)
● Anti-IgE therapy – Anti-IgE therapy is under investigation for use in patients with IgE-
mediated latex allergy as an off-label indication [7,8]. Anti-IgE is sometimes used
together with an IT regimen. It is costly, and patients must have the appropriate body
weight and total serum IgE level between 30 and 700 kU/L to be a candidate for
omalizumab treatment.

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Latex allergy: Management

INSTITUTIONAL AVOIDANCE

Latex free versus latex safe — There is a general misconception that a "latex-free"
environment means one totally devoid of natural rubber latex (NRL) products. It conceptually
remains a requirement to establish a safe environment for patients and employees who are
sensitized (IgE antibody positive) to NRL allergens. A completely NRL-free environment is not
practically achievable. In contrast, effective institutional avoidance of latex allergen has been
accomplished by establishing a latex-safe environment that involves recognizing the
importance of controlling latex allergen exposure for health care workers, the general public,
and, more specifically, persons with NRL allergy.

Latex advisory committees — Most medical institutions established a latex committee and
an institutional program to eliminate NRL allergen exposure [3,9-11]. A multidisciplinary latex
advisory committee typically has been composed of local experts with knowledge in legal
matters, purchasing, occupational safety, allergy, and glove use, including surgery, medicine,
and anesthesiology [1,9,12,13]. While institutional latex advisory committees still exist on
paper, most have not met in years because of the decline of latex allergy prevalence. Latex
allergy has essentially disappeared from the general conscience of the medical and dental
communities.

Latex-safe environmental policies — Establishment of latex-safe environmental policies

involves replacing Hevea latex-containing products with non-Hevea-based synthetic products,
if possible, or, at a minimum, identifying NRL products that do not release large quantities of
latex allergen, such as powder-free latex gloves. Powder-free NRL products generally undergo
extensive additional washes and a final chlorination step that removes Hevea-allergenic
protein. (See 'NRL product and environmental monitoring' below.)

Medical/surgical gloves — The primary source of Hevea latex exposure in medical

institutions in the 1980 to 2010 period was the powdered medical examination/surgical glove
(both nonsterile and sterile gloves) [3,14,15]. The level of allergenic protein released from
latex gloves can be determined [16-18]. Some institutions have globally converted only their
examination gloves to synthetic alternatives because examination gloves have higher NRL
content than surgical gloves, while others have transitioned completely to non-Hevea gloves
[4,9,11,13,19]. A small number of institutions have created a latex-"safer" environment by
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Latex allergy: Management

replacing all powdered latex gloves with low-allergen-containing, powder-free latex gloves
that are less allergenic [20].

It may be time to more broadly reconsider the use of particular NRL gloves that are
documented to release low or no latex-allergenic protein based upon analytical
documentation along with synthetic medical gloves, a particularly relevant consideration with
increased glove demands during the coronavirus disease 2019 (COVID-19) pandemic.
However, there is no universally accepted criterion, such as the use of <0.15 mcg/g of glove of
summed Hev b 1, 3, 5, and 6.02 allergens [21], that has been adopted by manufacturers or
regulators for defining a glove as having a low allergenic potential, although it is under
consideration. In addition, the question remains whether a "lot" or "batch" of NRL gloves
manufactured on a production line can be shown to have <0.15 mcg/g of glove of summed
Hev b allergen at the beginning, middle, and end of a run of thousands of gloves. (See 'NRL
product and environmental monitoring' below.)

Hevea rubber stoppers (closures) have been the subject of intense debate. We and
others have shown that puncturing a 100 percent NRL pharmaceutical vial closure can
release low amounts of Hevea proteins into the pharmaceutical vial contents [22]. The
levels of allergen are low, can be detected by skin testing, and increase with each
puncture. Due to this observation, pharmaceutical companies have mostly eliminated
the concern by switching to the use of synthetic butyl rubber stoppers that contain no
Hevea proteins. If there is a question by a pharmacist whether a particular vial contains
a Hevea protein-containing latex stopper, they are encouraged to use the "one stick rule"
that we have demonstrated provides the safest protocol for the administration of a
pharmaceutical after puncturing through a Hevea latex stopper [23]. For highly latex-
allergic persons, injection of a drug containing Hevea proteins can evoke an allergic
response, especially if administered intravenously. Thus, careful avoidance throughout
their life is encouraged since chronic reexposure will lead to resensitization. The low
levels of Hevea latex released by puncturing a 100 percent NLR are, however, not
considered a concern for eliciting de novo sensitization in an otherwise non-latex-
allergic person.

High-risk health care workers and sensitized patients — For high-risk health care workers
and sensitized patients, latex avoidance is critically important to reduce symptoms and

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Latex allergy: Management

further sensitization. Institutions that have an employee with latex allergy must adhere to
strict policies. At a minimum, such policies should permit only the use of low-protein, powder-
free latex products for all employees and latex-free products for sensitized persons. It is not
acceptable to give special latex-free gloves only to the worker with latex allergy since their
environment can endanger them if a coworker inadvertently uses Hevea allergen-rich gloves.
Use of low-protein, powder-free latex gloves by coworkers decreases, but does not eliminate,
symptoms in health care workers with latex allergy [24].

NRL product and environmental monitoring — Measuring the release of Hevea allergens
from various products ( table 1), particularly medical gloves, and airborne levels of these
allergens in occupational settings, is critical to documenting the suitability of newer-
generation low-protein natural rubber latex (NRL) medical gloves in a latex-safe work
environments. This determination can be used to document that an institution has
transitioned to latex-safe status.

ASTM International (formerly the American Society for Testing Materials) has qualified
three standardized assays for evaluating the relative safety of Hevea latex-containing
products and aeroallergen environmental monitoring where Hevea latex products are used.
Of these three assays, the immunoenzymetric assay (IEMA; ASTM D7427-08) is preferred
because its results are most predictive of a product's latex "allergen" content. Other assays
for Hevea allergens, such as the human IgE anti-latex-based competitive inhibition assay [25],
remain research tools in selected laboratories due to their requirement for large amounts of
human IgE anti-latex-containing serum [26].
● Hevea allergens – Of the 15 known Hevea allergens [27], H. brasiliensis (Hev b) 1, 3, 5,
and 6.02 have been identified as the principal "indicator" allergens for monitoring
products and environments ( table 2) [28,29] (see "Latex allergy: Epidemiology, clinical
manifestations, and diagnosis", section on 'Hevea indicator allergens'). Two-site
monoclonal antibody-based IEMAs (ASTM D7427-08) are established as standard
methods that provide quantitative estimates of these indicator allergens in product
extracts and environmental samples [26,30]. The sum of the Hev b 1, 3, 5, and 6.02
content in physiologic extracts reflects the allergenic potential of a Hevea latex-
containing product or environment [21]. Quantification of Hev b 1 and Hevamine alone
is insufficient to effectively assess rubber product allergen potency [31]. Summed

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Latex allergy: Management

concentrations of Hev b 1, 3, 5, and 6.02 totaling <0.15 mcg/g of glove were shown to
have low allergenic potential as assessed independently by an IgE enzyme-linked
immunosorbent assay (ELISA) inhibition assay [21].

An earlier study using an IgE antibody-based inhibition assay has suggested that a latex
aeroallergen threshold of 0.5 nanograms/cubic meter of air indicates a safer work
environment [32]. However, threshold environmental determinations have not been
qualified using the ASTM D7427-08 IEMAs for allergen content.
● Hevea antigens – Hevea proteins that elicit an antibody response can be detected with
the ASTM D6499 antigen ELISA [33,34]. The utility of this measurement depends on the
ability of all Hevea allergenic proteins to elicit an antibody response that is detectable by
the assay. Its major limitation is that it does not distinguish between latex allergens (IgE
inducing) and nonallergenic antigens (non-IgE inducing), and, therefore, it only provides
an indirect measure of the allergenic potential of a product or environment. Like the
total protein assay, the Hevea antigen assay is not suitable for definitively identifying
"latex-safe" products and environments that require the assessment of accurate
allergen content.
● Total protein – The modified Lowry test (ASTM D5712) was the first assay developed to
monitor total Hevea protein in product extracts or environmental specimens [33,35].
This assay, while the least expensive of the three tests, is the least useful for defining
levels of Hevea allergenic protein as it has limited analytic sensitivity and is only able to
quantify high levels of total extractable protein and does not discriminate between
allergenic and nonallergenic Hevea proteins.

Hevea latex alternatives — Synthetic elastomers and a non-Hevea rubber (Yulex) have been
developed for use as alternatives in the manufacturing of commercial "rubber-like" products:
● The most common synthetic elastomers include butyl rubber, a completely petroleum-
based product with no allergenic protein, polymers of 2-chlorobutadiene (neoprene),
and copolymers of butadiene and acrylonitrile [36]. The predominant nonsterile,
nonlatex examination gloves used in medical institutions today are made of nitrile,
neoprene, vinyl, or synthetic polyisoprene rubber that is extracted from oil. Their color
(white, blue, purple, or green) is arbitrary and does not reflect the type of material in the
glove. Different glove materials vary in terms of their ability to be sterilized and still
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Latex allergy: Management

maintain their barrier properties.

● Historically, a non-Hevea source of natural rubber is the Guayule plant (Parthenium
argentatum) [37,38]. The raw material extracted from the shrub has an ultra-low protein
content. The proteins that are present display no apparent in vitro or in vivo cross-
reactivity with Hevea latex allergens. Thus, Yulex-based rubber products should pose no
risk to persons who are allergic to Hevea latex. In the United States, some Yulex-based
products were cleared by the US Food and Drug Administration (FDA). As of 2021, the
company making Guayale products converted from using Parthenium to low-protein
Hevea latex from Central American sources to manufacture consumer products (eg, wet
suits) and, in the future, medical gloves.

INDIVIDUAL AVOIDANCE

General approach — All persons with latex allergy, whether or not they come in contact with
potentially contaminated body fluids, should use only non-Hevea medical gloves. In addition
to gloves, there are as many as 40,000 consumer products in home and medical/dental
environments that may contain natural rubber latex (NRL) [39,40]. Examples are listed in the
table ( table 1). Latex-containing forms of these products should be avoided as well. In the
United States, Hevea latex-containing medical devices must be labeled "containing natural
rubber latex" with a medical alert boxed warning. Unfortunately, there is no requirement for
companies to label rubber products with their latex protein content. Consumer products do
not have the same stringent labeling requirement. However, many are labeled as containing
latex, which refers to NRL.

Duration of avoidance and reevaluation in persons with latex allergy — It is well

established that employing a latex-safe environment in an institution leads to a decrease in
latex-induced symptoms and reported employee and patient sensitivity. However, latex-
specific IgE antibody can remain detectable for at least five years in the skin and blood of
persons with latex allergy who avoid latex exposure [3,4,11,25,41-43]. Thus, continued
avoidance of allergen exposure is recommended. (See 'Strategies for preventing or managing
latex allergy' above.)

Reevaluation, principally by IgE anti-NRL serology assays, to assess continued sensitization is

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performed primarily for information since a previously sensitized person is at risk for
resensitization. Thus, latex allergen avoidance precautions should still be followed even if
subsequent serologic testing is negative. However, a negative repeat IgE anti-NRL serology
analysis is comforting as it suggests that the potential for an allergic response resulting from
an inadvertent latex allergen exposure is minimal.

Repeat evaluations are typically performed just prior to a required medical or dental
procedure to assess risk or during a yearly health checkup. IgE anti-latex serology is the only
available evaluation test available in the US due to its well-documented inter-assay latex
allergosorbent consistency and its ability to generate a semiquantitative (kUa/L) result. In vivo
skin test methods are not available in the US, due to an absence of approved NRL skin test
extracts. European medical institutions, in contrast, can perform both serology and puncture
skin testing because of the availability of at least one well-characterized approved NRL
extract.

ADDITIONAL MANAGEMENT ISSUES

Workplace — A systematic approach for managing a worker with suspected natural rubber
latex (NRL) allergy begins with confirmation of the diagnosis of latex allergy using validated
diagnostic methods [1,12,19]. In the US, this is an IgE antibody analysis by one of several US
Food and Drug Administration (FDA) cleared immunoassay auto-analyzers. In Europe, it can
also involve the use of an NRL extract-based puncture skin test. Confirmation of latex
sensitization can justify efforts put forth for cessation of further NRL exposure in the patient's
workplace. (See "Latex allergy: Epidemiology, clinical manifestations, and diagnosis", section
on 'Objective tests to demonstrate latex allergy'.)

Despite the extensive research on the diagnostic potential of the 15 well-characterized Hevea
latex allergenic components, IgE antibody measurements specific for these individual latex
allergen components do not increase diagnostic sensitivity for latex-driven occupational
asthma compared with just detecting IgE antibody to the natural extract [44]. IgE anti-latex
component measurements do, however, aid in discriminating between different routes of
latex allergen exposure (eg, inhalation [Hev b 5/6.02] versus mucosal contact [Hev b 1/3]).

One must document that impairment and disability results from latex exposure in the
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Latex allergy: Management

workplace. The employer then needs to be educated about the patient's diagnosis and their
responsibility to provide effective interventions to create a latex-safe environment. If the
patient cannot be effectively accommodated, workers' compensation benefits and
rehabilitation may be appropriate.

Schools — A systematic approach for managing a confirmed NRL allergy in a student in a

school program begins with development of an individualized health care plan and a
schoolwide avoidance plan. Education of the student on self-management skills is vital if the
child has a risk of anaphylaxis [45].

Individuals — Several measures for the person with latex allergy are recommended to
prevent and manage allergic reactions [39,46]:
● A medical alert bracelet indicating latex allergy should be worn.
● Self-injectable epinephrine should be prescribed for all persons with a clinical history of
systemic reactions to latex. (See "Prescribing epinephrine for anaphylaxis self-
treatment" and "Anaphylaxis: Emergency treatment", section on 'Epinephrine'.)
● Nonlatex gloves should be carried.
● Patients should report their allergy prior to any medical, dental, gynecologic, or surgical
procedure and request a latex-safe environment [47]. (See "Perioperative anaphylaxis:
Evaluation and prevention of recurrent reactions", section on 'Latex'.)

Immunotherapy — The use of immunotherapy (IT) for the treatment of IgE-mediated latex
allergy is limited by the absence of regulator-approved extracts and the frequency and
severity of reactions to IT [5].

Several small, randomized trials were performed with conventional subcutaneous

immunotherapy (SCIT) using crude latex extracts [48-50]. Efficacy was variable. One trial
demonstrated decreased symptoms of urticaria and rhinoconjunctivitis but not asthma [48],
whereas another did show reduced airway hyperreactivity to latex [49]. A third trial failed to
demonstrate any difference in medication use or symptom scores [50]. A high frequency of
adverse events, including systemic reactions, was reported in all studies. In one trial, adverse
events occurred with similar frequency in both the induction and maintenance phases of the
regimen [48].

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Latex allergy: Management

Some studies suggest that the frequency and severity of adverse events are lower with
sublingual immunotherapy (SLIT) compared with SCIT [51-55]. However, results vary, and
anaphylaxis has been reported with SLIT [56-59].

Novel IT approaches are under investigation to decrease the risk of severe adverse reactions
(allergenicity) and yet maintain or improve efficacy (immunogenicity). These approaches
include recombinant allergens, T cell epitope-based peptides, and adjuvants that are
conjugated to or coadministered with the allergen [39,60]. These therapies are still in the
experimental stages.

SOCIETY GUIDELINE LINKS

Links to society and government-sponsored guidelines from selected countries and regions
around the world are provided separately. (See "Society guideline links: Latex allergy".)

SUMMARY AND RECOMMENDATIONS

● Avoidance – Once latex allergy is diagnosed, avoidance should be instituted as the

primary method of management. Pharmacotherapy, immunotherapy (IT), and anti-
immunoglobulin E (IgE) therapy are not substitutes for effective avoidance. (See
'Overview' above and 'Immunotherapy' above.)
● Institutional strategies – Institutional policy changes in the use of Hevea products can
reduce occupational and patient exposures. One approach is to use the "one stick rule"
for a patient who is highly allergic to latex when administering a pharmaceutical after
puncturing through a Hevea latex stopper or when the stopper material is not known.
Another is a universal criterion for insuring low allergenic potential of low-protein
powder-free natural rubber latex (NRL) medical gloves. Once this is adopted by glove
manufacturers and accepted by governmental regulators (eg, <0.15 mcg per gram of
glove of summed Hev b 1, 3, 5, and 6.02 allergens), it may be time to reconsider the
reinstitution of these low-allergen NRL gloves back into institutions that have historically
had a NRL-free policy. (See 'Institutional avoidance' above.)
● Individual strategies – Nonlatex-containing gloves should be used by persons with
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Latex allergy: Management

latex allergy who use protective gloves. In addition, use of low-powder latex gloves by
coworkers decreases exposure and sufficiently decreases symptoms in the person with
latex allergy in most cases. The policy of using of nonlatex gloves by all is poised to
change once qualified low-allergen, low-protein, powder-free NRL gloves become
available. Other latex-containing products should also be avoided. (See 'Individual
avoidance' above.)
● Assessment of NRL allergens in products and the environment – Standardized assay
methods for the quantification of allergenic Hevea proteins facilitate differentiating
between highly allergenic Hevea-containing products and occupational environments
and those with low allergenic potential. (See 'NRL product and environmental
monitoring' above.)
● Hevea latex alternatives – Synthetics are alternative products are considered safe for
use in Hevea-sensitized individuals. (See 'Hevea latex alternatives' above.)
● Additional management measures – Additional measures advised for patients with
latex allergy include having autoinjectable epinephrine available, carrying nonlatex
gloves, wearing a medical alert bracelet, and requesting a latex-safe environment for
procedures or employment. Although allergy to latex has decreased in prevalence,
clinicians should not discount the risk of anaphylaxis in a patient with a "latex allergy"
label that is reported in their medical record. (See 'Individuals' above.)

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