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Latex Free Claims: a White Paper on the Risks Associated with Latex Allergies and Latex in Healthcare

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Latex Free Claims: a White Paper on the Risks Associated with Latex Allergies and Latex in Healthcare Latex Free Claims: A White Paper on the Risks Associated with Latex Allergies and Latex in Healthcare Brought to you by: Allergy and Asthma Network: Sue Lockwood and Robert Hamilton, M.S., Ph.D. Avella Specialty Pharmacy: Eric Sredzinski, Pharm.D., AAHIVP and Jenna Vaughn, Pharm.D., PGY1 Executive Summary There is significant confusion as to the meaning of “latex free” in healthcare. The FDA has urged manufacturers to drop the term “latex free” or a ”does not contain latex” claim from labels because of the challenge to ensure a product is completely devoid of natural rubber latex proteins which cause the allergic reactions. While there are no regulations requiring the On December 2, labeling of a medical product to state natural rubber latex was not used as a material in the manufacturing process, the terms “latex free” or 2014, the FDA “does not contain latex” are used too broadly. According to the FDA, these labeling techniques are not sufficiently specific, not necessarily scientifically released the accurate, and may be misunderstood and applied too widely. final latex guidance On December 2, 2014, the FDA released the final latex guidance document document advising [https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/UCM342872.pdf] advising firms to use “not made with firms to use natural rubber latex” if no natural (Hevea brasiliensis) rubber latex was used in the "not made manufacturing process. Not all types of latex are from natural rubber latex; for example, products that contain nitrile and polyvinyl chloride, will not cause a with natural natural rubber latex allergy because these are synthetic formulations. rubber latex" In 2012, The Journal of Investigational Allergology and Clinical Immunology if no natural published a position paper on latex allergy that provides a comprehensive review on latex allergy and reviews processes to identify and manage (Hevea brasiliensis) patients with latex allergies. To best protect patients with a suspected but rubber latex unverified latex allergy, a detailed patient history on past exposures and reactions must be obtained and documented. For patients with a known was used in the latex allergy, any products containing natural rubber latex must be avoided. However, it may be impossible to be 100% confident that a complete manufacturing natural rubber latex environment can be achieved. Label confusion process continues and understanding the labeling techniques as well as the FDA guidance document is key to be informed. If there is a question on the potential natural latex content of a product, the primary vendor or supplier should be contacted for additional information. 2 Purpose The purpose of this white paper is to educate those involved in healthcare The risk of developing about important issues relating to the use of Hevea brasiliensis latex, latex allergies, and available alternatives. a latex allergy Introduction increases with repeat Latex as raw, natural rubber is harvested from the milky sap of the rubber exposure and tree, Hevea brasilienesis, which is principally grown throughout Indonesia, Thailand and Vietnam (2). Latex in its raw form contains 60 polypeptides proteins that have been identified as potentially allergenic, 15 of which are 8–12% principal allergens (7, Table 1). Hevea latex has become prevalent in modern society because of its resistance to chemicals, elasticity, comfort, ease of of healthcare manufacturing, and low cost. Due to these benefits, thousands of products workers reportedly contain natural rubber latex and most have the potential to trigger an allergic reaction (Table 2). Latex-caused allergic reactions, seen both in the have developed general population and healthcare workers, are a serious medical concern. The risk of developing a latex allergy increases with repeat exposure and a sensitivity to 8–12% of healthcare workers reportedly have developed a sensitivity to natural rubber natural rubber latex compared to 1–6% of the general population (7). Steps must be taken to ensure that the risk of an allergic reaction is kept latex compared to at a minimum, and the use of synthetic latex and other alternatives should be considered when feasible. 1–6% Table 1 — Latex Allergens of the general Allergen Properties population Hev b 1 and 3 Main allergen in spina bifida patients Hev b 5 and 6 Main allergen in healthcare workers Hev b 2, 4, 7, and 13 Secondary allergen in healthcare workers Hev b 6.02 and 7 Seen in allergen cross-reactivity with fruits Hev b 8, 11, and 12 Panallergens with unknown cross-reactivity with fruits Table 2 — Latex: Common and Medical Common Items Healthcare Items Containing Hevea Latex Containing Hevea Latex Balloons Catheters Compression Stockings Condoms Syringes Stethoscopes Toys Vial Stoppers Masks Erasers Bandages Tape Rubber Bands Gloves Adhesives Sports Balls (Tennis, Basketball) Blood Pressure Cuffs Injection Ports Therapy Bands Rubber Accelerators Electrode Pads Elastic 3 Latex Allergies In the late 1980s, universal precautions in healthcare were introduced to prevent the spread of HIV. The use of latex gloves and other protective devices also increased, leading to an explosion of allergies of epidemic proportions. Healthcare workers are naturally at a greater risk for developing latex allergies due to repeat exposure to latex-containing gloves and medical equipment. However, after peaking in the mid-1990s, latex allergies have been on the decline with the increased use of synthetic substitutes and increased awareness of the risks associated with latex. The allergenic proteins found within the latex of natural rubber and the chemicals added in the manufacturing process can lead to three types of adverse effects: irritant contact dermatitis, allergic contact dermatitis, and immediate-type allergic reactions (4, Table 3). Irritant contact dermatitis is a non-allergic, localized inflammation of the skin caused by chemical irritation and not by latex allergens. Allergic contact dermatitis, known as type IV hypersensitivity, is limited to the skin and is a T-cell mediated reaction to chemicals added during production. Irritant contact dermatitis and type IV reactions are both marked by redness, lesions, or itching, which weakens the skin barrier and allows allergens easy access into the body. Immediate-type allergic reactions, known as type I hypersensitivities, are mediated by the Hevea latex-specific IgE antibodies in response to exposure to latex proteins. These can be deadly, with a 1% lethality rate. Type I reactions are caused by the release of histamine and leukotrienes from mast cells. Symptoms include: itching, papules, angioedema, asthma, and anaphylaxis (5). Table 3 — Reactions to Latex Reaction Type Symptoms Cause Time of Onset Urticaria (hives), nausea, vomiting, rhinitis, Immediate hypersensitivity Latex allergens Immediate and within conjunctivitis, bronchospasms, and (Type I) -15 known types minutes anaphylactic shock Allergic contact dermatitis Chemicals/rubber Delayed, takes up to 48 Rash, itching, vesicles, redness, and blisters (Type IV) accelerators in latex hours after contact Chemicals/rubber Gradual and over Irritant contact dermatitis Dry, cracked, red, and irritated skin accelerators in latex several days Routine testing of all patients and healthcare workers who are at risk or suspected of having a latex allergy is essential to preventing a reaction. Latex allergy testing includes the patch test, skin prick, intradermal test, IgE antibody immunoassays, and a use (glove application challenge) test (1). The patch test is used to detect irritant contact dermatitis in patients and involves placing a patch with latex chemicals on a patient’s skin for 2-3 days. The puncture/prick skin test looks for type I reactions; to perform it, a drop of latex extract is scratched into a patient’s skin. An intradermal test is similar to a prick test as a latex solution is inserted into the skin and the patient is observed for a type I reaction. Intradermal tests must be performed cautiously as they generate higher levels of allergic reactions and have the potential to trigger anaphylaxis. Importantly, neither a puncture nor 4 intradermal skin test can be performed in the United States due to an absence of an FDA-cleared Hevea latex skin testing reagent. Thus, IgE immunoassays that are used to detect the presence of Hevea latex specific-IgE antibodies in a patient’s serum are the only confirmatory test available at present in the USA. However, latex skin test reagents are available elsewhere in the world. If a serological assay for IgE antibody is negative but the patient has reported symptoms of a latex allergy, then a simple use test may be cautiously performed. With a use test, the fingertip of a latex glove is dampened and then placed upon a patient’s hand for 15 minutes. If the patient does not react to the fingertip, then the entire dampened latex glove is placed on the patient for another 15 minutes and they are observed for a reaction. The efficacy of this use test is highly dependent on the Hevea latex content in the glove used for the evaluation. Latex skin prick testing through a glove is NOT recommended in the United States, due to many reported adverse reactions. So, physicians must rely on clinical judgement and by obtaining an individual’s history, including association between latex exposure and the development of symptoms. If a patient begins to show signs or symptoms of a natural rubber latex allergy, Importantly, neither a then swift action is important to preventing further injury (1). For an irritant or allergic contact dermatitis reaction, washing the area with soap and water will puncture nor quickly remove the allergen. If the rash is significant, the next step is to apply topical corticosteroids or hydrating creams to ease pain, inflammation, and intradermal itching. Dangerous type I reactions require immediate attention by removing skin test can be the individual from the offending substance, washing the area of contact, monitoring vital signs, and administering emergency treatment if needed.
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