Natural Rubber Latex Allergy (NRL) Fact Sheet

What Is Latex Allergy?

It is an allergic reaction to products made from natural rubber latex (NRL). It should not be confused with the more common irritant type reactions that are caused by direct injury to the skin, as from frequent hand-washing with detergents. Latex products contain native or endogenous substances such as proteins as well as added processing chemicals. A person can be allergic to the proteins, the focus of this fact sheet, or to the chemicals.

Who Is At Risk?

People who are genetically susceptible to latex allergy, just as some people are genetically susceptible to developing hay fever, and bee sting and peanut allergies, can become allergic after exposure to latex-containing products. People with atopy (a history of multiple allergies, e.g., hay fever, food allergy, asthma, eczema) also can develop latex allergy. According to scientific literature, the major risk groups are:

• Children with spina bifida and other congenital (at-birth) abnormalities. It is thought that since they undergo many medical procedures to correct their medical problems, they are exposed more frequently to products containing NRL. It is not yet known if other genetic factors related to their conditions predispose them to latex allergy.

• Health care workers who are genetically predisposed to latex allergy. To protect themselves from exposure to life-threatening blood-borne diseases like hepatitis and HIV, this group frequently uses and continuously changes NRL gloves throughout the workday as required by the Occupational Safety and Health Administration.

What Kind of Reaction Can I Get From NRL Products?

There are three types of reactions associated with the use of NRL products.

1. Skin irritation is the most common reaction. Symptoms are: dry, cracking skin, skin sores or bumps, and/or itching or rash under the glove area.

2. Allergic contact dermatitis is sensitivity to chemicals used in latex. Symptoms are: dry, cracking skin, skin sores or bumps, and/or itching or rash under the glove and up the arm.

3. Natural rubber latex allergy is caused by proteins in the latex. This serious allergy can cause severe reactions. Symptoms are: hives, skin rash, itching, swelling, sneezing, and/or difficulty breathing.

Is There a Test for Latex Allergy?

Yes. There are skin tests that can identify people who are sensitive to both latex proteins and the processing chemicals. FDA also approved a latex allergy blood test in 1995. However, due to cross reactivity with other allergies, such as ragweed, avocado and banana, the results must be evaluated by a physician in context with other medical and physical information.

How Has Industry Responded to Latex Allergy?

In 1991, manufacturers first learned of severe reactions that were attributed to latex allergy from the Food and Drug Administration (FDA). Early on, they urged FDA to require latex content labeling as a safety measure. They pioneered the research that identified the causes of occupational allergy to NRL, and conducted research on alternative materials, bringing these products to market as quickly as possible so those who are sensitive to NRL have safe and effective alternatives available to them. In fact, some non-latex medical gloves have been available to health care workers since the early 1970's.

Manufacturers have collaborated with the Centers for Disease Control and Prevention (CDC) to examine the prevalence of latex allergy (which isn't known yet) and with FDA to develop educational materials on the proper use of medical gloves. Scientific experts from industry, government and academia have worked hard to develop standard test methods that can be used to assess latex products for levels of allergenic substances. Some of these tests are already being used by manufacturers to better inform users and purchasers of the levels of allergenic substances in NRL products. Additional tests are still in development.

Why Is Latex Important In The Health Care Setting?

• Latex is an effective barrier against HIV, hepatitis B and C, and other blood-borne or sexually transmitted diseases.

• Latex has excellent stretching and conforming properties that don't interfere with the fine manual dexterity needed to perform many medical procedures.

A Latex History

• NRL has been around since 50 A.D., and came into wide commercial use about 50 years ago.

• It comes from the Hevea brasiliensis tree found in tropical forests. As a naturally-derived material, it is an environmentally-friendly product throughout its entire life-cycle.

• NRL usage dramatically increased after 1987, when the CDC recommended that health care workers practice universal precautions to protect them from HIV infection.

• In 1991, FDA reported 16 deaths in patients who went into anaphylactic shock after exposure to NRL-collared barium enema tips. This product has since been voluntarily taken off the market.

• In 1991, the Occupational Safety and Health Administration published its Occupational Exposure to Bloodborne Pathogens Standard, which mandated universal precautions.

• In 1992, manufacturers of medical devices began to voluntarily label their products as to NRL content. In 1996, FDA published a proposed regulation to require such labeling.