Latex Allergies

by Food and Drug Administration (FDA)

Every Thursday, Sue Lockwood's eyes would start to swell. Fridays were always the worst. Sometimes her eyes were so swollen she could hardly see. But, without fail, by the time Monday rolled around, the swelling was gone and her eyes were fine.

"I thought that I was allergic to the sand that I was playing volleyball in every Thursday," says Lockwood, who lives in Grafton, Wis. "The sand would get in my eyes and I thought I was breaking out from the sand."

But, although Lockwood quit playing volleyball in August 1991, the problem with her eyes persisted into the fall.

Two ophthalmologists told her that her symptoms didn't indicate an eye infection. Finally, in October she went to see an allergist.

"After interviewing me and getting a medical history he told me he was sure I was latex sensitive. Sure enough, he drew blood and I tested positive."

What were the clues that led to the allergist's conclusion? First, Lockwood is a surgical technician. Like most health-care workers today, Lockwood practically lived in latex gloves at work.

Second, her work schedule was Tuesdays, Wednesdays, and every other Thursday. That explained the miserable Fridays and recovery by Monday.

And then there was the volleyball. "It turns out she didn't use a standard volleyball," says her allergist, B. Lauren Charous, M.D. "Her team used a red rubber volleyball."

Latex is the milky sap from the rubber tree Hevea brasiliensis. It doesn't cause problems for most people. But, like other things in nature — bee sting venom, poison ivy, peanuts — latex can cause problems for some people. Those problems can range from minor skin irritation to reactions so severe that emergency medical treatment is necessary to prevent death.

For those allergic to the rubber tree's sap the only sure solution is to stay away from it. But latex products are everywhere, especially in health-care settings. It is found in all kinds of medical devices, most notably the ubiquitous surgical and examination gloves that health-care workers wear. Most condoms and diaphragms are made of latex. And latex is found in many everyday items, including balloons, household gloves, underwear, and rubber bands.

Few know better than Lockwood the surprising places latex can show up. "I don't know what I'm going to run into next," she says. She's reacted to the new carpet in her mother's house (the carpet backing contained latex) and to her nieces' and nephews' rubber toys.

New Problem or Old?

The British first discovered latex in the mid-18th century, but it didn't come into wide use until about 50 years ago. It took several more decades before allergic reactions started to appear.

In 1979, a woman in Great Britain who reacted to her household rubber gloves was the subject of the first report of latex allergy in the medical literature. Between 1979 and 1988, about 50 cases were recorded in European medical journals. Then, things began to change.

In the fall of 1989, the Food and Drug Administration started receiving reports of patients going into anaphylactic shock during radiologic examinations for lower gastrointestinal tract disorders. The patients had all received barium enemas, so at first the barium was suspected. But in some cases, the patients went into shock after the device, a latex-cuffed enema tip, was inserted but before the barium was administered. In all, 16 people died. The manufacturer of the barium enema tips voluntarily recalled all those on the market and started using tips with silicone cuffs instead. Because that manufacturer dominated the market, at that time FDA felt any further regulatory action was unnecessary.

Then, between March 1990 and January 1991, nine children at a children's hospital in Milwaukee had anaphylactic reactions within 30 minutes after general anesthesia was started but before any surgical incisions had been made. The latex connection was the anesthesia equipment and intravenous catheters. Fortunately, emergency procedures prevented any deaths. Eight of the children, however, required intensive care.

According to Michele Pearson, M.D., an epidemiologist with the national Centers for Disease Control, preliminary results of a nationwide survey of children's hospitals have identified at least 25 other institutions that have reported similar reactions since January 1990. All 75 children who had anaphylactic reactions had either spina bifida or other conditions involving the genitourinary tract. (See accompanying article, "Who's at Risk?")

What was happening? Were the allergic reactions a new phenomenon or just being recognized for the first time?

"I think it is something new," says Jay Slater, M.D., an attending physician in allergy and immunology at Children's National Medical Center in Washington, D.C. He explains that the symptoms and the connection to latex use are fairly easy for an allergist to identify, so it would have been noticed earlier if it had been occurring.

"I can't say that it never occurred before 1979, but I certainly don't think it was that much of a problem before '79."

Slater won't speculate about why allergy to latex has increased so dramatically in the last 13 years, but many others consider "universal precautions" — the use of latex gloves to protect against the AIDS virus — the culprit.

"There's lots of health-care technicians using gloves now who didn't use them before," says Jean Reeder, an Army nurse and immediate past president of the Association of Operating Room Nurses.

"Emergency workers are wearing gloves more often and for longer periods of time," says Jim Paturas, past president of the National Association of Emergency Medical Technicians.

Another possibility is that manufacturers aren't allotting enough time on the production line for washing the latex.

"We assume that more washing will make the latex safer," says Orhan H. Suleiman, Ph.D., chairman of FDA's latex sensitivity task group. Although FDA has no evidence that insufficient washing is an industry-wide problem, in May 1991, the agency outlined in a letter to all manufacturers of latex medical devices a two-step washing procedure — first during a step in the production process called leaching and again after the product is completed — that removes many of latex's allergenic proteins.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.