Latex Allergies: When Rubber Rubs the Wrong Way
by Dori Stehlin

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.

Testing for Latex Allergy

There are two ways to test for latex allergies. With one--the skin-prick      
test--tiny diluted amounts of latex or one of its proteins are injected       
under the skin or applied to a small scratch or puncture on the patient's     
arm or back. If the patient is allergic, a small, raised area surrounded by   
redness appears at the test site within about 15 minutes.

Laboratory analysis of a blood sample to detect antibodies is the other       
testing option. (The first time an allergic person is exposed to an           
allergen, the immune system produces a kind of antibody called                
immunoglobulin E--IgE for short.)

Slater says testing is both very important, and, unfortunately, imperfect.    
"It is clear that history alone is inadequate to screen some patients," he    
explains. (Some of the people who died from reactions to the latex barium     
enema tips had no history of latex allergy.) But, currently there is no       
FDA-approved extract for the skin-prick test or the blood test. Without an    
approved standard extract, the accuracy of the test results is not reliable.

The lack of an approved material that will identify latex-sensitive patients  
stems in part from latex's complexity. "We're comfortable that at least one   
of the proteins in latex is the problem," says FDA's Suleiman. But he adds    
that more than a dozen proteins have been identified in latex. "Which one of  
these actually initiates the [allergic] reaction? At this time, your guess    
is as good as mine."

He adds, however, that a tremendous amount of research has been stimulated    
by questions about latex's proteins.

In addition, latex from some sources, such as different brands of gloves,     
may cause more severe reactions than that from other sources, according to    
Harvard dermatology professor Ernesto Gonzalez in the February 1992 issue of  
the journal Hospital Practice.

Still, Slater says people in high-risk groups should be tested if they are    
concerned, as long as the tests are part of a through examination by an       
allergist who has the background to recognize possible allergens and exclude  
others based on an individual's history of allergic reactions. "It requires   
a fair amount of detective work," he says.

In addition, the allergist should be prepared with emergency equipment in     
case the skin-prick test itself causes a severe allergic reaction.

Slater warns that people shouldn't try to test themselves, by, for example,   
blowing up a latex balloon.

"That's a lousy idea," he says. "In fact, it's potentially very dangerous."   
He explains that a truly allergic person could go into shock from such a      
"test."

Finally, Slater says people who are not in a high-risk group and who haven't  
had any history of reactions "need to sit tight."

Suleiman agrees. "Right now, unless someone is already sensitive [to latex]   
there's no reason to discontinue use. We especially don't want to scare       
people away from latex condoms."

While approximately 1 billion to 2 billion condoms are used per year in the   
United States, FDA has received only 44 reports of allergic reactions         
associated with condom use between October 1988 and the end of 1991.

Latex Free

Surgery is nothing new for 7-year-old Paul Reynolds, of Herndon, Va. He was   
born with spina bifida, and last September's hip operation was his eighth.    
But, unlike the previous seven, this was his first surgery since he had       
developed an allergy to latex.

Paul's mother, Adriana Reynolds, says the doctors assured her the surgery     
would be latex free "as much as possible. I used to worry about the risks of  
anesthesia, but now I think this rubber allergy is my greatest concern."

Latex-containing devices fill the average surgical suite, and sometimes even  
medical professionals aren't aware that a device has a latex component.

"What is needed in the anesthesia world is a list of devices that don't have  
latex," says Jane McCarthy, a nurse-anesthetist and member of FDA's latex     
task group. "The clinicians can only attempt at best to provide an            
environment that's latex free. There's been difficulty in doing that because  
the devices aren't labeled with or without latex."

In response to that need, several hospitals have developed their own lists    
of latex-free devices. In addition, two nurse-anesthetists, Charles R.        
Barton and Cynthia A. Roy, have developed a list of commonly used medical     
devices that contain latex. (See accompanying chart).

To make sure a patient's latex allergy isn't overlooked, FDA sent a medical   
alert to approximately 1,000 leaders of health professional organizations in  
March 1991. The alert advised health professionals to:
--include questions about latex sensitivity when taking a patient's health    
history. (Asking patients if they've ever experienced itching, rash or        
wheezing after wearing latex gloves or inflating a toy balloon may be         
useful.) 
--flag the charts of patients who report signs of latex allergy
--counsel patients who have a suspected latex-related allergic reaction       
while under the professional's care, and recommend a latex allergy test to    
those individuals.

The agency also recommended that when health professionals are treating a     
latex-sensitive patient, they should wear a non-latex glove over a latex      
glove. If both the health professional and patient are sensitive,             
triple-gloving--wearing a glove liner or vinyl glove under a latex glove as   
well as a vinyl glove over the latex--is recommended. (See accompanying       
article, "Why Stick with Latex?")

To protect themselves, Slater recommends that people allergic to latex:
--carry non-latex gloves (a medium size is their best bet) at all times for   
health professionals to use during both routine examinations and emergency    
procedures
--wear a Medic Alert bracelet
--carry an emergency epinephrine kit in case they are accidently exposed to   
latex and go into anaphylactic shock (epinephrine immediately counteracts     
the shock)
--alert all health professionals they deal with about their latex             
sensitivity. 

For Adriana Reynolds, worry over when and if her son could have another       
reaction is compounded by the lack of knowledge about latex allergies.

"It's all very new," she says. "You tell people that your son has a rubber    
allergy and they say 'rubber?' I've had to meet with the people at Paul's     
school several times to convince them that this is serious. I had to buy      
vinyl gloves for the school nurse [Paul has to be catheterized during the     
day] and remind them about things like rubber balls in physical education."

For Lockwood, the worst part of her allergy is the loss of her career as a    
surgical technician. Since she first started reacting to latex more than a    
year ago, her sensitivity has become so acute that even if she were to wear   
vinyl gloves during surgery, airborne latex from the rest of the surgical     
team's gloves would cause her problems.

"There's no way I can work in surgery anymore," she says. "I can't deal with  
that loss yet.  I want my career back."

Dori Stehlin is a staff writer for FDA Consumer.
Why Stick with Latex?

What is it about latex gloves? Why not just switch everyone to something      
else? 

"We can't switch everybody out of latex," says B. Lauren Charous, M.D.,       
chairman of the American College of Allergy and Immunology's task force on    
latex hypersensitivity. "There's no real reason to. We're still dealing with  
a very small percentage of health-care workers."

There are, however, real reasons to keep donning latex gloves. The main one   
is "latex is the barrier of choice [to protect against HIV]," says Orhan      
Suleiman, Ph.D., chairman of FDA's latex sensitivity task group.

"It's primarily a question of durability," says Thomas Arrowsmith-Lowe,       
D.D.S., deputy director for health affairs in FDA's Center for Devices and    
Radiological Health. "Within 15 minutes after putting on a vinyl glove, it    
starts to lose its barrier effectiveness. Latex maintains the barrier         
longer." 

Of almost equal importance is latex's ability to stretch and conform to the   
shape of the hand. "You can stretch it to four or five times its original     
length and it will not tear," says Barry Page of the Health Industry          
Manufacturers Association. "There aren't many materials that will do that."

In addition, because latex gloves can be stretched so thin, they don't        
interfere with the sensitivity and fine manual dexterity required in many     
medical procedures.

"Latex gloves are better fitting and it's easier to feel veins and start      
IVs," says Vicki Freund, a paramedic/firefighter with the Montgomery County,  
Md., fire department. "So, I end up wearing those."

She also ends up with hives on the backs of her hands. "They itch like        
crazy." Sometimes her eyes swell up and itch and her nose starts running,     
too. 

For now, because her reactions are relatively minor, Freund just lives with   
the problem.

But there are efforts to find an alternative for people like her. Several     
companies have developed latex-free gloves that the companies claim can       
stretch like latex and don't impair the wearer's sense of touch. As with all  
new products that make medical claims, these new gloves have to be reviewed   
by FDA before they can be sold.

Allergist Charous encourages people with mild reactions to try several        
different brands of gloves. He adds that "people who have only a history of   
mild latex glove eczema are not at risk [of a serious reaction] in any        
immediate sense. I want to emphasize that."

--D.S.
Who's at Risk?

Common to all allergic reactions to natural substances is the body's need to  
recognize the substance. The more often the body comes in contact with the    
substance, the greater the opportunity to recognize and react.

For the general public, the risk of an allergic reaction to latex is less     
than 1 percent. But because of constant exposure to latex, two groups are at  
greater risk--health-care workers and children with spina bifida and other    
conditions involving multiple surgical procedures. Because latex-containing   
medical devices abound in surgical suites, dental offices, and other          
health-care settings, contact with latex is an occupational hazard for        
health-care workers. It is also part of daily health maintenance routines     
(for example, catheterization) and the many surgeries high-risk children      
undergo.

According to Jay E. Slater, M.D., attending physician in allergy and          
immunology at Children's National Medical Center in Washington, D.C., the     
risk is so high for children with spina bifida, "we should treat them as      
latex-allergic regardless, whether we know that they are or not."

He cites his own research as the basis for his statement. When he tested the  
blood of 64 spina bifida patients, he found 25 of the children had            
antibodies to latex.

"Among those who had the antibody, approximately half had a history of        
latex-associated reactions," he says. He adds that more and more of these     
kids will have reactions as time goes on.

Allergic reactions to latex can include:
--skin rash
--itching
--hives
--swollen red skin
--tears
--itching or burning eyes
--swollen lips and tongue with difficulty in breathing, wheezing
--shortness of breath
--dizziness
--fainting
--abdominal pain
--nausea
--diarrhea.

In rare cases, an allergic individual goes into shock; blood pressure         
plummets, the throat swells, and airways in the lungs constrict. Without      
immediate treatment, the person will die.

A shot of epinephrine--the same drug used to treat severe allergic reactions  
to bee stings--will counteract the shock if given immediately. n
--D.S.
Commonly Used Latex Medical Products

--rubber gloves
--elastic bandages
--adhesive tape
--urinary catheters
--electrode pads
--wound drains
--stomach and intestinal tubes
--condom urinary collection devices
--protective sheets
--enema tubing tips
--dental cofferdams
--rubber pads
--fluid circulating warming blankets
--hemodialysis equipment
--anesthesia Equipment Containing Latex
--rubber masks
--electrode pads
--head straps
--rubber tourniquets
--rubber nasal-pharyngeal airways
--rubber oral-pharyngeal airways
--teeth protectors
--bite blocks
--blood pressure cuffs
--rubber breathing circuits
--reservoir breathing bags
--rubber ventilator hoses
--rubber ventilator bellows
--rubber endotracheal tubes
--latex cuffs on plastic tracheal tubes
--latex injection ports on intravenous tubing
--certain epidural catheter injection adapters

(Source: Journal of the American Association of Nurse Anesthetists, October   
1991)
Health-Care Workers and Risk of Latex Allergy
operating room doctors 7.5%
operating room nurses 5.6%
dentists 13.7%
other hospital employees 1.3%

(The risk of latex allergy in the general population is 0.8%.)
Latex Conference Planned for November

FDA and the national Centers for Disease Control are sponsoring a conference  
on latex sensitivity Nov. 5 to 7, 1992, which will cover:
--latex chemistry
--prevention of sensitization
--protein quantification and identification
--testing for latex hypersensitivity
--clinical studies
--epidemiology of latex hypersensitivity
--prevention of reactions in sensitized individuals
--manufacturers and producers approaches

To register for the conference or to obtain additional information, write     
Crosspaths Management Systems, Inc., 2 Wisconsin Circle, Suite 660, Chevy     
Chase, MD 20815, or call (1-800) 527-2847.