« June 2016 »
1 2 3 4
5 6 7 8 9 10 11
12 13 14 15 16 17 18
19 20 21 22 23 24 25
26 27 28 29 30
You are not logged in. Log in
Entries by Topic
All topics  «
DUFFY Media Publications
Welcome to the Blog
Blog Tools
Edit your Blog
Build a Blog
RSS Feed
View Profile

Sunday, 12 June 2016
CORPORATE GREED: EPIPEN Goes From $60 To Over $613




EPIPEN Goes From $60 To Over $613



Former hedge fund manager Martin Shkreli had the Internet ablaze after hiking the price of the drug that's been on the market for decades.  An HIV/AIDS patient advocacy group began raising questions about why Turing Pharmaceuticals jacked up the price for a medication from $13.50 per pill to $750 overnight, anger against the company has been boiling over.


The medicine, Daraprim, which has been on the market for 62 years, is the standard of care for a food-borne illness called toxoplasmosis caused by a parasite that can severely affect those with compromised immune systems. Turing purchased the rights to the drug and almost immediately raised prices.


Alarmed consumers took to Reddit to call for a boycott of the company's products (with some pointing out that it's hard to boycott a drug if you'll die without it) and calling for new laws to prevent this kind of thing from happening in the future.


Judith Aberg, a spokeswoman for the HIV Medicine Association, has calculated that even patients with insurance could wind up paying $150 per pill out of pocket. The enormous, overnight price increase for Daraprim is just the latest in a long list of skyrocketing price increases for certain critical medications.  Americans should not have to live in fear that they will die or go bankrupt because they cannot afford to take the life-saving medication they need.


In 2016, Mylan Pharmaceuticals took the same approach as Martin Shkreli and raised what was once an affordable life saving drug to one that is not affordable.  Yet, there was no public outcry like that heard when Shkreli did the same thing.


Heather Bresch, is the CEO of Mylan Pharmaceuticals makes a lot of money.  Her total compensation is $9.96 million. Her compensation is broken down as follows: At $998,077, Bresch's base salary is the only one on our list to dip below $1 million. But her stock and options helped make up for that, at $2.84 million and $1.38 million, respectively. Plus, her incentive pay amounted to $2.375 million. She received $1.96 million in pension benefits and deferred compensation, plus $405,683 in other compensation, including $133,346 in personal use of the company aircraft.


Bresch grew up in Fairmont and Farmington, West Virginia. Her father, Joe Manchin is current a United States Senator in West Virginia.   Bresch attended high school in West Virginia. She also graduated from (WVU) in 1991 with a bachelor's degree in political science and international relations.


Bresch was an MBA student at WVU until 1998. In 2007, the Pitsburgh Post-Gazette reported that Bresch had claimed to have an MBA degree from West Virginia University, but the university disputed that. The university subsequently awarded her an MBA despite her not having attained sufficient credits (22 out of the required 48). In the ensuing controversy, the university announced in April 2008 that it would rescind Bresch's degree. Michael Garrison, WVU President at the time, was reported to be "a family friend and former business associate of Bresch" and a former consultant and lobbyist for Mylan. After a faculty vote of no confidence, Garrison and several university officials subsequently resigned.


From 2002 to 2005, Bresch served as Mylan's director of government relations. She contributed to the development of the 2003 Medicare Prescription Drug, Improvement, and Modernization Act (MMA, also known as "Medicare Part D).


When Mylan expanded internationally, Bresch noticed that Mylan's US-based pharmaceutical manufacturing plant had full-time staff from the  FDA devoted to it, whereas facilities abroad had not been inspected by the FDA for more than a decade.


Bresch persuaded several of Mylan's competitors to support what became the Generic Drug User Fee Act, which she proposed to lawmakers in 2010. Under the law the pharmaceutical industry would pay fees of $300 million in order to fund FDA inspections of foreign drug manufacturing facilities at the same rate as US-based facilities.


To advocate for the new law, she made regular visits to Washington, D.C., and sponsored a whitepaper.  The Generic Drug User Fee Act of 2012 was passed on July 9, 2012 and required FDA inspections of pharmaceutical manufacturing locations abroad if they are importing into the US.


Bresch has also advocated for broader availability of Epipens in public places to treat anaphylaxis (severe allergic reactions), and has been active in raising awareness of HIV/AIDS treatment in developing nations.  She helped facilitate the School Access to Emergency Epinephrine Act, which made epinephrine more accessible in schools.


In a 2007 purchase of medicines from Merck KGaA, drugmaker Mylan picked up a decades-old product, the EpiPen auto injector for food allergy and bee-sting emergencies. Management first thought to divest the aging device, which logged only $200 million in revenue. Then Heather Bresch, now Mylan’s chief executive officer, hit on the idea of using old-fashioned marketing in part to boost sales among concerned parents of children with allergies. That started EpiPen, which delivers about $1 worth of the hormone epinephrine, on a run that’s resulted in its becoming a $1 billion-a-year product that clobbers its rivals and provides about 40 percent of Mylan’s operating profits, says researcher. EpiPen margins were 55 percent in 2014, up from 9 percent in 2008.


How Mylan pulled that off is a textbook case in savvy branding combined with a massive public awareness campaign on the dangers of child allergies. Along the way, EpiPen’s wholesale price rose roughly 400 percent from about $57 each when Mylan acquired the product. “They have done a tremendous job of taking an asset that nobody thought you could do much with and making it a blockbuster product,” says Jason Gerberry, a Leerink Partners analyst.


But while EpiPen has given countless parents a sense of security that their children can go out in the world safely, the device’s soaring price—up 32 percent in the past year alone—has forced some families to make difficult choices in order to afford the life-saving medicine. The price increases are among the biggest of any top-selling brand drug, according to DRX, a unit of Connecture that tracks drug pricing. After insurance company discounts, a package of two EpiPens costs about $415, DRX says. By comparison, in France, where Meda sells the drug, two EpiPens cost about $85. “There is a danger with that,” says George Sillup, chairman of the pharmaceutical and health-care marketing department at Saint Joseph’s University. If the company raises the price too much, “that could create some backlash.” People will die because they will use expired epipens or worse, not purchase one and they need it.


The company sees it differently. “Mylan has worked tirelessly over the past years advocating for increased anaphylaxis awareness, preparedness, and access to treatment,” Mylan spokeswoman said in a statement.  They also said the company doesn’t control final retail prices for EpiPen and offers coupons that eliminate co-pays for most patients. Bresch declined to comment for this story. These coupons that they make reference to range from $5 to $25 off the price of the epipen.


The CEO has made no secret of her strategy to increase demand for EpiPens by getting them stocked for emergency use in more schools and other public places. (So-called entity prescriptions allow for this.) “We are continuing to open up new markets, new access with public entity legislation that would allow restaurants and hotels and really anywhere you are congregating, there should be access to an EpiPen,” Bresch  has said.  So, then why the massive price increase patients are asking. As the demand has increased the costs to manufacture the drug have gone down, significantly. The more you make the less it costs to make it.


Over the past seven years, Mylan has hired consultants who had worked with Medtronic to get defibrillators stocked in public places. Bresch, the daughter of Senator Joe Manchin (D-W.Va.), turned to Washington for help. Along with patient groups, Mylan pushed for federal legislation encouraging states to stock epinephrine devices in schools.


In 2010, new federal guidelines said patients who had severe allergic reactions should be prescribed two epinephrine doses, and soon after Mylan stopped selling single pens in favor of twin-packs. At the time, 35 percent of prescriptions were for single EpiPens. The U.S. Food and Drug Administration had changed label rules to allow the devices to be marketed to anyone at risk, rather than only those who’d already had an anaphylaxis reaction. These are both big events that Bresch has capitalized on, at the risk of patient safety.


In 2013, the year following the widely publicized death of a 7-year-old girl at a school in Virginia after an allergic reaction to peanuts, Congress passed legislation encouraging states to have epinephrine devices on hand in schools. Now 47 states require or encourage schools to stock the devices.


Since 2012, Mylan has helped popularize its brand by handing out free EpiPens to more than 59,000 schools. Last year it signed a deal with Walt Disney to stock EpiPens in Disney’s theme parks and on cruise ships. We will guess that this was not done for free. Is Disney paying $600 a pop for the epipens?

Mylan also spent $35.2 million on EpiPen TV ads in 2014, up from $4.8 million in 2011, according to researcher Nielsen. Mylan disputes the ad spending figures but declines to offer alternatives. Is Bresch really concerned about people having reactions or just concerned about her own golden parachute?


In part because of Mylan’s efforts, the number of patients using EpiPen has grown 67 percent over the past seven years. Many kids with allergies own multiple sets, for school and home. And for doctors, who write prescriptions for the name they know best, the EpiPen brand “is like Kleenex,” says Robert Wood, a pediatric allergist at Johns Hopkins University School of Medicine. However, Bresch has made the Epipen cost a lot more than Kleenex.


So far rivals haven’t been able to break Mylan’s market grip. Sanofi’s Auvi-Q, introduced in 2013, is in the shape of a credit card and—unlike EpiPen—gives step-by step audio instructions. But Sanofi priced Auvi-Q about the same as EpiPen, and the product struggled initially to gain insurance coverage. Sanofi says 9 out of 10 patients with commercial insurance can now receive coverage for Auvi-Q prescriptions. Yet in the first half of 2015, EpiPen had about an 85 percent share of epinephrine prescriptions vs. only 10 percent for Auvi-Q, according to Symphony Health Solutions data compiled by Bloomberg.


Still, allergy sufferers without generous health benefits feel the pain. Denise Ure, a social worker in Seattle, has a peanut allergy so severe that the last time she ingested a nut crumb in 2011, she needed three EpiPens and was hospitalized. Ure says she cried last year when she found out a prescription for two EpiPens would cost her about $350. “I was terrified because there’s this life-saving medicine that I needed, and I couldn’t afford it,” she says. Ure now carries two EpiPens she got in Canada, where they cost about half as much.


The biggest threat to EpiPen could come from Teva Pharmaceutical Industries. It settled a patent lawsuit in 2012 allowing it to market a generic version of EpiPen as early as this year, if it wins FDA approval. Mylan isn’t too worried. Predicted Bresch in August: “You would not see the traditional market loss because of just the brand equity with EpiPen.


The bottom line: When Mylan bought EpiPen in 2007, the devices had $200 million in annual sales. Today revenue exceeds $1 billion.


The author of this article is no stranger to anaphylactic events. In her lifetime she has had over 10 significant events. All related to unknown cross contamination, hidden peanut oil used to cook their food, or an establishment who served food with nuts, it was returned and all they did was remove the hunk of nuts.


One such event came from eating dehydrated vegetable soup by Alessi.  All the author did was add boiling water to the soup. Within minutes of eating the soup she had head to toe hives that were multiplying by the minute. Her throat began to close off and she could not breath. By the time she got to the ER, she was in bad shape. The emergency room team was able to bring her back to normal but it took 4 days for the swelling to dissipate.

She had saved the pouch from the soup, for she could not understand what happened. She contacted Alessi and they investigated it. It turned out that the vegetable soup was packaged in the same plant where they packaged their biscotti cookies (that are loaded with nuts). They sent her 3 packages of olive oil for her troubles. She did not use the olive oil, although appreciated the gesture.


This is just one example. She is currently planning a trip to Africa and part of the planning process for trips is to ensure the chefs have the ability to handle her nut allergy. There were many hotels that said, No, tell her to bring her epipen." Imagine her dismay when she went to get a new one for the trip and find it cost $614 at CVS with insurance. A call to the company only told her to go to the epipen.com cost to get a coupon. A coupon that ranged from $5 to $25. YIPEE!!


An epinephrine autoinjector or epipen is a medical device for injecting a measured dose or doses of adrenaline by means of autoinjector technology. It is most often used for the treatment of anaphylaxis. The EpiPen is derived from the MARK I NAAK ComboPen, which was developed for the U.S. military for treating exposure to nerve agents in the course of chemical warfare.


After activation, the patient holds the device in place for between 5 and 10 seconds as the epinephrine is delivered. This gives the drug enough time to be absorbed by the body's muscles and diffused into the bloodstream.

Auto-injectors are sometimes used unnecessarily. Injection into a vein (intravenous injection) can be fatal. It can cause ventricular tachycardia, in which the heart beats uncontrollably and is not able to pump blood adequately. It can also restrict blood flow to the area of the injection site, and damage the extremities.[2] After administering the device, patients are advised to seek immediate medical attention.

An emergency technique (not manufacturer-approved) to obtain additional epinephrine from a used autoinjector has been published in the medical literature.[3]

Units that have exceeded their expiration date can still be used in an emergency if an unexpired unit is unavailable and the solution is neither discoloured nor contains precipitates.[4]


Anaphylaxis is a life-threatening allergic reaction that has many possible triggers, occurs quickly, without warning, and must be treated immediately with epinephrine. Symptoms may include hives, itching, swelling or redness of the skin, tightness in the throat, nausea, dizziness, breathing problems, a decrease in blood pressure and/or fainting. Anaphylaxis can be caused by triggers, such as food, stinging and biting insects, medicines, latex or even exercise. While symptoms of an allergic reaction vary from person to person, reactions can quickly progress to become life-threatening.


Food allergies are a growing public health concern.  As many as 15 million people have food allergies. An estimated 9 million, or 4%, of adults have food allergies.  Nearly 6 million or 8% of children have food allergies with young children affected. 


Food allergies may be a trigger for or associated with other allergic conditions, such as atopic dermatitis and eosinophilic gastrointestinal diseases.


Although childhood allergies to milk, egg, wheat and soy generally resolve in childhood, they appear to be resolving more slowly than in previous decades, with many children still allergic beyond age 5 years. Allergies to peanuts, tree nuts, fish, or shellfish are generally lifelong allergies and even progress in severity as we age in some cases.


The prevalence of food allergies and associated anaphylaxis appears to be on the rise. In 2008, the CDC reported an 18 percent increase in food allergy among children between 1997 and 2007.  According to a study released in 2013 by the Centers for Disease Control and Prevention, food allergies among children increased approximately 50% between 1997 and 2011. The economic cost of children’s food allergies is nearly $25 billion per year.


There are eight foods that account for 90% of all food-allergic reactions: milk, eggs, peanuts, tree nuts (e.g., walnuts, almonds, cashews, pistachios, pecans), wheat, soy, fish, and shellfish.  An estimated prevalence, some based on self-report, among the U.S. population:

o Peanut: 0.6-1.3%

o Tree nuts: 0.4-0.6%

o Fish: 0.4%

o Crustacean shellfish (crab, crayfish, lobster, shrimp): 1.2%

o All seafood: 0.6% in children and 2.8% in adults


 A study has shown that peanut can be cleaned from the hands of adults by using running water and soap or commercial wipes, but not antibacterial gels alone. In addition, peanut was cleaned easily from surfaces by using common household spray cleaners and sanitizing wipes but not dishwashing liquid alone.  Some studies have also shown that most individuals with peanut and soy allergies can safely eat highly refined oils made from these ingredients. However, cold-pressed, expeller-pressed, or extruded oils should be avoided.


Casual exposure, such as skin contact and inhalation, to peanut butter is unlikely to elicit significant allergic reactions. However, those with significant reactions to nuts can demonstrate hives and GI disturbances just from sitting near people eating a food containing nuts.


According to the Food Allergen Labeling and Consumer Protect Act (FALCPA) the major eight allergens must be declared in simple terms, either in the ingredient list or via a separate allergen statement. However, FALCPA does not regulate the use of advisory/precautionary labeling.


Eating away from home can pose a significant risk to people affected by food allergy. Research suggests that close to half of fatal food allergy reactions are triggered by food consumed outside the home.  One study looking at peanut and tree nut allergy reactions in restaurants and other food establishments found that reactions were frequently attributed to desserts, that Asian restaurants and take-out dessert stores (bakeries, ice cream shops) were common sources of foods that triggered reactions, and that the food establishment was often not properly notified of a food allergy by the customer with the allergy.


Research on self reported reactions occurring on commercial airlines show that reactions to peanuts and tree nuts do occur on airlines via ingestion, contact, and inhalation. Ingestion of an allergen remains the main concern for severe reactions.


The CDC reported that food allergies result in more than 300,000 ambulatory-care visits a year among children under the age of 18. From 2004 to 2006, there were approximately 9,500 hospital discharges per year with a diagnosis related to food allergy among children under age 18 years.  Even a small amounts of a food allergen can cause a reaction.  Most allergic reactions to foods occurred to foods that were thought to be safe. Allergic reactions can be attributed to a form of mislabeling or cross-contact during food preparation.


 Food allergies are the leading cause of anaphylaxis outside the hospital setting.  Every 3 minutes a food allergy reaction sends someone to the emergency department– that is about 200,000 emergency department visits per year, and every 6 minutes the reaction is one of anaphylaxis.  A failure to promptly (i.e., within minutes) treat food anaphylaxis with epinephrine is a risk factor for fatalities.


Unfortunately, there is no cure for food allergies. Strict avoidance of food allergens and early recognition and management of allergic reactions to food are important measures to prevent serious health consequences.


We can only hope that the CEO of Mylan does some deep soul searching and decreases the cost of this life saving drug. Or maybe, TEVA pharmaceuticals will get their generic approved and sweep Mylan under the carpet as it pertains to their financial position on this drug.






What are the common signs and symptoms of anaphylaxis?

A: According to a 2010 article published in The Journal of Allergy and Clinical Immunology, during anaphylaxis symptoms can  range from mild to severe and may affect:

• Skin (up to 90% of episodes): hives (urticaria), itching (pruritus), flushing, itching and swelling of lips, tongue, uvula/palate2,3,4,5,6

• Airway (up to 70% of episodes): shortness of breath, chest tightness, wheezing, itchy throat, hoarseness (dysphonia)2,4,5,6

• Gastrointestinal system (up to 45% of episodes): nausea, cramping, abdominal pain, vomiting, diarrhea2,4,5,6

• Cardiovascular system (up to 45% of episodes): hypotension, chest pain, fast heart rate (tachycardia), weak pulse,

dizziness, fainting2,4,5,6

• Central nervous system (up to 15% of episodes): feelings of uneasiness, throbbing headache, dizziness, confusion,

tunnel vision2,5

Q: How quickly do symptoms appear?

A: Symptoms typically appear within minutes to a few hours following contact with an allergen.1,7

Q: How many Americans are at risk for anaphylaxis?

A: Though data on anaphylaxis incidence and prevalence are sparse and often imprecise, estimates indicate that anaphylaxis is a growing health problem that may affect 3 to 43 million Americans. There has been an increase in life-threatening allergic reactions in recent years, but as evidence by the range provided, more research needs to be conducted


How are people treated for anaphylaxis?

A: According to food allergy guidelines released in December 2010 by the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), epinephrine is the only first-line treatment in all cases of anaphylaxis (including from food allergies) and should be available at all times to people at risk for anaphylaxis.3 Avoidance of allergic triggers is the critical first step to prevent a serious health emergency; however, accidental exposure may still happen.6,13

According to NIAID, if experiencing anaphylaxis, use an epinephrine auto-injector and seek immediate emergency medical attention.Carrying an epinephrine auto-injector does not prevent patients from having an anaphylactic reaction; hence, patients must avoid

their allergen at all times.3,6,14


Q: When should epinephrine be administered?

A: Epinephrine is the only first-line treatment in all cases of anaphylaxis (including from food allergies).3 If experiencing anaphylaxis, use an epinephrine auto-injector and seek immediate emergency medical attention.3

Anaphylaxis occurs when an allergic reaction involves one body system, either respiratory or cardiovascular alone; it may also occur in multiple body systems, such as the skin, gastrointestinal, and/or central nervous system.1 It is important to carry an epinephrine autoinjector if you have been diagnosed with life-threatening allergies. Carrying an epinephrine auto-injector does not prevent patients from having an anaphylactic reaction; hence, patients must avoid their allergen at all times.3,6,14

It is important to remember that the benefits of epinephrine treatment outweigh the risks of delayed or no administration. Delays in epinephrine administration have been associated with negative health consequences, even possibly death.15,16,17 Since

there are no absolute contraindications to epinephrine administration for an anaphylactic reaction, it is important to administer epinephrine immediately even if all criteria for anaphylaxis diagnosis have not yet been met.5


Q: How many doses of epinephrine are recommended for an individual to have on hand?

A: Epinephrine takes effect within minutes, but it is rapidly metabolized. As a result, its effect can be short-lived and repeated dosing may be necessary. In fact, according to a 2005 literature review published in the Annals of Allergy, Asthma & Immunology, up to 20% of individuals who receive epinephrine will require more than one dose before symptoms are alleviated.18 The NIAID food allergy guidelines recommend that all patients at risk for or who have experienced anaphylaxis have access to two doses of epinephrine at all times.3 Seek immediate medical attention after use.


Q: Are antihistamines a viable treatment option for anaphylaxis?

A: Antihistamines are not indicated to treat the life-threatening symptoms of anaphylaxis. Antihistamines are useful for relieving itching and hives. They do not relieve shortness of breath, wheezing, gastrointestinal symptoms or shock. Therefore, antihistamines should be considered adjunctive therapy and should not be substituted for epinephrine.3

Despite these facts, the use of antihistamines is the most common reason reported for not using epinephrine and may place a patient at significantly increased risk for progression toward a life-threatening allergic reaction.


What happens when a person has a life-threatening allergic reaction to food?

A: Food allergy-induced anaphylaxis occurs when the immune system is exposed to a specific food that triggers the release of chemicals, including histamine, resulting in symptoms of a life-threatening allergic reaction.3 Symptoms may include low blood

pressure, difficulty in breathing, nausea and/or vomiting.2


Q: How many Americans have food allergies?

A: While the exact prevalence of food allergies is uncertain, a 2010 study in The Journal of Allergy and Clinical Immunology estimated 2.5% of Americans have a clinical food allergy.20 A study in the July 2011 issue of Pediatrics found that 8% of children suffer from a food allergy — a considerable increase from previously reported figures.21

Q: Is there a cure for food allergies?

A: There is no cure for food allergies. Avoidance of allergic triggers is the critical first step to prevent a serious health emergency; however, accidental exposure may still happen.6,13 In fact, cross-contamination of otherwise safe foods at the time of packaging or food preparation (especially in restaurants) remains a potential hazard for individuals with food allergies.22 This is why it is important to be prepared with an anaphylaxis action plan, which includes avoiding known allergens, recognizing symptoms and having access to two epinephrine auto-injectors.1,12,23

Q: Are food allergies on the rise?

A: The Centers for Disease Control and Prevention reported in 2008 that an 18% increase in food allergy was seen between 1997 and 2007.24 A study published in the July 2011 issue of Pediatrics found a considerable increase in food allergy from previously reported figures — it found that 8% of children in the U.S., or approximately one out of 13, suffer from a food allergy. Of those children affected, 38% had a history of a severe reaction, and 30% had allergies to multiple foods.21 The prevalence of peanut allergies among children under 18 significantly increased from 0.4% in 1997 to 1.4% in 2008 (p <


Q: How many children are at risk for anaphylaxis from food allergies?

A: A study published in the July 2011 issue of Pediatrics found that an estimated one out of 13 children in the U.S. suffer from a food allergy, a considerable increase from previously reported figures.21 A survey conducted in 109 Massachusetts school districts

from 2001 to 2003 evaluating the use of epinephrine for anaphylaxis management in schools found that up to 24% of anaphylactic reactions occurred in individuals who were not known by school personnel to have a prior history of life-threatening allergies.


What is causing the increase in food allergies?

A: There is no definitive answer as to why food allergies are increasing. One theory, called the hygiene hypothesis, suggests that modern hygienic processes and a generally more sterile environment have reduced exposure to certain bacteria. To compensate, the immune system is conditioned toward an allergic state.13

Q: Can the severity of food allergy-induced anaphylaxis be predicted based on a person’s prior reactions?

A: The severity of food allergy-induced anaphylaxis cannot be predicted based on a person’s prior reactions. An estimated 22% of people who experience fatal food-induced anaphylaxis have had a previous severe reaction.27 The severity of a food-triggered life-threatening allergic reaction depends on a number of factors, including the amount eaten,

the food form (cooked, raw or processed) and the co-ingestion of other foods. Other considerations include the person’s age, the body’s sensitivity at time of ingestion, the speed at which food is absorbed by the body, and whether the person has another life-threatening condition, such as severe or uncontrolled asthma.22

Q: What are the most common food allergens associated with anaphylaxis?

A: The most common food allergens that can cause anaphylaxis are cow’s milk, eggs, wheat, soybeans, peanuts, tree nuts (walnuts, cashews, pistachios, pecans, etc.), fish and shellfish.13

Q: Why is food intolerance often confused with food allergies?

A: According to the NIAID food allergy guidelines, food allergies and food intolerance share some of the same symptoms; however, food intolerance does not involve the immune system. It can cause great discomfort but is not life-threatening. Some

people with food intolerances are not able to digest certain foods because their bodies lack the specific enzyme needed to break down that food.


What should people at risk for anaphylaxis look for in food labels?

A: By law, the eight major allergens (cow’s milk, eggs, wheat, soybeans, peanuts, tree nuts including walnuts, cashews, pistachios and pecans, fish and shellfish) must be noted on all packaged food labels in the U.S., either in the ingredient list or

on a separate allergen statement.29 However, individuals with food allergies should be aware that advisory or precautionary labeling (i.e., “may contain,” “in a facility that also processes”) is not regulated and is solely voluntary.29

Q: Other than food, what are the most common triggers that lead to anaphylaxis?

A: Other common triggers of anaphylaxis are insect venom, latex, medications or exercise-induced. In about 20% of cases, no trigger is identified, known as idiopathic anaphylaxis.







1Branum A, Lukacs S. Food allergy among U.S. children: Trends in prevalence and hospitalizations. National

Center for Health Statistics Data Brief. 2008. Retrieved from http://www.cdc.gov/nchs/data/databriefs/db10.htm

2National Institute of Allergy and Infectious Diseases, National Institutes of Health. Report of the NIH Expert Panel on Food Allergy Research. 2006. Retrieved from www3.niaid.nih.gov/topics/foodAllergy/research/ReportFoodAllergy.htm

3U.S. Census Bureau.State and County QuickFacts. 2010. Retrieved from quickfacts.census.gov/qfd/states/00000.html

4Gupta RS, Springston, MR, Warrier BS, Rajesh K, Pongracic J, Holl JL. The prevalence, severity, and distribution of childhood food allergy in the United States. J Pediatr.2011; 128.doi: 10.1542/peds.2011-0204

5Liu AH, Jaramillo R, Sicherer SH, Wood RA, Bock AB, Burks AW, Massing M, Cohn RD, Zeldin DC. National

prevalence and risk factors for food allergy and relationships to asthma: Results from the National Health and

Nutrition Examination Survey 2005-2006. J Allergy ClinImmunol.2010; 126: 798-806.

6Centers for Disease Control and Prevention. QuickStats: Percentage of children aged <18 years with food, skin, or hay fever/respiratory allergies --- National health interview survey, United States, 1998—2009. 2011. Retrieved

from www.cdc.gov/mmwr/preview/mmwrhtml/mm6011a7.htm?s_cid+mm6011a7_w

7U.S. Census Bureau. State and County QuickFacts.2010. Retrieved from quickfacts.census.gov/qfd/states/00000.html

8Sampson HA. Update on food allergy. J Allergy ClinImmunol.2004; 113(5): 805-19.

9NIAID-Sponsored Expert Panel. Guidelines for the diagnosis and management of food allergy in the United

States: Report of the NIAID-sponsored expert panel. J Allergy ClinImmunol.2010; 126(6):S1-S58.

10Liacouras CA, Furtura GT, Hirano I, Atkins D, Attwood SE, Bonis PA, et al. Eosinophilic esophagitis: Updated consensus recommendations for children and adults. J Allergy ClinImmunol.2011.doi: 10.1016/j.jaci.2011.02.040

11 Skripak JM, Matsui EC, Mudd K, Wood RA. The natural history of IgE-mediated cow's milk allergy. J Allergy

Clin Immunol 2007; 120(5):1172-7.

12 Savage JH, Matsui EC, Skripak JM, Wood RA. The natural history of egg allergy. J Allergy Clin Immunol 2007;


13 Keet CA, Matsui EC, Dhillon G, Lenehan P, Paterakis M, Wood RA. The natural history of wheat allergy. Ann

Allergy Asthma Immunol 2009; 102(5):410-5.

14 Savage JH, Kaeding AJ, Matsui EC, Wood RA. The natural history of soy allergy. J Allergy Clin Immunol 2010;


15Sicherer SH, Munoz-Furlong, A, Sampson HA. Prevalence of seafood allergy in the United States determined by a random telephone survey. J Allergy ClinImmunol.2004; 114: 159-165.

16Jackson K et al. Trends in Allergic Conditions among Children: United States, 1997-2011. National Center for Health Statistics Data Brief. 2013. Retrieved from http://www.cdc.gov/nchs/products/databriefs/db121.htm17Gupta R, et al. The high economic burden of childhood food allergy in the United States. Ann Allergy Asthma Immunol, 2012; 109: A1-A162.

18May CD. Objective clinical and laboratory studies of immediate hypersensitivity reactions to food in asthmatic children. J Allergy ClinImmunol.1976; 58: 500-515.

19 Bock SA, Buckley J, Holst A, May CD. Proper use of skin tests with food extracts in diagnosis of hypersensitivity to food in children. J Allergy ClinImmunol.1977; 7: 375.

Food Allergy Research & Education

www.foodallergy.org • (800) 929-4040

20 Bock SA, Lee W-Y, Remigo LK, et al. Appraisal of skin tests with food extracts for diagnosis of food hypersensitivity. J Allergy ClinImmunol.1978; 8: 559.

21Sampson HA, Albergo R. Comparison of results of skin tests, RAST and double-blind, placebo-controlled food challenges in children with atopic dermatitis. J Allergy ClinImmunol.1984; 74: 26-33.

22 Sampson HA, McCaskill CM. Food hypersensitivity and atopic dermatitis: evaluation of 113 patients. J. Pediatr.1985; 107: 669-75.

23Bock SA, Sampson HA, Atkins FM, et al. Double blind placebo controlled food challenge (DBPCFC) as an office procedure: A manual. J Allergy ClinImmunol.1988; 82: 986-997.

24 Bock SA, Atkins FM. Patterns of food hypersensitivity during 16 years of double-blind placebo-controlled food challenges. J Pediatr.1990; 117: 561-567.

25 Perry TT, Conover-Walker MK, Pomes A, Chapman MD, Wood RA. Distribution of peanut allergen in the environment. J Allergy Clin Immunol.2004; 113(5): 973-976.

26Bush RK, Taylor SL, Nordlee JA, Busse WW. Soybean oil is not allergenic to soybean-sensitive individuals. J Allergy Clin Immunol.1985; 76: 242–245.

27Taylor SL, Busse WW, Sachs M1, Parker JL, Yunginger JW. Peanut oil is not allergenic to peanut-sensitive individuals. J Allergy Clin Immunol.1981; 68: 372-5.

28 Hoffman DR, Collins-Williams C. Cold-pressed peanut oils may contain peanut allergen. J Allergy

ClinImmunol.1994; 93: 801-2.

29Keating MU, Jones RT, Worley NJ, Shively A,Yunginger JW. Immunoassay of peanut allergens in food- processing materials and finished foods. J Allergy Clin Immunol.1990; 86: 41-4.

30Crevel RW, Kerkhoff MA, Koning MG. Allergenicity of refined vegetable oils. Food and Chemical

Toxicology.2000; 38(4): 385-393.

31Hefle SL, Taylor SL. Allergenicity of edible oils. Food Technol. 1999; 53: 62–70

32Simonte SJ, Sonhui M, Shideh M, Sicherer S. Relevance of casual contact with peanut butter in children with peanut allergy. J Allergy Clin Immunol, 2003(112):180-182.

33Wainstein BK, Kashef S, Ziegler M, Jelley D, Ziegler JB. Frequency and significance of immediate contact reactions to peanut inpeanut-sensitive children. Clin Exp Allergy. 2007; 37(6): 839–845.

34Crespo JF, Pascual C, Dominguez C, Ojeda I, Munoz FM, Estaban MM. Allergic reactions associated with airborne fish particles in IgE-mediated fish hypersensitive patients. Allergy.1995; 50: 257-61.

35Roberts G, Golder N, Lack G. Bronchial challenges with aerosolized food in asthmatic, food-allergic children.Allergy.2002; 57: 713-7.

36U.S. Food and Drug Administration. Food allergen labeling and consumer protection act of 2004 (public law

108-282, title II). Retrieved from http://www.fda.gov/food/labelingnutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm


37 Ford LS, Taylor SL, Pacenza R, Niemann LM, Lambrecht DM, Sicherer SH. Food allergen advisory labeling and product contamination with egg, milk, and peanut. J Allergy Clin Immunol.2010; 126(2): 384-5.

38 Bock SA, Muñoz-Furlong A., Sampson H. Further fatalities caused by anaphylactic reactions to food, 2001-

2006. J Allergy Clin Immunol. 2007; 119(4): 1016-8.

39Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy

ClinImmunol.2001; 107(1): 191-3.

40 Sampson HA, Mendelson L, Rosen J. Fatal and near-fatal anaphylactic reactions to food in children and adolescents. N Engl J Med.1992; 327(6): 380-4.

41Furlong TJ, DeSimone J, Sicherer SH. Peanut and tree nut allergic reactions in restaurants and other food establishments. J Allergy ClinImmunol.2001; 108: 867-70

42Sicherer SH, Furlong TJ, DeSimone J, Sampson HA. Self-reported allergic reactions to peanut on commercial airliners. J Allergy ClinImmunol.1999; 103(103):186-189.

43 Comstock SS, DeMera R, Vega L, Boren EJ, Deanne S, Haapanen LA, Teuber SS. Allergic reactions to peanuts, tree nuts, and seeds aboard commercial airliners. Ann Allergy Asthma Immunol, 2008; 101: 51-56.

44Greenhawt MJ, McMorris MS, Furlong TJ. Self-reported allergic reactions to peanut and tree nuts on commercial airlines. J Allergy Clin Immunol, 2009;124(3): 598-599. doi: 10.1016.jaci.2009.06.039

45Laoprasert N, Wallen N, Joes R, et al. Anaphylaxis in a milk-allergic child following ingestion of lemon sorbet containing trace quantities of milk. Journal of Food Protection.1998; 61: 1522-4.

46Gern, J, Yang E, Evrard H, Sampson HA. Allergic reactions to milk-contaminated ‘non-dairy’ products. N Engl J Med. 1991; 324: 976-9.

47Yunginger J, Gauerke, M, Joes R, et al. Use of radioimmunoassay to determine the nature, quantity and source of allergenic contamination of sunflower butter. Journal of Food Protection.1983; 46: 625-8.

Food Allergy Research & Education

www.foodallergy.org • (800) 929-4040

48Jones R., Squillace, D., Yunginger, J. Anaphylaxis in a milk-allergic child after ingestion of milk contaminated kosher-pareve-labeled ‘dairy-free’ dessert. Annals of Allergy.1992; 68: 223-7.

49Hourihane J, Kilbrun S, Nordlee J, et al. An evaluation of the sensitivity of subjects with peanut allergy to very low doses of peanut: a randomized, double-blind, placebo-controlled food challenge study. J Allergy

ClinImmunol.1997; 100: 596-600.

50U.S. Food and Drug Administration.Approaches to establish thresholds for major food allergens and for gluten in food. 2006.

51Sampson HA. Anaphylaxis and emergency treatment. J Pediatr.2004; 111: 1601–1608.

52Clark S, Espinola J, Rudders SA, Banerji, A, Camargo CA. Frequency of US emergency department visits for food-related acute allergic reactions. J Allergy ClinImmunol. 2011; 127(3): 682-683.

53 Ellis AK, Day JH. Incidence and characteristics of biphasic anaphylaxis: a prospective evaluation of 102 patients. Annals of Allergy, Asthma & Immunology.2007: 64-69.

54Korenblat P, Lundie MJ, Danker RE, Day JH. A retrospective study of epinephrine administration for anaphylaxis: how many doses are needed? Allergy Asthma Proc. 1999; 20: 383-386.

55 U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition. Food allergies: What you need to know. 2008. Retrieved fromhttp://www.cfsan.fda.gov/~dms/ffalrgn.html

56American Academy of Allergy, Asthma and Immunology, and American College of Allergy, Asthma and

Immunology.Joint Task Force on Practice Parameters; Joint Council of Allergy, Asthma and Immunology. J

Allergy Clin Immunol. 2005; 115: S483-523.

57McIntre CL, Sheetz AH, Carroll CR, Young MC. Administration of epinephrine for life-threatening allergic reactions in school settings. J Pediatr. 2005; 116(5): 1134-1140.

58 Nowak-Wegrzyn A, Conover-Walker MK, Wood RA. Food-allergic reactions in schools and preschools. Arch

Pediatr Adolesc Med. 2001; 155(7): 790-795.

59Sicherer SH, Furlong TJ, DeSimone J, Sampson HA. The US peanut and tree nut allergy registry:

characteristics of reactions in schools and day care. J Pediatr. 2011: 128(4): 560-565.

60McIntre CL, Sheetz AH, Carroll CR, Young MC. Administration of epinephrine for life-threatening allergic reactions in school settings. J Pediatr.2005; 116(5): 1134-1140.

61Gold MS, Sainsbury R.First aid anaphylaxis management in children who were prescribed an epinephrine autoinjector device (EpiPen). J Allergy Clin Immunol. 2000; 106(1 pt 1): 171-176.

62 Sicherer, SH. Epidemiology of food allergy. J Allergy Clin Immunol. 2011; 127: 594-602.


Posted by tammyduffy at 7:43 PM EDT

View Latest Entries