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FDA approves allergy drug to lessen severity of reactions to peanuts, dairy, other foods

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FDA approves allergy drug to lessen severity of reactions to peanuts, dairy, other foods

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Food allergy sufferers have a new weapon in their fight against severe symptoms.

The U.S. Food and Drug Administration (FDA) has given the injectable Xolair (omalizumab) the green light for use in decreasing the risk of life-threatening reactions to certain foods.

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Xolair was approved for “immunoglobulin E-mediated food allergy in certain adults and children 1 year or older,” the FDA announced on Feb. 16.

This is the first medication the FDA has approved to reduce allergic reactions after accidental exposure to several types of food, the agency stated. 

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Robert A. Wood, M.D., was the principal investigator of the multicenter study that led to the FDA approval.

“Treatment options, aside from strict avoidance, have been very limited for the millions of Americans with severe food allergies,” Wood, director of the Division of Pediatric Allergy, Immunology and Rheumatology at Johns Hopkins University School of Medicine in Baltimore, Maryland, told Fox News Digital.

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The FDA has given the injectable Xolair (omalizumab) the green light for use in decreasing the risk of life-threatening reactions to certain foods. (iStock)

“The lives of these patients and their families are often consumed by fear of accidental exposure to food allergens — and even with strict avoidance, accidental exposures are common.”

“The approval of Xolair for the treatment of food allergy will be very meaningful, and potentially even life-changing, for people with food allergies,” Wood added.

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Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America (AAFA), a nonprofit headquartered in Maryland, was not involved in the medication research but spoke with Fox News Digital about the recent approval.

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“The stress of living with food allergies can weigh heavily on people and their families, particularly when navigating events like children’s birthday parties, school lunches and holiday dinners with friends and family,” Mendez said.

“Given the growing prevalence of food allergies, this news offers hope to the many children and adults who may benefit from a new way to help manage their food allergies.”

Boy peanuts

Milk, eggs, fish, crustacean shellfish, wheat, soy, peanuts, and tree nuts account for the most serious allergic reactions in the U.S. (iStock)

Individuals must still avoid foods they’re allergic to, even if they take Xolair, the FDA noted in the announcement.

“This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies,” Kelly Stone, M.D., PhD, associate director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.

“While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs.”

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Risk reducer, not cure

Xolair, made by Genentech in California, is not approved for the immediate emergency treatment of allergic reactions. It is also not a substitute for current emergency treatments, the federal agency stated.

Such emergency treatments include doses of epinephrine and EpiPens to prevent anaphylaxis, which is a severe allergic reaction that can potentially be fatal, health experts told Fox News Digital.

Food allergen test

Individuals must still avoid foods they are allergic to, even if they take Xolair, the FDA noted in the announcement. (iStock)

Nearly 6% of U.S. adults and children suffer from food allergies, according to the Centers for Disease Control and Prevention (CDC) — and more than 40% of children with food allergies in the U.S. have been treated in the emergency department.

Dr. Fred Davis, associate chair of emergency medicine at Northwell Health in New Hyde Park, New York, said he sees a number of allergic reactions from exposure to food.

“This drug may be able to lower that risk,” he told Fox News Digital.

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“Remember that this is a preventative drug, not a medication to be used after exposure when one is having an acute allergic reaction,” Davis cautioned.

“This news offers hope to the many children and adults who may benefit from a new way to help manage their food allergies.”

“The recent FDA approval of Xolair for food allergies marks another important step forward for the 33 million Americans living with this condition,” Dr. Susan Schuval, chief of the Division of Pediatric Allergy/Immunology at Stony Brook Children’s Hospital on Long Island, New York, told Fox News Digital.

“Although Xolair is not a cure for food allergies, its use may lessen the risk of severe reactions from accidental food exposures. Patients will still need to practice food avoidance and carry epinephrine injectors,” Schuval said. 

EpiPen

Emergency treatments include doses of epinephrine and EpiPens to prevent anaphylaxis, which is a severe allergic reaction that can potentially be fatal. (iStock)

As there is currently no cure for food allergies, the CDC recommends strict avoidance of any foods that cause them.  

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Milk, eggs, fish, crustacean shellfish, wheat, soy, peanuts, and tree nuts account for the most serious allergic reactions in the U.S., per the agency.

IgE-mediated food allergies — the most severe — occur when the body’s immune system mistakenly perceives a food particle as a harmful invader.

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A type of antibody called immunoglobulin E (IgE) contributes to the immune response, which can include stomach issues, itching, hives or anaphylaxis, according to several health experts. 

Xolair helps dampen this immune response by targeting certain receptors in the body. 

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“It is an injection that works on blocking IgE, reducing the risk of an allergic reaction, but needs to be taken regularly to work,” Davis told Fox News Digital. 

Research behind the approval

The FDA’s approval decision was based on a study that explored the effectiveness and safety of Xolair in 168 participants ranging from babies to adults.

All participants were allergic to peanuts and at least two other foods, which included milk, wheat, egg, walnut, hazelnut or walnut. 

Woman breathing issues

A type of antibody called immunoglobulin E (IgE) contributes to the body’s immune response, which can include stomach issues, itching, hives or anaphylaxis. (iStock)

Participants received either Xolair or a placebo for 16 to 20 weeks. 

Sixty-eight percent of those who received Xolair were able to tolerate the equivalent of 2½ peanuts without a moderate or severe allergic reaction, compared to 6% who took the placebo. 

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Also among the participants who received the Xolair injections, 67% of people with egg allergies, 66% of people with milk allergies and 42% of people with cashew allergies were able to consume a single dose (1,000 milligrams or greater) of cashew, milk or egg protein without moderate to severe allergic symptoms. 

The agency recommended that an individual should only start the medication in a health care setting equipped to manage anaphylaxis. 

Patients should discuss with their health care provider whether Xolair is the right choice for them, experts said.

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Fox News Digital reached out to the FDA for additional comment.

For more Health articles, visit www.foxnews.com/health.

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Health weekend roundup: A mother's health mission, sleep-blocking foods, heat illnesses and more

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Health weekend roundup: A mother's health mission, sleep-blocking foods, heat illnesses and more

Fox News Digital publishes an array of health pieces all week long to keep you in the know on a range of wellness topics: health care access, innovative surgeries, cancer research, mental health trends and much more — plus, personal stories of people and families overcoming great obstacles.

Check out some top recent stories in Health as your weekend continues — and prep for the week ahead.

CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER

These are just a few of what’s new, of course. 

There are many more to see at http://www.foxnews/health

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Americans need more sleep and less stress

Many U.S. adults are getting too little sleep and have too much stress, according to a new Gallup poll. 

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The poll showed that 63% of Americans who reported wanting more sleep also “frequently experience stress.” (iStock)

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Americans need more sleep, less stress, experts say, as Gallup poll reveals troubling findings

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Americans need more sleep, less stress, experts say, as Gallup poll reveals troubling findings

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Many Americans are getting too little sleep and have too much stress.

A new Gallup poll revealed 57% of adults would “feel better if they got more sleep,” while 42% said they get “as much sleep as they need.”

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These findings have nearly reversed in the last decade, Gallup noted in a press release. The last measurement in 2013 found that 56% of Americans got the sleep they needed while 43% did not.

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Overall, however, Americans are getting fewer hours of sleep than they did in past decades.

In 1942, 59% of Americans were getting eight hours or more of sleep per night, while only 3% were getting five hours or less.

Fifty-seven percent of adults said they would “feel better if they got more sleep,” a new Gallup poll revealed. (iStock)

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In 2024, only 25% of Americans get an average of eight hours of sleep, and 20% reported sleeping for five or less.

Young women are the least likely to get enough sleep, according to the study — with 36% of females versus 48% of males reporting getting enough shuteye.

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Sleep amounts for both men and women showed “significant declines from previous readings in 2013 and 2004,” according to Gallup — and are the lowest measured for each group to date.

The decline was found across all age groups, although young adults between ages 18 and 29 saw the smallest difference.

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Stress-sleep connection

Gallup suggested that an uptick in stress could be driving this downward trend in sleep, as the American Psychological Association reports a “strong connection between stress and sleep quality.”

The poll showed that 63% of Americans who reported wanting more sleep also “frequently experience stress.”

Tired woman at computer

Women are most likely to frequently experience stress, the Gallup poll found. (iStock)

“Over the past 30 years, the number of Americans who are stressed has been on a steady incline after a sharp drop in 2003,” Gallup reported.

“The most recent data show that nearly half of all Americans, 49%, report frequently experiencing stress — up 16 points over the past two decades and the highest in Gallup’s trend to date.”

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Young women are also most likely to frequently experience stress, “exceeding men their age by 14 points,” according to Gallup.

Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, confirmed this relationship between sleep and stress, calling it the “cycle of worry” during a Thursday appearance on “America’s Newsroom.”

dr. marc siegel on america's newsroom

Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, discussed the relationship between sleep and stress during a Thursday appearance on “America’s Newsroom.” He noted that exposure to the blue light of smartphone screens can keep people awake, among other issues. (Fox News)

“They’re connected,” he said. 

“If you get more stressed, you don’t sleep; if you don’t sleep, you get more stressed.”

Siegel explained that “all of this spirals out of control,” since sleeplessness is often remedied with caffeine — yet caffeine “interferes with your sleep cycle.”

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“If you get more stressed, you don’t sleep; if you don’t sleep, you get more stressed.”

The same goes for drinking alcohol before bed to induce sleep, which “wears off and you wake up in the middle of the night,” the doctor warned. 

Exposure to the blue light of smartphone screens can keep people awake, Siegel said.

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“All of this is very bad for health,” he said. “It leads to heart disease, it increases your risk of stroke, it causes you to gain weight.”

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For young women in particular, several factors could be causing them to lose sleep, including the use of social media, which can “feed anxiety,” Siegel said.

Man on phone

A potential fix to ending the sleep-stress cycle is practicing “sleep hygiene,” said one doctor, which includes sleeping in a dark room away from your cellphone. (iStock)

A potential fix for the sleep-stress cycle is practicing “sleep hygiene,” Siegel suggested, which includes sleeping in a dark room away from your cell phone.

“I treat stress and sleeplessness as the same thing,” he said. “That’s why I don’t believe in sleeping pills … You’re just covering up the problem.”

He added, “I want to get at why you’re worried and what I can do about the worry.”

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Dr. Wendy Troxel, a Utah-based sleep expert and senior behavioral scientist at the RAND Corporation, told Fox News Digital in an interview that stress levels have remained “very high” since the COVID pandemic.

“[For] populations navigating multiple demands, including young people who are going to school or starting new jobs in this topsy-turvy world, it’s understandable that they are experiencing increases in stress, and that’s manifesting increases in sleep disturbances,” she said.

dr. wendy troxel headshot

Dr. Wendy Troxel, senior behavioral scientist at RAND Corporation, is also the author of “Sharing the Covers: Every Couple’s Guide to Better Sleep” and scientific advisor for sleepfoundation.org. “As a culture,” she said, “we’ve become more aware of the importance of sleep over the past 10 years, which is a great thing.” (Diane Baldwin)

In some instances, Troxel pointed out, lack of sleep has been worn as a “badge of honor” to prove that people are busy or productive.

“But I think that that cultural misconception is starting to wane,” she said.

“The reality is, as a culture, we’ve just become more aware of the importance of sleep over the past 10 years, which is a great thing.”

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To break the “vicious cycle” of stress impacting sleep and vice versa, Troxel offered several tips, including maintaining a consistent sleep and wake schedule to ensure that stress doesn’t “invade your life.”

Incorporating a wind-down routine prior to bed can also bring down stress levels, the sleep expert noted.

These routines can involve relaxing activities such as deep breathing exercises, cuddling with a partner, journaling, doing gentle yoga or listening to music.

man meditates at night on his bed

Wind-down activities before bed can include deep breathing exercises, cuddling with a partner, journaling, doing gentle yoga or listening to music. (iStock)

“It’s just about finding something that you can ritualize and do on a nightly basis to set the stage … to put aside all the demands and stress of the day and prepare for winding down and [going] to sleep,” Troxel said.

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For people who wake up in the middle of the night due to stress, she advised getting out of bed, performing a wind-down activity and then returning to bed.

This technique, called stimulus control, prevents the brain from forming the habit of waking up at a certain time to ruminate on stressful thoughts.

“We all have occasional stress-related sleep disturbances, but if that starts happening night after night, it becomes habit-forming,” she said. 

“And that’s where we see more chronic problems like insomnia. So, if you see that happening, treat it as a habit that your brain is learning — and break it.”

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