Health
FDA approves allergy drug to lessen severity of reactions to peanuts, dairy, other foods
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.
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.
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.
“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.”
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.”
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.
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.
“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.
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.
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.
“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.
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.
Fox News Digital reached out to the FDA for additional comment.
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Feeling lonely may take a toll on older adults’ memory — but it may not speed up cognitive decline, according to a new study.
Researchers from Colombia, Spain and Sweden analyzed data from more than 10,000 adults ages 65 to 94 across 12 European countries and found those who reported higher levels of loneliness did worse on memory tests at the start of the study, according to research published this month in the journal Aging & Mental Health.
Over a seven-year period, however, memory decline occurred at a similar rate regardless of how lonely participants felt.
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“The finding that loneliness significantly impacted memory, but not the speed of decline in memory over time was a surprising outcome,” lead author Dr. Luis Carlos Venegas-Sanabria of the School of Medicine and Health Sciences at the Universidad del Rosario said in a statement.
Loneliness may be linked to memory performance in older adults, a new study suggests. (iStock)
“It suggests that loneliness may play a more prominent role in the initial state of memory than in its progressive decline,” Venegas-Sanabria said, adding that the findings highlight the importance of addressing loneliness as a factor in cognitive performance.
The findings add to debate about whether loneliness contributes to dementia risk. While loneliness and social isolation are often considered risk factors for cognitive decline, research results have been mixed.
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The study looked at data from the long-running Survey of Health, Ageing and Retirement in Europe (SHARE), which tracked 10,217 older adults between 2012 and 2019. Participants were asked to recall words immediately and after a delay to measure memory performance.
Social isolation and loneliness could play a surprising role in cognitive health among seniors. (iStock)
Loneliness was assessed using three questions about how often participants felt isolated, left out or lacking companionship.
About 8% of participants reported high levels of loneliness at the outset. That group tended to be older, more likely to be female and more likely to have conditions such as depression.
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Researchers found that those with higher loneliness had lower scores on both immediate and delayed memory tests at baseline. Still, all groups — regardless of loneliness level — experienced similar declines in memory over time.
The results suggest loneliness may not directly accelerate the progression of memory loss, though it remains linked to poorer cognitive performance overall.
Researchers look at a brain scan at the National Institutes of Health in Bethesda, Maryland. (Saul Loeb/AFP/Getty Images)
Experts warn, however, that the findings should not be interpreted to mean loneliness is harmless.
“The finding that lonely older adults start with worse memory but don’t decline faster is actually the most interesting part of the paper, and I think it’s easy to misread,” said Jordan Weiss, Ph.D., a scientific advisor and aging expert at Assisted Living Magazine and a professor at NYU Grossman School of Medicine.
“It likely means loneliness does its damage earlier in life, well before people show up in a study like this at 65-plus,” Weiss told Fox News Digital.
By older age, long-term social patterns may already be established, making it harder to detect when the effects of loneliness first took hold, an aging expert says. (iStock)
He suggested that by older age, long-term social patterns may already be established, making it harder to detect when the effects of loneliness first took hold.
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“By the time you’re measuring someone in their late 60s, decades of social connection patterns are already baked in,” he said.
Weiss, who was not involved in the research, added that loneliness may coincide with other health conditions, and noted that participants who felt more isolated also had higher rates of depression, high-blood pressure and diabetes. The link, he said, may reflect a cluster of health risks rather than a direct cause.
“While they can go hand-in-hand, it’s not clear that loneliness contributes to dementia,” a psychotherapist says. (iStock)
Amy Morin, a Florida-based psychotherapist and author, said the findings reflect a broader pattern in research on loneliness and brain health, and that the relationship may be more complex than it appears.
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“The evidence shows there’s a link between loneliness and cognitive decline but there’s no direct evidence of a cause and effect relationship,” she said. “So while they can go hand-in-hand, it’s not clear that loneliness contributes to dementia.”
Morin added that loneliness, which can fluctuate, may not be the root of the problem, but rather a symptom of other underlying mental or physical health issues.
Researchers suggested screening for loneliness be incorporated into routine cognitive assessments as one way to support healthy aging. (iStock)
She said staying socially and mentally engaged is crucial for overall brain health.
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“It’s important to be proactive about social activities,” Morin said. “Joining a book club, having coffee with a friend, or attending faith-based services can be a powerful way to maintain connections in older age.”
The researchers also suggested screening for loneliness be incorporated into routine cognitive assessments as one way to support healthy aging.
Fox News Digital reached out to the researchers for comment.
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Research continues to uncover new details on how fasting may help extend life.
A new study published in the journal Nature Communications investigated how intermittent fasting can boost longevity in small worms often used in aging research.
Researchers from the University of Texas Southwestern Medical Center in Dallas compared worms that were fed normally to those that underwent a 24-hour fast in early adulthood and were then fed again, according to a press release.
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The scientists measured a variety of factors, including stored fat, gene activity related to fat metabolism and lifespan.
The results showed that the life-boosting benefit did not depend on the fasting itself but on the body’s behavior after eating again.
Experts say sustainability is key when choosing a long-term weight-loss strategy. (iStock)
Study lead Peter Douglas, associate professor of molecular biology and a member of the Hamon Center for Regenerative Science and Medicine at UT Southwestern, suggested that these discoveries “shift the focus toward a neglected side of the metabolic coin – the re-feeding phase.”
“Our data suggest that the health-promoting effects of intermittent fasting are not merely a product of the fast itself, but are dependent on how the metabolic machinery recalibrates during the subsequent transition back to a fed state,” he said.
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“Our findings bridge a gap between lipid metabolism and aging research,” he added. “By targeting aging, the single greatest risk factor for human disease, we move beyond treating isolated conditions toward a preventive model of medicine that enhances quality of life for all individuals.”
Lauri Wright, director of nutrition programs at the University of South Florida’s College of Public Health, called this a “high-quality” study that adds an “important nuance to how we think about fasting and longevity.”
Intermittent fasting typically involves limiting meals to an eight-hour daily window or fasting every other day. (iStock)
The benefits of the refeeding phase after fasting were “especially interesting,” Wright, who was not involved in the study, told Fox News Digital.
“The researchers showed that longevity was linked to the body’s ability to turn off fat breakdown after fasting, allowing cells to restore energy balance,” she reiterated.
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“From a scientific standpoint, that’s a meaningful shift because it suggests fasting is not just about burning fat, but about metabolic flexibility.”
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Fasting may support longevity through triggering metabolic switching, enhancing cellular repair and stress resistance and improving markers like insulin sensitivity, research shows.
Limitations and cautions
Although this study provides “important insight” on the power of refeeding, Wright noted that the findings should be approached with caution, as the study was done on worms and cannot always be translated to humans.
“Additionally, it explains how a process might work in a controlled lab condition rather than real-world eating behaviors,” she added as a limitation. “Finally, the study is short-term and doesn’t give us the long-term translation on lifespan outcomes.”
The review found intermittent fasting was barely more effective than doing nothing, according to the study authors. (iStock)
Wright cautioned that fasting is “not a magic solution for longevity, and how you eat overall matters more than when you eat.”
“I advise, first and foremost, to focus on diet quality, including a variety of fruits and vegetables, healthy fats and minimally processed foods,” she said.
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For those who are considering fasting, it’s better to stick with a moderate plan — like a 12- to 14-hour overnight fast — rather than going to extremes, Wright said. After fasting, she recommends focusing on well-balanced meals.
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Several groups of people should be cautioned against fasting, according to Wright, including those with diabetes who are on insulin or hypoglycemic medications, those who are pregnant or breastfeeding, anyone with a history of eating disorders and older adults at risk of malnutrition.
Anyone considering intermittent fasting should consult with a doctor before starting.
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