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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.”

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.

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“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.

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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.

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“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.

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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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Goodbye, Late-Night Cravings! How To Curb Hunger and Make Weight Loss Easier

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Goodbye, Late-Night Cravings! How To Curb Hunger and Make Weight Loss Easier


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Lurking dementia risk exposed by breakthrough test 25 years before symptoms

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Lurking dementia risk exposed by breakthrough test 25 years before symptoms

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A new blood test could determine a woman’s dementia risk as early as 25 years before symptoms emerge.

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That’s according to new research from the University of California San Diego, which found that a specific biomarker protein associated with early pathological processes of Alzheimer’s disease was “strongly linked” to future dementia risk.

The researchers analyzed blood samples from 2,766 participants in the Women’s Health Initiative Memory Study in the late 1990s, according to the study’s press release. 

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The women ranged from 65 to 79 years of age and showed no signs of cognitive decline at the start of the study.

After tracking the participants for up to 25 years, the researchers concluded that the biomarker phosphorylated tau 217 (p-tau217) was “strongly associated” with future mild cognitive impairment and dementia. 

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A new blood test could determine a woman’s dementia risk as early as 25 years before symptoms emerge. (iStock)

Women who had higher levels of p-tau217 at the beginning of the study were “much more likely” to develop the disease. The findings were published today in JAMA Network Open.

“The key takeaway is that our study suggests it may be possible to detect risk of dementia two decades in advance using a simple blood test in older women,” first author Aladdin H. Shadyab, a UC San Diego associate professor of public health and medicine, told Fox News Digital. 

“These biomarkers may help us identify who is at greatest risk and develop strategies to delay or prevent dementia.”

“Our findings show that the blood biomarker p-tau217 could help identify individuals at higher risk for dementia long before symptoms begin,” he added.

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This long lead time could open the door to earlier prevention strategies and more targeted monitoring, rather than waiting until memory problems are already affecting daily life, according to Shadyab.

A specific biomarker protein associated with early pathological processes of Alzheimer’s disease was “strongly linked” to future dementia risk. (iStock)

“As the research advances, these biomarkers may help us identify who is at greatest risk and develop strategies to delay or prevent dementia,” he said.

This risk relationship wasn’t the same across the board, however. Women over 70 with higher p-tau217 levels had “poorer cognitive outcomes” compared to those under 70, as did those with the APOE ε4 gene, which is a known risk factor for Alzheimer’s disease.

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The study also found that p-tau217 was a stronger predictor of dementia in women who were randomly assigned to receive estrogen and progestin hormone therapy compared to those who received a placebo.

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“Blood-based biomarkers like p-tau217 are especially promising because they are far less invasive and potentially more accessible than brain imaging or spinal fluid tests,” said senior author Linda K. McEvoy, senior investigator at Kaiser Permanente Washington Health Research Institute and professor emeritus at the Herbert Wertheim School of Public Health, in the release. 

“Blood-based biomarkers like p-tau217 are especially promising because they are far less invasive and potentially more accessible than brain imaging or spinal fluid tests,” a researcher said. (iStock)

“This is important for accelerating research into the factors that affect the risk of dementia and for evaluating strategies that may reduce risk.”

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Blood tests for Alzheimer’s disease are still being studied and are not recommended for routine screening in people without symptoms, Shadyab noted. 

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More research is needed before this approach can be considered for clinical use prior to cognitive symptoms. 

Future studies should investigate how other factors — like genetics, hormone therapy and age-related medical conditions — might interact with plasma p-tau217, the researchers added.

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“The study examined only older women, so the findings may not necessarily apply to men or younger populations,” Shadyab noted. “We also examined overall dementia outcomes rather than specific subtypes such as Alzheimer’s disease.”

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Key fitness measure is strong predictor of longevity after certain age, study finds

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Key fitness measure is strong predictor of longevity after certain age, study finds

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For women over 60, muscle strength plays a critical role in longevity, a new study confirms.

Researchers at the University at Buffalo, New York, followed more than 5,000 women between the ages of 63 and 99, finding that those with greater muscle strength had a significantly lower risk of death over an eight-year period.

The findings were published in JAMA Network Open.

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Muscle function was measured using grip strength and how quickly participants could complete five unassisted sit-to-stand chair raises. 

These are two tests commonly used in clinical settings to evaluate muscle function in older adults, the researchers noted.

A recent study shows that stronger muscle strength in women over 60 is linked to a lower risk of death over eight years. (iStock)

“In a community cohort of ambulatory older women, muscular strength was associated with significantly lower mortality rates, even when we accounted for usual physical activity and sedentary time measured using a wearable monitor, gait speed and blood C-reactive protein levels,” study lead author Michael LaMonte, research professor of epidemiology and environmental health at the University at Buffalo, told Fox News Digital.

“Movement is the key — just move more and sit less.”

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Many earlier studies did not include those objective measurements, making it difficult to determine whether muscle strength itself was linked to longevity, according to LaMonte. “Our study was able to better isolate the association between strength and death in later life,” he added.

Even for women who don’t get the recommended amount of aerobic physical activity, which is at least 150 minutes per week, muscle strength remained important for longevity, the researchers found.

Women with greater muscle strength were more likely to live longer, even if they did not meet the recommended amount of aerobic exercise. (iStock)

“The findings of lower mortality in those who had higher strength but were not meeting current national guidelines on aerobic activity were somewhat intriguing,” LaMonte said.

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Federal guidelines recommend strengthening activities one to two days per week, targeting major muscle groups.

Resistance training does not have to require a gym membership, LaMonte noted. These exercises can be performed using free weights, resistance bands, bodyweight movements or even household items, such as soup cans.

Experts recommend working major muscle groups one or two days a week using weights, bands or bodyweight exercises. (iStock)

“Movement is the key — just move more and sit less,” he said. “When we can no longer get out of the chair and move around, we are in trouble.”

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LaMonte acknowledged several limitations of the study. The researchers assessed muscle strength in older age but did not explore how earlier levels in adulthood might influence long-term health outcomes.

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“We were not able to understand how strength and mortality relate in younger ages,” he said, noting that future research should explore whether building strength earlier could have an even greater impact on longevity.

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