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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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'Unsung Hero' Movie Tells the Inspiring True Story of the Smallbone Family — Rebecca St. James and for King + Country’s Joel and Luke

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'Unsung Hero' Movie Tells the Inspiring True Story of the Smallbone Family — Rebecca St. James and for King + Country’s Joel and Luke



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Amid bird flu spread, experts reveal if it's safe to drink milk: 'Indirect concern'

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Amid bird flu spread, experts reveal if it's safe to drink milk: 'Indirect concern'

Traces of bird flu have been detected in pasteurized milk — leaving many people wondering if it’s safe to drink.

The U.S. Food and Drug Administration (FDA) released a notice on Thursday stating that one in five retail samples of commercial milk tested positive for fragments of highly pathogenic avian influenza (HPAI), more commonly known as bird flu or avian flu.

The share of milk with viral remnants was higher in areas where herds of cattle had been infected.

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The presence of the virus in the milk doesn’t necessarily mean there is a risk to consumers, however, the FDA noted.

“Additional testing is required to determine whether an intact pathogen is still present and if it remains infectious, which would help inform a determination of whether there is any risk of illness associated with consuming the product,” the agency stated.

Traces of bird flu have been detected in pasteurized milk, leaving many people wondering if it’s safe to drink. (iStock)

“Although bird flu viruses do not normally infect humans, sporadic human infections have occurred,” the FDA stated in the alert.

Pasteurization eliminates risk, experts say

Before milk can be sold commercially, government regulations require that it is pasteurized.

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During the pasteurization process, raw milk is heated to a certain temperature for a brief period of time and is then chilled again, according to the International Dairy Foods Association (IDFA) website.

This process kills any pathogens and ensures that milk is safe to drink.

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Dr. Scott Pegan, professor of biomedical sciences at the University of California, Riverside and a biochemist for the United States Medical Research Institute of Chemical Defense, said the FDA’s finding does not mean there is any direct risks to consumers.

“In the U.S., commercial intrastate sold milk is required to be pasteurized,” he told Fox News Digital. “This process is geared to kill viruses like H5N1 and other bacteria that can pose a threat to human health.”

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Milk pasteurization

A milk pasteurization system is shown at a food and drink exhibition. Pasteurization is a process that kills microbes in food and drink, such as milk, juice, canned food and others. (iStock)

“Milk that has been pasteurized is safe and there is no current reason to avoid it or other pasteurized milk products based on the FDA’s findings,” Pegan went on. 

“However, there is a substantial risk of consuming unpasteurized milk and products of that milk.”

Even after viruses and bacteria have been killed in pasteurized milk, remnants can remain in the milk, he said — but they are not dangerous.

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Edward Liu, M.D., chief of infectious diseases at Hackensack Meridian Jersey Shore University Medical Center in New Jersey, agreed that there is not a risk associated with drinking pasteurized milk.

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“The pasteurization is the key — the heat treatment kills off the viruses,” he told Fox News Digital. “Although the FDA’s testing picked up fragments [of the virus], the heating process destroyed it, so it’s not able to infect people.”

Dairy cows

The share of milk with viral remnants was higher in areas where herds of cattle had been infected. (iStock)

The fragments alone are not enough to cause any kind of infection, he confirmed.

“I think the key word is ‘fragments.’ Just like with COVID, if you do a PCR test a month later, we’ll detect little fragments of the virus, but it’s not active anymore,” Liu said. 

“So if the virus isn’t entirely intact, it shouldn’t be able to infect you.”

Any sporadic cases of human infection would likely occur when a farmer is handling birds directly, Liu said.

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Consumers should avoid drinking raw milk that has not been pasteurized, the FDA said.

“There are some people who like to go all natural, but pasteurization has been used for decades for safety,” he said. “Some degree of processing is actually better and safer for us.”

Animals pose greater concern, experts say

The “indirect concern” within the scientific and medical community involves the increased risk of “spillover” to humans from animals with the H5N1 virus, said Pegan. 

“Prior to the outbreak in dairy cattle, this concern principally revolved around the risk of transmission to humans from wild birds or poultry,” he told Fox News Digital.

Bird flu vaccine

The “indirect concern” within the scientific and medical community involves the increased risk of “spillover” to humans from animals with the H5N1 virus, one expert said. (REUTERS/Dado Ruvic/Illustration/File Photo)

“The presence of H5N1 avian flu in the milk of these cattle shows that cattle may be able to provide a new reservoir for this virus, increasing the odds of exposure to those in direct contact with the infected cattle.”

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The more animals that are infected, the higher chance that humans may come in direct contact with the virus — which likely would lead to a greater number of human cases, said Pegan. 

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“The case of cattle-to-human transmission seen in Texas is in line with this concern,” he noted. 

“Also, the more mammals infected increases the chances that the virus will adapt to other mammals, such as humans.”

FDA’s recommendations

The FDA restated its “long-standing recommendation” that consumers avoid drinking raw milk that has not been pasteurized. 

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The agency also recommends that companies refrain from manufacturing or selling raw milk or raw milk products made with milk from cows that tested positive for bird flu, were exposed to the virus or showed symptoms of illness.

“Over the past few years, there has been an increased consumer demand for these unpasteurized products,” Pegan said. 

Cows and milk

The FDA restated its “long-standing recommendation” that consumers avoid drinking raw milk that has not been pasteurized.  (iStock)

“While not allowed to be sold via interstate brands, some states have relaxed local sales of these products at farmer’s markets and similar outlets,” he said. 

“Individuals may want to avoid those unpasteurized products until more information is obtained about this H5N1 avian flu outbreak in dairy cattle.”

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The FDA also urged producers to “take precautions” when discarding milk from affected cows, “so that the discarded milk does not become a source of further spread.”

So far, only one person has been confirmed to have contracted the virus after exposure to infected cows, the FDA stated.

“The CDC says the risk to the general public remains low,” the agency said.

“The FDA and USDA continue to indicate that, based on the information we currently have, our commercial milk supply is safe.”

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Fox News Digital reached out to the National Milk Producers Federation, the American Dairy Association and the International Dairy Foods Association for comment.

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

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New Jersey woman recovering after receiving successful pig kidney transplant

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New Jersey woman recovering after receiving successful pig kidney transplant
  • Lisa Pisano faced heart and kidney failure, rendering her ineligible for traditional transplants, but a pioneering procedure at NYU Langone Health offered hope.
  • Doctors implanted a mechanical heart pump to stabilize Pisano’s failing heart, followed by a kidney transplant from a genetically modified pig.
  • Pisano’s recovery is progressing well, marking a significant advancement in animal-to-human transplantation.

Doctors have transplanted a pig kidney into a New Jersey woman who was near death, part of a dramatic pair of surgeries that also stabilized her failing heart.

Lisa Pisano’s combination of heart and kidney failure left her too sick to qualify for a traditional transplant, and out of options. Then doctors at NYU Langone Health devised a novel one-two punch: Implant a mechanical pump to keep her heart beating and days later transplant a kidney from a genetically modified pig.

Pisano is recovering well, the NYU team announced Wednesday. She’s only the second patient ever to receive a pig kidney — following a landmark transplant last month at Massachusetts General Hospital – and the latest in a string of attempts to make animal-to-human transplantation a reality.

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This week, the 54-year-old grasped a walker and took her first few steps.

Lisa Pisano looks at photos of her dog after her surgeries at NYU Langone Health in New York on April 22, 2024. Doctors transplanted a pig kidney into Pisano, who was near death, part of a dramatic pair of surgeries that also included a fix for her failing heart. (AP Photo/Shelby Lum)

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“I was at the end of my rope,” Pisano told The Associated Press. “I just took a chance. And you know, worst case scenario, if it didn’t work for me, it might have worked for someone else and it could have helped the next person.”

Dr. Robert Montgomery, director of NYU Langone Transplant Institute, recounted cheers in the operating room as the organ immediately started making urine.

“It’s been transformative,” Montgomery said of the experiment’s early results.

But “we’re not off the hook yet,” cautioned Dr. Nader Moazami, the NYU cardiac surgeon who implanted the heart pump.

“With this surgery I get to see my wife smile again,” Pisano’s husband Todd said Wednesday.

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Other transplant experts are closely watching how the patient fares.

“I have to congratulate them,” said Dr. Tatsuo Kawai of Mass General, who noted that his own pig kidney patient was healthier overall going into his operation than NYU’s patient. “When the heart function is bad, it’s really difficult to do a kidney transplant.”

THE PIG ORGAN QUEST

More than 100,000 people are on the U.S. transplant waiting list, most who need a kidney, and thousands die waiting. In hopes of filling the shortage of donated organs, several biotech companies are genetically modifying pigs so their organs are more humanlike, less likely to be destroyed by people’s immune system.

NYU and other research teams have temporarily transplanted pig kidneys and hearts into brain-dead bodies, with promising results. Then the University of Maryland transplanted pig hearts into two men who were out of other options, and both died within months.

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Mass General’s pig kidney transplant last month raised new hopes. Kawai said Richard “Rick” Slayman experienced an early rejection scare but bounced back enough to go home earlier this month and still is faring well five weeks post-transplant. A recent biopsy showed no further problems.

A COMPLEX CASE AT NYU

Pisano is the first woman to receive a pig organ — and unlike with prior xenotransplant experiments, both her heart and kidneys had failed. She went into cardiac arrest and had to be resuscitated before the experimental surgeries. She’d gotten too weak to even play with her grandchildren. “I was miserable,” the Cookstown, New Jersey, woman said.

A failed heart made her ineligible for a traditional kidney transplant. But while on dialysis, she didn’t qualify for a heart pump, called a left ventricular assist device or LVAD, either.

“It’s like being in a maze and you can’t find a way out,” Montgomery explained — until the surgeons decided to pair a heart pump with a pig kidney.

TWO SURGERIES IN EIGHT DAYS

With emergency permission from the Food and Drug Administration, Montgomery chose an organ from a pig genetically engineered by United Therapeutics Corp. so its cells don’t produce a particular sugar that’s foreign to the human body and triggers immediate organ rejection.

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Plus a tweak: The donor pig’s thymus gland, which trains the immune system, was attached to the donated kidney in hopes that it would help Pisano’s body tolerate the new organ.

Surgeons implanted the LVAD to power Pisano’s heart on April 4, and transplanted the pig kidney on April 12. There’s no way to predict her long-term outcome but she’s shown no sign of organ rejection so far, Montgomery said. And in adjusting the LVAD to work with her new kidney, Moazami said doctors already have learned lessons that could help future care of heart-and-kidney patients.

Special “compassionate use” experiments teach doctors a lot but it will take rigorous studies to prove if xenotransplants really work. What happens with Pisano and Mass General’s kidney recipient will undoubtedly influence FDA’s decision to allow such trials. United Therapeutics said it hopes to begin one next year.

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