Childhood vaccine exemptions are at an all-time high. Doctors worry diseases like measles could return

Childhood vaccine exemptions are at an all-time high. Doctors worry diseases like measles could return
Childhood vaccine exemptions are at an all-time high. Doctors worry diseases like measles could return
Евгения Матвеец/Getty Images

(NEW YORK) — Exemptions for immunizations required in school are on the rise in the U.S., leading to concerns among medical experts that diseases like measles could soon make a comeback in many states.

In November, the Centers for Disease Control and Prevention reported that exemptions for immunizations required in school is the highest ever recorded in U.S. history – increasing to an average 3.0% in the 2022-2023 school year, with 10 states now reporting exemptions exceeding 5%. This leaves both vaccinated and unvaccinated children vulnerable to disease outbreaks including measles, experts say.

“There’s 9 million people in this country who can’t be vaccinated. They depend on those around them to protect them,” Dr. Paul Offit, a virologist and vaccine advocate, told ABC News.

In his upcoming book, “Tell Me When It’s Over: An Insider’s Guide to Deciphering Covid Myths and Navigating Our Post-Pandemic World,” Offit gives a historical account of the anti-vaccination movement in the U.S. and explains the rise of non-medical immunization exemptions over time and how these trends relate to the nationwide pushback against COVID-19 vaccine mandates.

ABC News spoke with Offit and other doctors who work in infectious diseases and immunization research to explore what’s driving these trends and understand what the future may hold if immunization exemptions keep rising.

“We mandated vaccines – for the first time in my lifetime at all levels,” Offit said. “And that really upset people … people really pushed back, they were angry.”

Since the start of the COVID-19 pandemic, lawmakers have introduced hundreds of pieces of legislation aimed at rolling back vaccine mandates, largely COVID-19 mandates, but some changes have also impacted childhood immunization requirements.

These legislative efforts largely prevented many statewide COVID-19 vaccine mandates, according to the National Academy for State Health Policy. Since the pandemic began, no state has passed legislation to newly allow a philosophical or religious exemption in the few states that only allow medical exemptions, according to the National Conference of State Legislatures. But in some states, new laws or court rulings have made getting routine vaccines harder.

In July 2021, pushback against COVID-19 vaccines started to spill over to routine childhood immunizations in Tennessee. Efforts to vaccinate more of the state’s population against COVID-19, including teenagers, led to the firing of the state’s medical director, Dr. Michelle Fiscus, and temporarily halted all immunizations to kids and teens in the state. As of May 2023, Tennessee law now requires written informed consent by a parent or legal guardian for any person under the age of 18 to receive any vaccine.

Critics worry this added step of written consent creates an unnecessary barrier that may prevent many kids from getting the shots they need, including some of the most vulnerable kids such as cancer patients who often need extra doses of routine vaccines to mount a full immune response.

Dr. Diego R. Hijano, an infectious disease specialist at St. Jude Children’s Research Hospital in Memphis, Tennessee, told ABC News that this new law doesn’t make vaccines safer, it just makes it harder for parents to agree to vaccines and harder for providers to administer them on time.

“We still do all the things we need to do before the law is implemented. It’s just that this step has delayed us being able to offer all these vaccines under the new law because we’ve had to create these consents and have all this [new process] in place,” Hijano said.

Mississippi is not known for being a national leader in public health outcomes – holding higher rates of obesity, diabetes, heart disease, and infant and maternal mortality than national averages – however, the state’s childhood vaccine rates are an exception.

The CDC reports that Mississippi still holds the highest proportion of vaccinated kindergarteners in the country, but health officials worry these high rates may soon be threatened by the recent court order that went into effect in July 2023 requiring the health department to allow religious exemptions, the Associated Press reported.

“The federal [Covid-19 vaccine] mandates were not we received in many places like ours, and some of that bled over into any type of [vaccine] mandate,” Dr. Daniel Edney, state health officer for the Mississippi Department of Health told ABC news. “This is a situation where it’s extremely frustrating, as the chief public health official and physician, to have 40 years of public health policy and science overruled by two attorneys who don’t [have public health expertise].”

Edney says that Mississippi typically has about 500 medical exemptions a year, but now, they have had over 2,100 non-medical exemptions since July and expect to pass 3,000 total exemptions before the year is over. Currently and concerningly, Edney says non-medical exemptions have been concentrated in a handful of counties in the state that include Hinds County, Ridgeland County, Lamar County, and in some pockets on the Gulf Coast.

Vaccine-preventable outbreaks like measles, polio, and whooping cough are far more likely in areas that have concentrated clusters of unvaccinated people, and since no vaccine is 100% effective, people who are vaccinated can also get sick.

Edney said Mississippi has been fortunate not to need the same level of staffing and resources dedicated to respond to vaccine-preventable disease outbreaks like other states more prone to these outbreaks have, but health officials say that has to change now.

“We have to invest in these investigation [resources] for the outbreaks that will come at some point down the road,” Edney said.

Measles cases drove California to tighten vaccine restrictions

Doctors worry that the only thing that will drive this rising trend of non-medical vaccine exemptions in the opposite direction will be disease outbreaks that predominantly affect young children, which was seen in California after there was a large measles outbreak that began at Disneyland from December 2014 to February 2015.

Dr. Dean Blumberg, professor and chief of pediatric infectious diseases at UC Davis Children’s Hospital explained to ABC News that California previously allowed both philosophical and religious vaccine exemptions, but now has some of the strictest vaccine laws in the country through state legislation passed in 2016 and 2019, which only allows medical exemptions that the health department reviews.

“I think vaccines are always at some level a victim of their own success,” Offit said. “It just scares me that the only way we’re going to once again appreciate the importance of vaccines is to, at some level, experience some of these diseases again. I just wish we could do something to avoid that.”

What parents need to know

Vaccine preventable diseases can be deadly, which is why vaccines were developed to prevent them. Globally every year, 134,200 kids still die from measles, according to the CDC. The agency also estimates that failure to eradicate polio could cause poliovirus to reappear around the world with an estimated 150,000-200,000 new cases expected every year within 10 years.

“For all these diseases, there’s reasons that a lot of effort was made to develop these vaccines and deliver the vaccine. And for each individual one, I think it’s important for parents to know that if their kids are not vaccinated there are potentially very serious consequences,” Blumberg said.

Blumberg encourages healthcare providers to discuss the importance of vaccines and the consequences of not getting a child vaccinated as much as possible to parents and caregivers. “Lately, what I found is most useful is talking about each individual vaccine and talking about why it fits into the vaccine schedule, where it is, and what the consequences are of having children vulnerable to these vaccine preventable diseases,” Blumberg said.

Doctors also point out that a rate of 3% of immunizations exemptions still means 97% of kids in school are getting vaccines on time.

“The vast majority of parents are still vaccinating their kids according to the recommended schedule,” Dr. Sean O’Leary, chair of the American Academy of Pediatrics Committee on Infectious Diseases and professor of pediatrics at the University of Colorado Anschutz Medical Campus/Children’s Hospital Colorado, told ABC News.

O’Leary points out that while vaccines have been used as political tools in recent years, most parents care more about what their medical provider says than any politician. Talking to parents at health visits about the importance of vaccines is important.

“The vast majority of people really are not operating in the political arena, when they’re when they’re thinking about their own children,” O’Leary said. “[Parents are] operating in what is best for my child.”

Dr. Jade A Cobern, MD, MPH, is a board-certified pediatrician specialized in general preventive medicine and is a member of the ABC News Medical Unit.

 

Copyright © 2023, ABC Audio. All rights reserved.

Counterfeit Ozempic found in US drug supply, FDA warns

Counterfeit Ozempic found in US drug supply, FDA warns
Counterfeit Ozempic found in US drug supply, FDA warns
Zave Smith/Getty Images

(NEW YORK) — As Ozempic and other drugs used for weight loss continue to soar in popularity, the U.S. Food and Drug Administration (FDA) has issued a new warning for consumers.

On Thursday, the FDA announced it had seized “thousands of units” of counterfeit Ozempic from the U.S. drug supply.

The agency warned consumers, as well as wholesalers, retail pharmacies and health care workers, to check Ozempic products, noting, “Some counterfeit products may still be available for purchase.”

Ozempic, made by Novo Nordisk, is approved by the FDA to treat Type 2 diabetes, but some doctors prescribe the medication “off-label” for weight loss. Ozempic is an injectable medication that is typically prescribed to be taken once per week.

The active ingredient in Ozempic is semaglutide, a medication that also was initially approved for Type 2 diabetes but which the FDA has since approved for use in weight management under the brand name Wegovy. Like Ozempic, Wegovy is also manufactured by Novo Nordisk.

In its warning, the FDA said consumers and healthcare workers should not “distribute, use, or sell” one-milligram injectable Ozempic products with the lot number NAR0074 and serial number 430834149057.

In addition, the FDA said that needles on the affected products are also counterfeit.

“Accordingly, the sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use the counterfeit products,” the agency said. “Based on analyses completed to date, other confirmed counterfeit components within the seized products are the pen label, accompanying health care professional and patient information, and carton.”

According to the FDA, there have so far been five “adverse events” from the affected products. The agency said none of events are “serious” and noted the reported complications have been consistent with the standard side effects of drugs used for weight loss, including Ozempic, which include nausea, vomiting, diarrhea, abdominal pain and constipation.

The agency said it is continuing the investigation and is working with Novo Nordisk to “identify, investigate, and remove further suspected counterfeit semaglutide injectable products found in the U.S.”

Consumers and healthcare workers are asked to report adverse events or side effects from Ozempic use via the FDA’s website.

Consumers can also report suspected counterfeit products to their state’s FDA consumer complaint coordinator or directly to the FDA via their website. You can also call Novo Nordisk about Ozempic concerns at 1-800-727-6500.

The FDA’s warning about counterfeit Ozempic comes nearly seven months after the agency warned consumers that off-brand forms of drugs being used for weight loss could be unsafe.

The agency issued the warning in June as many people have reported turning to compounding pharmacies to get cheaper doses of semaglutide. Without insurance coverage, the cost of medications like Ozempic can run more than $1,000 a month.

Compound versions of drugs are made for individual patients using raw ingredients. The FDA said at the time it had received reports of adverse events after people administered semaglutide that was made by a compounding pharmacy. The FDA did not specify the number of reports, nor what the adverse events were.

“Patients should not use a compounded drug if an approved drug is available to treat a patient. Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality,” the FDA said in a new safety warning this week.

 

Copyright © 2023, ABC Audio. All rights reserved.

Record number of Americans have signed up for Obamacare this year, HHS says

Record number of Americans have signed up for Obamacare this year, HHS says
Record number of Americans have signed up for Obamacare this year, HHS says
ATU Images/Getty Images

(NEW YORK) — A record number of Americans have signed up for health insurance through Affordable Care Act (ACA) marketplaces this year, according to early data published by the Biden administration this week.

More than 15 million people have enrolled in 2024 coverage under the ACA — often called by its nickname, Obamacare — as of Dec. 15, which is 33% higher than the roughly 11 million who did so last year.

This figure includes those who have bought insurance through state-based marketplaces or at HealthCare.gov, the website run by the federal government.

The Department of Health & Human Services said it expects more than 19 million to enroll by the deadline of 5 a.m. ET on Jan. 17, 2024 — about 7 million more people than when President Joe Biden took office. Their coverage will begin on Feb. 1.

On Dec. 15 alone, more than 745,000 enrolled in plans on HealthCare.gov. Health officials said it was the highest number of visitors ever recorded since the portal rolled out in 2013.

“Millions of Americans signing up for health care coverage under the Affordable Care Act is good news. It means more Americans have the peace of mind of knowing that going to the doctor won’t empty their bank account,” HHS Secretary Xavier Becerra said in a statement. “The Biden-Harris Administration will continue working to expand health care coverage and lower prescription drug costs, so taking care of your health is not a luxury.”

HHS did not immediately reply to ABC News’ request for comment.

One reason for increased enrollment is likely due to millions of Americans losing Medicaid, a government program that provides health insurance for adults and children with low incomes.

During the COVID-19 pandemic, when the government issued its two emergencies, states were not allowed to delist people so nearly 95 million people received coverage through Medicaid by the end of March 2023, according to nonprofit KFF.

States were also given additional federal funding for the last three years to provide continuous Medicaid coverage, ensuring no one lost health care amid the throes of COVID-19.

When the Biden administration ended both the COVID-19 national emergency and public health emergency on May 11 of this year, states began reviewing their rolls to see if enrollees were still eligible for government-funded health care.

More than 13.3 Medicaid enrollees have been removed as of Dec. 20, according to KFF. The nonprofit believes this is actually an undercount due to lags in state data.

Another reason for the increased enrollment could be the number of people who became uninsured under former President Donald Trump’s administration. Gallup data shows that in 2019, 13.7% of adults were without health insurance.

While this is lower than the percentage of Americans that were without health insurance before the ACA, the Trump administration ended cost-sharing reduction, rolled back the individual mandate penalty and cut back on enrollment outreach, according to Gallup.

Trump has vowed to replace the ACA with his own health care plan if elected president again.

Despite the record enrollment, more than 25.6 million non-elderly Americans were uninsured in 2022, according to KFF. HHS says the Biden administration “continues to make increasing coverage a top priority” through provisions in the Inflation Reduction Act that result in savings and a competitive marketplace.

ABC News’ Cheyenne Haslett contributed to this report.

 

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Respiratory viruses increasing as Americans prepare to gather for the holidays: CDC

Respiratory viruses increasing as Americans prepare to gather for the holidays: CDC
Respiratory viruses increasing as Americans prepare to gather for the holidays: CDC
Ekaterina Goncharova/Getty Images

(NEW YORK) — Respiratory virus season has kicked off in the United States as Americans get ready to travel to celebrate the holidays.

Flu and COVID-19 emergency department visits and hospitalizations are continuing to increase throughout the United States, while vaccination rates lag, according to data from the Centers for Disease Control and Prevention.

Respiratory syncytial virus, or RSV, levels are still elevated in many areas of the country, although CDC data shows the weekly percent of total emergency department visits associated with RSV appears to be trending down after hitting its peak around Thanksgiving.

“[This is] good, so we don’t have necessarily peaking of all of these simultaneous threats at the same time,” said Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hospital, and an ABC News contributor. “At the same time, we are seeing a jump in COVID, which is not ideal because a new COVID variant, aligning with holiday travel and gatherings, is unfortunately [a] recipe for additional illness.”

On Tuesday, the World Health Organization listed the JN.1 COVID variant — a subvariant of the omicron variant — as a “variant of interest.” It is currently estimated to account for 21% of new cases in the U.S., according to the CDC.

There is currently no evidence to show that JN.1 causes more severe disease or that currently available treatments and vaccines are ineffective against the variant.

Countries in the midst of winter, such as the U.S., could see an increase in respiratory infections, the WHO said in a statement.

“That will unfortunately, over time, create some pressure on our health system,” Brownstein said.

Some health systems in the U.S. are reinstating mask mandates due to the rise in respiratory viruses as they deal with an influx of patients.

UW Health, which primarily serves Wisconsin and northern Illinois, posted on X, formerly known as Twitter, on Tuesday that all staff, patients and visitors will be required to wear masks for patient interactions in clinic settings “due to expected seasonal increase and sustained high volume of respiratory illness.”

Additionally, on Wednesday, masks became required at all University of Pittsburgh Medical Center facilities, according to Pittsburgh ABC affiliate WTAE. UPMC said cases would be monitored and protocols adjusted as necessary.

CDC Director Dr. Mandy Cohen recently told ABC News that, for the most part, pediatric hospitals have told the federal health agency they’ve been able to manage treating patients.

Brownstein said more hospitals may reinstate mask mandates in the coming weeks if cases do, in fact, rise following the holidays, but echoed Cohen’s comments that hospitals have become better equipped to anticipate potential surges of patients.

“Hospitals have done a lot more to understand how to deal, especially with a new element of COVID as part of the seasonal mix,” Brownstein said. “So, there is a lot more planning, forecasting and employee safety protocols, and it can ensure that hospitals are running at maximum capacity to handle a potential influx of patients.”

Brownstein said he recommends the same mitigation measures that health officials have throughout the pandemic for those who are traveling or hosting for the holidays, including proper hand hygiene, being up to date on vaccines, improving ventilation and potentially masking, based on your personal risk level.

“Each individual household gathering is going to have a different mix of high-risk groups and vulnerable individuals, and we want to prepare to make sure — especially for those that are potential, serious risk and complications — that we’re managing to overall reduce that risk,” he said. “This is a playbook that we have gone to many times before, and so even though the impact of COVID isn’t anywhere near where it used to be, everyone has the right tools to help reduce any potential risk of these respiratory pathogens heading into the holidays.”

ABC News’ Youri Benadjaoud contributed to this report.

Copyright © 2023, ABC Audio. All rights reserved.

Toss or save? How to avoid food poisoning over the holidays

Toss or save? How to avoid food poisoning over the holidays
Toss or save? How to avoid food poisoning over the holidays
Liliboas/Getty Images

(NEW YORK) — With the holidays approaching, many are looking forward to feasting with family and friends. Gatherings often bring a lot of homemade favorites — steaming turkey, glistening ham, tangy cranberry sauce and creamy eggnog. While preparing dishes, it’s important to follow safe cooking guidelines and limit the risk of food poisoning.

When it comes to serving dishes and dealing with leftovers, most people want to know what’s safe to eat and what needs to be tossed.

The New York State Departments of Agriculture and Markets recently issued recommendations for enjoying safe holiday feasts. The most important things to consider to avoid foodborne illness are safe storage, thawing and preparation.

When returning home with a fresh grocery haul, be sure to store away perishables as soon as possible. Leaving refrigerated and frozen food products out for extended periods of time allows for the growth of bacteria that can cause illness. Refrigerators should be set to 40°F or lower, and freezers should be set no higher than 0°F, per the FDA.

This time of year, many people purchase canned goods for cooking and to donate to food pantries. Experts recommend keeping these products in cool, dry spaces until opening and taking particular care not to leave them out on stovetops.

“Once that can is open, you really need to eat or refrigerate the contents after two hours,” says Dr. Donald Schaffner, PhD, a professor in the Department of Food Science at Rutgers University.

When thawing frozen meats, food safety specialists agree that the best method is to use the refrigerator or microwave just before cooking. Thawing meat in the refrigerator “makes sure that the food stays at a safe temperature during the thawing process,” according to Dr. Schaffner.

“As a piece of meat thaws, you may get juices running out of that piece of meat” that may contain different types of bacteria, creating a source of contamination. Submerging in hot water can also lead to the spread of bacteria into pots and bowls.

Washing hands when preparing food may seem obvious, but experts note that there is always a risk of cross-contamination when using the same knives and cutting boards for raw meat and other foods. Taking the time to wash these items with soap and hot water after handling raw meat can go a long way toward keeping the rest of a holiday feast safe to eat.

Safe cooking should also include a meat thermometer. A general rule of thumb is to cook to a minimum internal temperature of 140°F. Pork should be cooked to 150°F, ground beef to 160°F and poultry and leftovers to 165°F, per the Departments of Agriculture and Safety.

Eggs can be a forgotten source of contamination as well. According to guidelines from the Centers for Disease Control and Prevention, eggs need to be cooked thoroughly and raw forms should definitely be avoided. That means waiting until the cookies finish baking and not dipping into the raw batter.

As far as enjoying holiday cheer, Dr. Schaffner suggests, “The safest eggnog is the kind you buy from the grocery store, premade and pasteurized. If you’re going to make your own eggnog with raw eggs, you need to cook that eggnog.” Alcohol does not guarantee purification from salmonella, so those making it from scratch should follow a recipe that involves cooking, Schnaffer added.

Chris Medrano, MD, is a resident physician in Chicago and a member of the ABC News Medical Unit.

Copyright © 2023, ABC Audio. All rights reserved.

Five tips on how to maintain health and wellness during the holiday season

Five tips on how to maintain health and wellness during the holiday season
Five tips on how to maintain health and wellness during the holiday season
Somyot Techapuwapat/Getty Images

(NEW YORK) — As the holidays arrive and people attend gatherings with family and loved ones, many will stray from their daily routines but maintaining your health is possible.

“It is hard to stick with routines when on holiday because we are no longer in our day to day pattern,” Dr. Amanda Velazquez, director of obesity medicine at Cedars-Sinai Center for Weight Management and Metabolic Health, told ABC News.

She added, “A lot of gatherings are centralized around eating. This is part of our culture as human beings.”

Here are five expert tips on how to maintain health and wellness during the holiday season:

1. Do not intentionally skip meals in anticipation of a big meal

Many will forgo meals when expecting to consume large amounts of food in one sitting.

However, this is “Priming your body to be very hungry, overly hungry. Also, you will not give yourself the fuel and energy during the day to sustain yourself,” Dr. Velazquez says. Experts recommend having balanced meals throughout the day.

Consider eating a quick and healthy snack before a large meal to help curb your hunger. Foods higher in fiber and protein will keep you more full.

2. Be mindful of what you drink

Liquid calories can be deceiving as energy-containing drinks are generally less satiating than solid foods.

“Try to minimize empty calories and avoid sugar sweetened beverages such as sodas, juices, and high calorie cocktails,” Dr. Velazquez says.

In addition, alcohol not only contains calories on its own but it may also increase appetite. Therefore, it is important to ensure you are consuming beverages in moderation over the holidays.

3. Propose a group fitness activity.

Doing things with others can be more motivating and fun than doing it on your own.

“I try to encourage patients to think about who are members of their families or friends who may want to participate in physical activities. This usually leads to them brainstorming about partnerships and keeps them accountable,” Dr. Velazquez says.

Fun activities to consider include yoga, hiking, going for walks and sports.

4. Take short mental health breaks

Keeping up with holiday demands can be stressful, experts say. Stress hormones can increase appetite and lead to weight gain, according to research published in the American Journal of Epidemiology. Stress causes cravings for unhealthy foods such as fast foods, snacks, and calorie-dense foods.

Consider utilizing self-care strategies like meditation, breathing exercises, journaling, yoga, and physical exercise to minimize stress.

Having someone you can talk to openly and genuinely can also be therapeutic, experts say.

5. Prioritize sleep

Per the National Institutes of Health, quality sleep can improve your brain performance, mood and overall health. Experts recommend that adults get seven to nine hours of sleep a night.

A consistent sleep schedule can help, according to the Centers for Disease Control and Prevention. So can ensuring that you have a quality sleep environment with minimal distractions including noise and light, and avoiding caffeine, nicotine and alcohol in the afternoon and evening.

Lastly, avoid screen time before bed as blue light can disrupt sleep.

Edward King, MD, is a member of the ABC News Medical Unit.

Copyright © 2023, ABC Audio. All rights reserved.

Federal judge says research can’t be used to link acetaminophen to autism, ADHD

Federal judge says research can’t be used to link acetaminophen to autism, ADHD
Federal judge says research can’t be used to link acetaminophen to autism, ADHD
George Frey/Bloomberg via Getty Images

(NEW YORK) — The 440 lawsuits brought against the makers of Tylenol and generic acetaminophen do not have “admissible evidence” to show that prenatal exposure to the medication can lead to autism or ADHD, a federal judge ruled this week.

U.S. District Judge Denise Cote wrote in her opinion that at least one of the experts provided by the plaintiffs “cherry-picked and misrepresented study results and refused to acknowledge the role of genetics in the etiology of either ASD or ADHD.”

The ruling is largely consistent with the position of major medical bodies, which say the evidence is not sufficient to make a cause-and-effect link between the use of acetaminophen during pregnancy and issues like autism and ADHD in children.

The U.S. Food and Drug Administration (FDA) says women should talk to their doctors before taking any medications during pregnancy or if they are planning to become pregnant.

Copyright © 2023, ABC Audio. All rights reserved.

Recalled applesauce contaminated with lead linked to more than 200 cases: CDC

Recalled applesauce contaminated with lead linked to more than 200 cases: CDC
Recalled applesauce contaminated with lead linked to more than 200 cases: CDC
Jamie Grill/Getty Images

(NEW YORK) — After a monthslong investigation by the U.S. Food and Drug Administration into applesauce pouches tainted with lead, the agency suspects the contaminated products were the result of a manufacturer cutting corners to save money, according to a senior U.S. official.

The official spoke to ABC News on condition of anonymity in order to discuss details of the ongoing internal investigation.

“They think the company deliberately sourced cheap materials,” the official told ABC News of the FDA’s latest findings.

The Centers for Disease Control and Prevention reported more than 205 total confirmed and probable cases as of Dec. 20, though that number may also include cases counted separately by the FDA.

Politico first reported on Friday that a top FDA official said a leading theory is that the tainted applesauce was an “intentional” act.

“The FDA can confirm that one of the theories the agency is exploring regarding the high lead levels in the recalled cinnamon applesauce pouches is the potential that the cinnamon contamination occurred as a possible result of economically motivated adulteration,” the agency said in a statement. “As this is an ongoing investigation, the FDA can only confirm this is one of the theories at this time.”

A second official told ABC News that not following safety protocols would be seen by regulators as intentional.

The FDA first advised parents and caregivers in an Oct. 28 health alert not to buy or give children WanaBana apple cinnamon fruit puree pouches “because the product may contain elevated levels of lead.”

The company announced the voluntary recall of its 2.5-ounce fruit puree pouches on Oct. 30, which was later expanded on Nov. 9 to include products from its private label brands Schnucks Apple Sauce 90g pouches with cinnamon and Weis Cinnamon Apple Sauce.

The FDA announced earlier this week there have been 65 reports of adverse events potentially linked to the recalled product in 27 states to date. Those reports included children younger than 1 and up to 6 years of age.

On Dec. 5, the FDA “initiated an onsite inspection at the Austrofoods facility located in Ecuador” where “ingredient sample collection is underway.”

In a Dec. 12 update, the agency said it was working with Ecuadorian authorities “to gather information about Negasmart, the supplier of the cinnamon to Austrofoods, including whether the cinnamon in the recalled products was used in other products exported to the United States.”

The FDA confirmed with Ecuadorian authorities at the time that, “of Negasmart’s direct customers, only Austrofoods ships product to the US.” The agency also confirmed that “Negasmart does not directly export products to the US.”

“Cinnamon samples collected from the lots used in recalled products will undergo laboratory analysis. FDA will update this advisory to share the sample results once the analysis is complete,” the FDA stated.

The FDA first announced the investigation into WanaBana when the agency was made aware of four children with elevated blood lead levels, indicating potential acute lead toxicity, by the North Carolina Department of Health and Human Services and the North Carolina Department of Agriculture & Consumer Services.

Less than a week later, the investigation was transferred to the FDA’s Coordinated Outbreak Response & Evaluation Network in collaboration with the CDC. Two additional brands were added to the recall in the Nov. 3 update: Schnucks cinnamon-flavored applesauce and Weis cinnamon applesauce pouches.

The North Carolina Department of Health and Human Services investigation initially identified the products “as a potential shared source of exposure,” the FDA said at the time, citing analysis that detected “extremely high concentrations of lead.” At that time, the firm agreed to voluntarily recall all WanaBana apple cinnamon fruit puree pouches regardless of expiration, per the FDA.

“FDA is aware that recalled WanaBana Apple Cinnamon Puree is still on the shelves at several Dollar Tree stores in multiple states,” the FDA said. “FDA is working with the firm to ensure an effective recall.”

Austrofood was asked by the Ecuadorian government to suspend all activities since Nov. 15, 2023, according to the National Agency of Health Regulation, Control and Surveillance.

The agency told ABC News it is aware of the situation and issues regarding the Pichincha-based food manufacturer and the Ecuadorian government through the National Agency of Health Regulation, Control and Surveillance has started an investigation independent from the FDA.

Officials in Ecuador also confirmed that the level of lead was above the regular numbers. The issue is in the cinnamon powder only.

Ecuador is currently preparing to withdraw a mango compote sample that used the same cinnamon powder as Wanabana, officials said.

“This is people trying to save money,” Dr. Donald W. Schaffner, a professor at Rutgers University and specialist in food science, told ABC News. “Obviously there is a recall out there; people should check their cupboards and make sure you don’t have any of these products.”

“If you think you may have been feeding your kid these products, get your kid to the doctor and get them tested,” he added.

Signs and symptoms of lead toxicity

Experts say it can be difficult to detect lead exposure in kids, because sometimes there are no obvious signs.

However, the FDA says symptoms of short-term lead exposure can include headache, abdominal pain and vomiting, with longer-term exposure symptoms also potentially including fatigue, irritability, constipation, muscle aches or a sensation of prickling/burning.

Lead exposure can only be properly diagnosed via a blood sample, according to the CDC. The FDA says anyone who notices possible lead poisoning symptoms should contact their doctor immediately.

Copyright © 2023, ABC Audio. All rights reserved.

COVID variant JN.1 listed as ‘variant of interest’ by World Health Organization

COVID variant JN.1 listed as ‘variant of interest’ by World Health Organization
COVID variant JN.1 listed as ‘variant of interest’ by World Health Organization
Scott Olson/Getty Images

(NEW YORK) — A COVID variant known as JN.1 has been listed as a separate “variant of interest” by the World Health Organization (WHO).

The omicron sub variant was previously classified under its parent strain, BA.2.86, which prompted concern among some scientists earlier this year due to its high number of mutations.

There is no evidence that JN.1 causes any more severe disease, and existing tests, vaccines and treatments are still expected to work, experts say.

“We know that the COVID virus continues to change. And even in the last few weeks, it has changed again,” Dr. Mandy Cohen, the director of the Centers for Disease Control and Prevention (CDC), told ABC News.

“The good news is that, that new change to the virus…one, we can still pick it up with our tests. Two, our treatments are still effective against that change. And importantly, the updated COVID vaccine that you can get right now is still good coverage for those changes – we’ve seen that in the lab,” Cohen added.

Variants are listed under three separate categories by the WHO: variants of concern, which is the highest level; variants of interest; and variants under monitoring.

JN.1 now joins other Omicron sub variants such as XBB.1.5, XBB.1.16, EG.5, and BA.2.86 on the list of variants of interest.

The JN.1 variant is currently estimated to account for 21% of new cases in the U.S., according to the CDC. The Northeast is the area with the highest proportion of variant infections, where it accounts for an estimated 32% of new COVID cases.

The public health risk of the JN.1 variant is low, according to the WHO. Even so, countries that are currently in the middle of winter, like the U.S., could see an increase in respiratory infections, the agency acknowledged.

“As we observe the rise of the JN.1 variant, it’s important to note that while it may be spreading more widely, there is currently no significant evidence suggesting it is more severe or that it poses a substantial public health risk,” said John Brownstein, Ph.D., chief innovation officer at Boston Children’s hospital and an ABC News medical contributor.

Experts urge caution as family and friends are expected to gather for the holidays, which are often followed by a rise in respiratory illnesses.

“We should continue to practice safety measures to reduce transmission, especially as the rise of this variant will likely be accelerated by upcoming holiday travel and gathering,” Brownstein said.

“I know everyone’s tired of COVID, but it is still here with us. It’s still changing, and we still need to stay ahead of it,” Cohen said.

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Some people opt to pause drugs used for weight loss over the holidays. Is it safe?

Some people opt to pause drugs used for weight loss over the holidays. Is it safe?
Some people opt to pause drugs used for weight loss over the holidays. Is it safe?
bymuratdeniz/Getty Images

(NEW YORK) — For many people, the holiday season is a time of holiday feasting, from dinners to cocktail parties and special desserts.

Amid all the celebrating, some people like Julie Kelly, a 41-year-old from North Carolina, are opting to hit pause on the medications they take to help them lose weight, drugs like Ozempic, Wegovy and Mounjaro.

Kelly, who has lost 38 pounds by taking semaglutide, the active ingredient in Ozempic and Wegovy, told “Good Morning America” that she skipped her dose of semaglutide over the Thanksgiving holiday, and is doing the same around Christmas. She said the break helps her feel less uncomfortably full at meals and brings up fewer questions from friends and family about what she is, or is not, eating.

“What I noticed was I was still able to eat the things that I really wanted, to indulge a little bit,” Kelly said of her experience over Thanksgiving. “I just had to be really conscious about how I was feeling, what I was eating, how fast I was eating it.”

Over the past year, use of drugs that can lead to weight loss has skyrocketed in popularity.

Both Ozempic and Mounjaro are approved by the U.S. Food and Drug Administration to treat Type 2 diabetes, but some doctors prescribe the medication “off-label” for weight loss, as is permissible by the FDA.

Wegovy is FDA-approved for weight loss.

Ozempic, Wegovy and Mounjaro require a prescription and are not sold over the counter.

In November, the FDA approved another drug, known as Zepbound, as a weight loss management treatment for people with obesity, or those who are overweight with at least one related underlying condition, such as high blood pressure. As a diabetes drug, it is sold under the brand name Mounjaro, as the two medications contain the same active ingredient, tirzepatide.

Clinical studies show users of the medications can lose between 5% and 20% of their body weight on the medications over time.

Caley Svensson, a 39-year-old from New Jersey, said she has lost 90 pounds on Mounjaro. During the holiday season, she said she is also opting to cut back on the medication, but for financial reasons.

Svensson said her prescription is not covered by insurance, so she pays more than $1,000 out-of-pocket total for four single-use doses. Over the holidays, Svensson said she is stretching her doses beyond the usual week so that she can use the money for other expenses, including Christmas presents.

“If I can stretch it for 10 days instead of every week, that helps me push off, you know, the expense a little bit,” Svensson told “GMA,” adding that by stretching out her doses, she can save a few “hundred extra dollars.”

On the flip side, when Oprah Winfrey revealed earlier this month that she is using a medication to help her maintain her weight loss, she said she took the medication strategically prior to Thanksgiving to help her eat less.

“I knew I was going to have two solid weeks of eating, and instead of gaining eight pounds like I did last year, I gained half a pound,” she told People magazine. “It quiets the food noise.”

Ozempic, Wegovy and Mounjaro are all injectable medications that are typically prescribed to be taken once per week.

Side effects of the drugs can include severe nausea, vomiting, diarrhea and constipation.

Dr. Veronica Johnson, an obesity medicine specialist at Northwestern Medicine, told “GMA” that while there are no known long-term side effects of pausing and restarting the medications, doing so may lead to increased side effects such as increased appetite and nausea, as well as weight gain.

“If a patient skips their medication for one to two weeks, there is a potential for them to have some increased side effects,” said Johnson, who does not treat Winfrey, Svensson or Kelly. “They might not see those improvements in their hunger and appetite, and so they’ll inevitably eat more and that may contribute to some weight gain.”

It is advised to consult a physician before stopping weight loss medications to minimize the risk of side effects.

 

 

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