Health

(NEW YORK) — When Tara Rothenhoefer sits down at the Thanksgiving table this year, she said she envisions being able to enjoy herself rather than feel stressed about the food on the table.

Rothenhoefer said she attributes that change to Mounjaro, a medication that she said has helped her lose more than 200 pounds.

Prior to taking Mounjaro, Rothenhoefer said at a holiday like Thanksgiving, centered around a big meal, she would be worried about being able to “make good choices” when it comes to food.

“You’re just really focused on the food as a whole rather than the holiday,” Rothenhoefer told ABC News’ Good Morning America, adding of the change she’s seen since starting the medication, “I’ve been able to turn that fear and anxiety into more enjoyment and making sure that you know, I’m still eating the foods that I enjoy. I’m just making sure that I’m not eating as much.”

Likewise, Joe Sapone, who has lost more than 100 pounds on Mounjaro, told GMA that for him, gathering at holidays like Thanksgiving is now more about the company he’s around than the food.

“My enjoyment has not really decreased,” he said. “Because it’s as much about being with family and friends as it is about eating food.”

Mounjaro and other drugs used for weight loss like Ozempic and Wegovy have skyrocketed in popularity over the past year as they have proven successful in changing some people’s eating habits and helping people who are overweight and obese lose weight.

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

The active ingredient in Mounjaro, tirzepatide, works by activating two naturally produced hormones in the body: glucagon-like peptide-1, known as GLP-1, and glucose-dependent insulinotropic polypeptide, or GIP. The combination is said to slow the emptying of the stomach, making people feel full longer, and suppress appetite by slowing hunger signals in the brain.

Mounjaro — made by Eli Lilly and Co. — is approved by the U.S. Food and Drug Administration to treat Type 2 diabetes. Earlier this month, the FDA approved the drug Zepbound to treat obesity, which contains the same active ingredient, tirzepatide, as Mounjaro.

The drug is similar to semaglutide, the active ingredient in the medications Ozempic and Wegovy — both made by Novo Nordisk — but works slightly differently because it targets two hormones involved in blood sugar control rather than just one.

Ozempic is currently approved by the FDA as a treatment for Type 2 diabetes alongside diet and exercise if other medications cannot control blood sugar levels well enough.

Wegovy is essentially the same injectable drug as Ozempic prescribed at a higher dosage. The FDA has specifically approved Wegovy for patients with severe obesity, or who are overweight and have one or more weight-associated conditions like high blood pressure or high cholesterol.

Possible side effects of all three medications — Mounjaro, Ozempic and Wegovy — include nausea and stomach pain.

Dr. Katherine Saunders, clinical assistant professor of medicine at Weill Cornell Medicine in New York City, said people who are taking medications used for weight loss should be prepared to manage their expectations when it comes to big holiday meals, like Thanksgiving.

“It doesn’t completely remove the pleasure that comes from food,” Saunders told GMA. “It enables people to have a couple of bites and then say, ‘I don’t need to eat a large portion of this. That was enough.'”

Saunders noted too that it can take time for people to adjust to eating different amounts and different varieties of foods when on medications like Ozempic and Mounjaro.

“It can definitely take some time for people to get used to eating differently and selecting food differently when they’re on these medications,” she said. “So, if you don’t change your eating behavior, or the content of your diet at all when you take these medications, that’s when people can get into trouble.”

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(NEW YORK) — More than two dozen premature, low-birthweight babies have been evacuated from Gaza to Egypt to receive specialized care amid the ongoing Israel-Hamas war.

But that is only the beginning of their precarious journey back to health as they escape the conflict zone.

A joint mission between the United Nations and the Palestine Red Crescent Society, led by the World Health Organization, evacuated 31 babies from the embattled Al-Shifa Hospital in northern Gaza to Al-Helal Al-Emarati Maternity Hospital in southern Gaza over the weekend. On Monday morning, 28 arrived in Egypt, while three others who were in stable condition continued to receive care in Gaza, WHO officials said.

In total, 39 babies were removed from incubators when Al-Shifa ran out of fuel on Nov. 11. Gaza has been under siege since the Oct. 7 terror attack by Hamas in Israel, and hospitals in Gaza have run out of fuel and been bombed.

As of Monday, at least five of the 39 babies have died, including three when the power to the incubators was cut off and two prior to evacuation, according to hospital staff and the WHO. The condition of three of the premature babies who remained at Al-Shifa because they didn’t need emergency care remains unclear.

Many of the surviving babies were suffering from life-threatening health conditions including dehydration, vomiting, hypothermia and sepsis because they didn’t receive any medication, and had not been in “suitable conditions for them to stay alive,” Mohamed Zaqout, director of Gaza hospitals, said in a statement Sunday. Hypothermia can be a problem for premature babies who cannot regulate their own body temperature and can be a sign of several types of infections. The risk of hypothermia and sepsis can increase when premature babies are removed too soon from incubators and don’t have adequate access to treatment.

This is the care doctors say they will need in order to survive.

Dr. Erin Schofield, a neonatologist at the University of Maryland Children’s Hospital and an assistant professor at the University of Maryland School of Medicine, told ABC News that premature infants are the most vulnerable group of people in any hospital.

“They’re the most technology-dependent, they are the most resource-dependent, and even in the United States, where we have every means to take care of them, they’re still the biggest utilizers of medical technology,” she said. “Premature babies are a lot more fragile than people think, and keeping them warm is not just an issue of holding them or bundling them in blankets.”

Premature infants need the final months and weeks in the womb to adequately develop their organs including the brain, lungs and liver, according to the Centers for Disease Control and Prevention. Doctors said premature infants have unique health needs and their lives can be at risk without the right specialized care.

When babies are born several weeks early, they often need medical equipment to “support really every organ system, and that at its basis, at its core requires electricity. It requires heat, and if they don’t have those, they [can] very quickly die,” Schofield said.

This care requires more than wrapping them up in a warm blanket.

“Premature babies often rely on intensive monitoring and interventions performed under constant clinical supervision given how fragile they are, particularly those born at earlier gestational ages,” Dr. Nicholas Cuneo, a hospitalist in the department of pediatrics at Johns Hopkins School of Medicine, told ABC News. “Without this type of intensive care, coupled with the appropriate resources, they can be at risk of serious and disabling complications or in some cases death.”

All suffering ‘serious infections’

Eleven or 12 of the evacuated babies are critically ill while the others are seriously ill, according to Dr. Rick Brennan, regional emergency director of the WHO Mediterranean region. Babies who are seriously ill typically require medical treatment and hospitalization but are not yet suffering life-threatening conditions, while those with critical illness are suffering from life-threatening conditions.

“Each of them has serious infections and quite a few of them have low body temperature, so they really do need detailed specialist care,” Brennan said Monday. “Overnight, they received antibiotics, supportive therapy, oxygen. We are hoping that this will help stabilize all of them.” Premature babies are at increased risk of getting infections, even in ideal conditions. Incubators that provide temperature regulation help stabilize babies in a number of ways, helping reduce the risk of infections among premature babies, while early removal can have cascading effects that increase the risk of infections, including sepsis, experts said.

“These tiny, delicate humans are sensitive and any lack of medications, consistent nutrition, temperature control, or even the slightest uncontrolled infection [could] be the difference between life or death,” Dr. Alok Patel, a pediatrician at Stanford Children’s Health and an ABC News medical contributor, said.

“Adequate care for these patients involves a multidisciplinary health care team including neonatologists, nurses, technicians, respiratory therapists, pharmacists, social workers and more,” Patel added.

A team of 10 neonatal specialists took custody of the 28 premature babies at the Rafah border crossing on Monday and moved them to hospitals in Al-Arish, the largest city on the Sinai Peninsula in Egypt, according to Brennan. One group of babies is being taken to hospitals in Cairo.

“They are all, again, seriously ill. They have a long road to go,” Brennan said. “It will take a long time for many of them to recover given their current condition, but we do understand that they are getting very good care at this time.”

WHO officials said the remaining three babies were in stable condition and didn’t need to be transferred from Gaza for further treatment in Egypt. It’s unclear if they were suffering from serious infections, as well.

‘They didn’t ask for this’

Even transporting the premature babies to a safer area can exacerbate some of the health conditions they are facing, Schofield said.

“Transport is not a benign event, and we don’t want to have to transfer a fragile premature baby unless we absolutely have to, unless the benefit outweighs the risk,” she said. “In this case, getting fragile premature babies out of the conflict zone, it certainly outweighs the risks.”

Schofield said once the babies are in a stable environment, staff will need to check for electrolyte imbalances from dehydration, signs of continued infection and internal bleeding.

They should be placed in incubators with temperature probes to control their body temperature, Schofield said. Additionally, they may require feeding tubes if they can’t eat by mouth yet, as well as regular feedings of breast milk or specifically made infant formula they may not have had access to for days.

“Premature babies … they didn’t ask for this,” Schofield said. “They didn’t ask to be born in a conflict zone, and I think we really owe it to them to do our best to give them the best chance at survival.

She added, “It’s heartbreaking to see these babies who, if they had not been born into conflict zones, really wouldn’t face many challenges, and now being born in a conflict zone adds just heaps and heaps upon them, all of these challenges that really no child should have to face, so as much as we can, limit that in their exposure to this.”

Dr. Jade A Cobern, M.D., M.P.H., is a pediatrician in a neonatal intensive care unit and a member of the ABC News Medical Unit.

ABC News’ Will Gretsky contributed to this report.

 

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(NEW YORK) — The Centers for Disease Control and Prevention (CDC) issued a warning Monday about a listeria outbreak linked to recalled peaches, nectarines and plums after 10 hospitalizations and one death were reported in seven states.

The agency said the affected fruits, which were distributed nationwide and sold at retail stores, were branded “HMC Farms” or “Signature Farms.” The recall did not include organic fruit.

HMC Group Marketing has voluntarily recalled the fruit, sold between May 1 and Nov. 15, 2022, and the same dates in 2023, that have a sticker reading “USA-E-U.” The stickers have numbers 4044 or 4038 for yellow peach, 4401 for white peach, 4036 or 4378 for yellow nectarine, 3035 for white nectarine, 4042 for red plum and 4040 for black plum. The recall is also for the fruit sold in two-pound bags. The CDC confirmed an investigation is ongoing to determine if any additional fruit or products made with this fruit may be contaminated.

Listeria infection is especially harmful to people who are pregnant, aged 65 or older, or with weakened immune systems due to its likeliness to spread beyond their gut to other parts of their body, according to the CDC.

The symptoms, including fever, muscle aches and tiredness for those who had caught the disease, may begin within two weeks after consuming the contaminated food. They may also occur as early as the same day or as late as 10 weeks after exposure, the CDC notes on its website.

Although the recalled fruits are no longer available in stores, they may still exist in the homes of consumers for later use, the CDC said in its release, adding that consumers should check their freezers and discard or return the fruits that meet the criteria. The agency also urged consumers to clean surfaces and containers that have touched the fruit.

In a statement to ABC News on Monday, Amy Philpott, a spokeswoman for HMC Group Marketing said, “There is nothing more important to us than providing safe, high-quality fruit to consumers.”

“We never want anyone to become ill from eating fresh fruit, and our hearts go out to those affected by the outbreak,” she added. “We are working tirelessly with the FDA to investigate how the contamination happened.”

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(NEW YORK) — Ahead of the approaching holidays and a potential rise in cases this winter, the government is once again allowing households to order a fresh wave of four COVID-19 tests for free online.

The website, covidtests.gov, remains one of the last remaining ways Americans can secure free at-home rapid test after the end of the public health emergency last spring ended the requirement for insurance companies to cover eight tests per month.

Over the past three years, the return of winter has also brought a resurgence of COVID-19. According to modeling data from the Centers for Disease Control and Prevention, health officials are anticipating a similar number of hospitalizations this year as they saw last year, which topped nearly 45,000 per week at its peak.

The test ordering site relaunched last month, offering four tests per household, and will now offer an additional four tests per household for anyone who has already ordered — or eight tests per household for anyone who hasn’t placed an order yet this fall.

Since September, about 14.5 million households have ordered tests, for a total of 58 million tests shipped, according to the Administration for Strategic Preparedness and Response, or ASPR, a department within the Department of Health and Human Services.

Health officials said they are hopeful people will take advantage of the free tests to better prepare for gathering with other people, particularly those who are more vulnerable to the coronavirus, during the holiday season.

“We’re going to see families gather with older loved ones and younger loved ones and it’s important that they are able to protect their loved ones from COVID as we head into the winter months,” said Dawn O’Connell, head of ASPR.

“So we think opening [COVIDTests.Gov] up right before the winter holidays really kick in is going to be very important for the American people, to provide this access for the free four tests again,” she said.

Some of the free tests that the government has stockpiled are also up against impending expiration dates, another reason to move the tests along, O’Connell said. The Food and Drug Administration recently extended expiration dates for many at-home tests, but they still have a relatively short shelf life.

“We know that the tests are going to be good for the next several months. They’re not going to be good forever. And so we think it’s important that we go ahead and have them in the hands of the American people so they can use them and protect themselves as we head into the winter,” O’Connell said.

The website for free at-home tests has had an on-and-off presence since the winter of 2022, when the omicron variant was driving cases up across the country.

At the time, President Joe Biden pledged to give out 1 billion free rapid tests to ease soaring demand and an overwhelmed test manufacturing industry.

But the government site was temporarily shut down that fall as a political fight dragged on over COVID-19 funding. Administration officials said they had to conserve tests in case they didn’t get agreement from Republicans to allocate more money — which they didn’t.

Conservatives have become more skeptical of continually providing billions to respond to the pandemic, including by pointing to fraud that marred some of the aid.

The testing site relaunched again in December 2022 as cases began to climb again, then shut down this past June, before relaunching in September of this year.

The tests will come from a $600 million investment in domestic test manufacturers, which will yield around 200 million tests and replenish the federal stockpile. Tests ordered from covidtests.gov will be pulled from that stockpile.

The funding for the $600 million investment will come from money that was left over from a past supplemental COVID-19 bill. Though the debt ceiling deal reached over the summer between Biden and Republicans in Congress did claw back about $30 billion in unspent relief funds, administration officials said there was still enough left over to put toward replenishing the testing stockpile this fall.

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(NEW YORK) — When a recent federal report published last week showed routine childhood vaccination rates had fallen among kindergartners for the 2022-23 school year, public health experts were disheartened to see the drop.

However, there was one state that lagged behind the rest: Idaho.

For all four major vaccines — measles, mumps and rubella (MMR); diphtheria, tetanus and acellular pertussis (DTaP); poliovirus (polio) and varicella (chickenpox) — Idaho had the lowest percentage of kindergartners who met school requirements for vaccinations, all around 81% compared to a nationwide rate of 93%.

What’s more, Idaho was the state with the highest percentage of exemptions from one or more required vaccines at 12.1%. Comparatively, the rate of exemptions across the U.S. was about 3%.

“This is concerning not only at a state level but nationally, as well, because we’re not the only state experiencing this; we just appear to be experiencing it a little more than other states,” Dr. Bethaney Fehrenkamp, a clinical assistant immunologist at Idaho WWAMI — a partnership between the University of Washington School of Medicine and Washington, Wyoming, Alaska, Montana and Idaho — told ABC News.

Public health experts noted that clusters of unvaccinated or under-vaccinated children can lead to outbreaks of preventable diseases such as measles, which is exceptionally contagious and can lead to serious complications such as pneumonia, encephalitis — which is inflammation of the brain — and even death, according to the Centers for Disease Control and Prevention.

In one case, between November 2022 and February 2023, a measles outbreak swept across several schools and day cares in central Ohio, infecting 85 children, 80 of whom were unvaccinated.

In Idaho, there was a measles outbreak last month that infected 10 people, according to the Idaho Department of Health & Welfare. Prior to that, there had been just two cases reported in Idaho in 20 years.

When you have an under-vaccinated population and a contagious disease, “it’ll spread and it’ll spread more easily,” Dr. Kevin Cleveland, an associate professor at the College of Pharmacy at Idaho State University, told ABC News.

The type of exemptions allowed also may pose a problem. All 50 states and Washington, D.C. allow exemptions for medical reasons while 45 states and D.C. grant exemptions on religious grounds, according to the National Conference of State Legislatures (NCSL).

However, there are also 15 states that grant philosophical exemptions due to “personal, moral or other beliefs,” the NCSL says. This means that parents can ask for an exemption for their child for just about any reason.

Experts say there are a few reasons why rates might be low. One is access. Idaho is a state with 35 of its 44 counties being rural and 174 physicians per 100,000 people, which may make it hard for people to reach providers or schedule appointments.

Additionally, the rates may be an after-effect of the COVID-19 pandemic. Some of the hesitancy around COVID-19 vaccines may have inadvertently spilled into concerns about other vaccines.

“We’ve seen a slow but kind of steady increase in vaccine hesitancy but that was exasperated by COVID-19,” Fehrenkamp said. “While some of the decreased vaccination rates during the pandemic itself were probably likely due to access and availability and maybe a fear of bringing your child to a health care facility during a pandemic — potentially, like misinformation and some lack of trust as well as incomplete transparency has also just kind of exasperated that trust, and made it worse.”

Cleveland said people may also be experiencing vaccine fatigue after being recommended by health experts to get COVID-19 boosters and updated vaccines to help combat circulating variants at various times.

“Every time we talk about a vaccine, it goes back to COVID vaccine,” he said. “I think people are just a little tired. It’s like, ‘Oh, no, another vaccine.'”

Another reason may be that because these diseases have been circulating at low rates due to vaccines, people have forgotten how serious they were before the advent of vaccines.

For example, in the decade before the MMR vaccine became available, it was estimated that 48,000 people were hospitalized with measles each year and between 400 and 500 people died each year, according to the CDC.

“These diseases are really, really contagious and they’re really serious and I think potentially, we’ve forgotten how serious these diseases can be and we require a certain number of the population to be vaccinated in order to get that protection for those that can’t be vaccinated,” Fehrenkamp said. “We’ve previously eradicated these diseases in the U.S., which is why I think maybe, culturally we have forgotten how serious and how detrimental they can be.”

To try to increase these numbers, Fehrenkamp said it’s important for health care providers to have honest conversations with parents about why they’re hesitant or concerned about vaccines to try to assuage their fears.

“I want parents to choose to vaccinate their children, but I want them to feel really good about it and I want them to feel really informed about it and so we need to do a better job informing on vaccine safety,” she said.

At Idaho WWAMI, Fehrenkamp said they bring in students from Idaho that have links to underserved communities to help educate them with the hope they’ll go back and practice in those areas and fill a health care gap.

Cleveland, who specializes in immunization outreach to underserved populations in Idaho, said it’s also important to bring those vaccines into rural or underserved communities to make it easier for people to keep up with vaccine schedules.

“Taking the vaccines to the people, especially in the rural areas or even like workplaces or schools, we usually have really good success in vaccine uptake,” he said.

 

Copyright © 2023, ABC Audio. All rights reserved.

(NEW YORK) — When a recent federal report published last week showed routine childhood vaccination rates had fallen among kindergartners for the 2022-23 school year, public health experts were disheartened to see the drop.

However, there was one state that lagged behind the rest: Idaho.

For all four major vaccines — measles, mumps and rubella (MMR); diphtheria, tetanus and acellular pertussis (DTaP); poliovirus (polio) and varicella (chickenpox) — Idaho had the lowest percentage of kindergartners who met school requirements for vaccinations, all around 81% compared to a nationwide rate of 93%.

What’s more, Idaho was the state with the highest percentage of exemptions from one or more required vaccines at 12.1%. Comparatively, the rate of exemptions across the U.S. was about 3%.

“This is concerning not only at a state level but nationally, as well, because we’re not the only state experiencing this; we just appear to be experiencing it a little more than other states,” Dr. Bethaney Fehrenkamp, a clinical assistant immunologist at Idaho WWAMI — a partnership between the University of Washington School of Medicine and Washington, Wyoming, Alaska, Montana and Idaho — told ABC News.

Public health experts noted that clusters of unvaccinated or under-vaccinated children can lead to outbreaks of preventable diseases such as measles, which is exceptionally contagious and can lead to serious complications such as pneumonia, encephalitis — which is inflammation of the brain — and even death, according to the Centers for Disease Control and Prevention.

In one case, between November 2022 and February 2023, a measles outbreak swept across several schools and day cares in central Ohio, infecting 85 children, 80 of whom were unvaccinated.

In Idaho, there was a measles outbreak last month that infected 10 people, according to the Idaho Department of Health & Welfare. Prior to that, there had been just two cases reported in Idaho in 20 years.

When you have an under-vaccinated population and a contagious disease, “it’ll spread and it’ll spread more easily,” Dr. Kevin Cleveland, an associate professor at the College of Pharmacy at Idaho State University, told ABC News.

The type of exemptions allowed also may pose a problem. All 50 states and Washington, D.C. allow exemptions for medical reasons while 45 states and D.C. grant exemptions on religious grounds, according to the National Conference of State Legislatures (NCSL).

However, there are also 15 states that grant philosophical exemptions due to “personal, moral or other beliefs,” the NCSL says. This means that parents can ask for an exemption for their child for just about any reason.

Experts say there are a few reasons why rates might be low. One is access. Idaho is a state with 35 of its 44 counties being rural and 174 physicians per 100,000 people, which may make it hard for people to reach providers or schedule appointments.

Additionally, the rates may be an after-effect of the COVID-19 pandemic. Some of the hesitancy around COVID-19 vaccines may have inadvertently spilled into concerns about other vaccines.

“We’ve seen a slow but kind of steady increase in vaccine hesitancy but that was exasperated by COVID-19,” Fehrenkamp said. “While some of the decreased vaccination rates during the pandemic itself were probably likely due to access and availability and maybe a fear of bringing your child to a health care facility during a pandemic — potentially, like misinformation and some lack of trust as well as incomplete transparency has also just kind of exasperated that trust, and made it worse.”

Cleveland said people may also be experiencing vaccine fatigue after being recommended by health experts to get COVID-19 boosters and updated vaccines to help combat circulating variants at various times.

“Every time we talk about a vaccine, it goes back to COVID vaccine,” he said. “I think people are just a little tired. It’s like, ‘Oh, no, another vaccine.'”

Another reason may be that because these diseases have been circulating at low rates due to vaccines, people have forgotten how serious they were before the advent of vaccines.

For example, in the decade before the MMR vaccine became available, it was estimated that 48,000 people were hospitalized with measles each year and between 400 and 500 people died each year, according to the CDC.

“These diseases are really, really contagious and they’re really serious and I think potentially, we’ve forgotten how serious these diseases can be and we require a certain number of the population to be vaccinated in order to get that protection for those that can’t be vaccinated,” Fehrenkamp said. “We’ve previously eradicated these diseases in the U.S., which is why I think maybe, culturally we have forgotten how serious and how detrimental they can be.”

To try to increase these numbers, Fehrenkamp said it’s important for health care providers to have honest conversations with parents about why they’re hesitant or concerned about vaccines to try to assuage their fears.

“I want parents to choose to vaccinate their children, but I want them to feel really good about it and I want them to feel really informed about it and so we need to do a better job informing on vaccine safety,” she said.

At Idaho WWAMI, Fehrenkamp said they bring in students from Idaho that have links to underserved communities to help educate them with the hope they’ll go back and practice in those areas and fill a health care gap.

Cleveland, who specializes in immunization outreach to underserved populations in Idaho, said it’s also important to bring those vaccines into rural or underserved communities to make it easier for people to keep up with vaccine schedules.

“Taking the vaccines to the people, especially in the rural areas or even like workplaces or schools, we usually have really good success in vaccine uptake,” he said.

Copyright © 2023, ABC Audio. All rights reserved.

(NEW YORK) — There have been dozens of eye drops pulled off shelves in the past year due to bacterial and fungal contamination, with multiple warnings issued by the Food and Drug Administration.

Experts and advocates say one reason is likely that in-person faculty inspections slowed significantly during the pandemic, meaning there’s been less regulatory oversight. Now, however, federal regulators may be cracking down after some consumers reported serious health effects.

The latest warning alone included over two dozen eye drops from big name retailers such as CVS Health, Rite Aid, and Target.

FDA action on eye drop products seemingly started to ramp up following an initial warning by the agency back in February that warned of at least one death linked to products contaminated with bacteria.

The agency has also regained the ability to conduct more in-person inspections of manufacturing facilities, following a lull during the pandemic. In fact, the FDA was unable to complete more than 1,000 of its planned fiscal year 2020 inspections, according to the Government Accountability Office.

In the most recent case, the FDA found “insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility,” according to the warning issued by the agency.

These inspections occur periodically to ensure the quality and safety of products – akin to a surprise food inspector at a restaurant.

“FDA has an algorithm that they use…kind of a risk-based model where they pick and choose the facilities that they inspect based on kind of the level of risk,” Erin Fox, the associate chief pharmacy officer at University of Utah Health, told ABC News.

“In general, it should happen like every three years on average, but some are inspected more frequently than others,” Fox added.

While the FDA is charged with regulating over the counter products, it has limited legal authority to issue a mandatory recall, often times leaving the decision whether or not eye drops are pulled from shelves to the manufacturers or retailers.

“The FDA can’t, in general, force any company to recall a product or a drug product, whether it’s OTC or prescription. That’s why, like, a lot of times when you see a recall, notice, you’ll see it’s a voluntary recall,” Fox said.

In fact, the federal agency can only issue mandatory recalls for a few kinds of products including infant formula, medical devices, food, tobacco products, electronic products, controlled substances, biological products and, more recently, cosmetics, according to an FDA spokesperson.

There are also instances where mandatory recalls can be issued for false marketing of product efficacy, according to Teresa Murray, a consumer watchdog with U.S. Public Interest Research Group.

“So conceivably, the manufacture could sell like a daily vitamin that contains some kind of bacteria and the FDA would not be able to do a mandatory recall. But if the label says that the vitamin will help you live 1000 years, then the FDA could do a recall for false marketing,” Murray said.

If a manufacturer or retailer won’t comply with a mandatory recall, some of the only recourse regulators like the FDA have at their disposal are civil penalties.

“There’s a process where they can go ahead and file a civil action, take a company to court and say, okay, you’re not going to comply, doggone it, we’re going to take you to court. But then, of course, that’s a long protracted process, and it costs, frankly, money and resources that these regulators don’t have,” Murray said.

Along with the lack of authority to issue mandatory recalls, voluntary recalls can sometimes take an extensive period of time to be issued.

“A lot of times, the regulator and the company, and all of their team of lawyers will negotiate the wording of the recall. And that can take days or weeks,” Murray said.

In the meantime, the FDA can put out a warning, as the many that have been issued for contaminated eye drops.

Multiple bills have been introduced in Congress to broaden the FDA’s ability to issue mandatory recalls for prescription and over the counter medicines, such as the Protecting Americans from Unsafe Drugs Act, yet none have made it into law.

Eye drops that have been listed as contaminated should not be purchased or used and should be disposed of, according to the FDA.

“If anyone using these drops has eye discharge, redness or pain (i.e. signs of infection) they should see an ophthalmologist immediately,” said Dr. Christopher Starr, an associate professor of ophthalmology at Weill Cornell Medicine and spokesperson for the American Academy of Ophthalmology told ABC News.

Eye drops can also expire, where they pose a higher risk of contamination.

“I remind everyone to also check expiration dates of their eye drop bottles. If expired, please discard them, as there is a higher risk of contamination even with non-recalled, well-manufactured eye drops,” Starr added.

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(NEW YORK) — Global cases of measles increased by 18% from 2021 to 2022, following a drop in vaccinations over the past few years, according to a new report Thursday from the World Health Organization and Centers for Disease Control and Prevention.

Deaths due to measles have also increased globally by 43% from 2021 to 2022, the new data shows.

“The alarming increase in measles cases and deaths globally is a clear warning sign,” said Dr. John Brownstein, an ABC News medical contributor and chief innovation officer at Boston Children’s Hospital. “The drop in vaccination rates over recent years has set the stage for this resurgence, particularly impacting children who are most vulnerable.”

So far this year in the United States, 41 measles cases have been reported by more than a dozen states. Domestic cases of measles surged in 2019, with an estimated 1,274 people sick in at least 31 states — the greatest number of cases reported since 1992.

“The recent outbreaks of measles in the U.S. are a stark reminder of the consequences of vaccine hesitancy, emphasizing the need for robust public health campaigns to bolster confidence in and uptake of the MMR [measles, mumps and rubella] vaccine,” Brownstein said.

Most of the cases were among young people who were not vaccinated, and most outbreaks occur in groups of people who are not up to date on their vaccines.

An estimated 92% of American adolescents aged 13-17 were vaccinated against measles in 2019, according to the CDC. The federal agency notes that a vaccination coverage rate of 95% with both doses is necessary to protect communities from outbreaks.

Childhood immunizations overall — including the measles, diphtheria, tetanus and pertussis (DTaP), polio and chickenpox vaccines — have dipped in recent years among kindergarteners, decreasing from 95% in 2019 to 94% in 2020, then to 93% in 2021, according to the CDC.

The MMR vaccine is about 93% effective against measles, increasing to 97% after the second dose, according to the CDC.

Children in the U.S. need two doses of the MMR vaccine for best protection. The first dose is given between 12-15 months of age followed by a second dose between 4 to 6 years of age.

According to the latest global report from health officials, a total of 37 countries experienced large outbreaks in 2022 compared to 22 countries in 2021.

The majority of the countries with outbreaks were located in Africa, as well as a handful in the Eastern Mediterranean region.

“The rise in measles [is] a reflection of a growing health crisis that disproportionately affects children, especially in low-income countries. It’s crucial to close the immunization gap and guarantee every child access to essential vaccines,” Brownstein said.

There were an estimated 9 million cases of measles and 136,000 deaths globally, mostly among children, according to the report.

There were 33 million children who missed a measles vaccine dose in 2022, including about 11 million getting their first shot but missing their second dose, the health agencies said.

Measles can cause serious health complications, especially in children younger than 5, according to the CDC. About one in five people in the U.S. who get measles will be hospitalized.

 

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(NEW YORK) — The United States continues to be one of the “most dangerous developed nations” for childbirth, according to a new report released Thursday by March of Dimes, a nonprofit organization focused on improving the health of pregnant people and babies.

The U.S. earned a D+ grade on its preterm birth rate for the second straight year in March of Dimes’ annual report looking at the state of maternal and infant health.

The preterm birth rate was 10.4%. The report also notes that the U.S. saw a 3% increase in infant mortality over the past year and a maternal death rate that doubled from 2018 to 2021.

When it comes to preterm births, one of the leading causes of infant deaths in the U.S., more than 380,000 babies were born before 37 weeks over the past year, according to March of Dimes. There are also large racial disparities when it comes to preterm births, according to the report, with Black and American Indian/Alaskan Native women 54% more likely to have a preterm birth compared to white women.

Racial disparities also exist when it comes to maternal health, with non-Hispanic Black women dying due to pregnancy-related complications at a rate 2.6 times that of non-Hispanic white women, according to data from the U.S. Centers for Disease Control and Prevention.

In addition, a separate March of Dimes report released earlier this year found that more than 5.6 million women in the U.S. live in counties with limited or no access to maternity care services. Since 2018, there has been a 4% increase in maternity care deserts, defined by March of Dimes as “any county in the United States without a hospital or birth center offering obstetric care and without any obstetric providers.”

“This year’s report shows the state of infant and maternal health in the United States remains at crisis-level, with grave disparities that continue to widen the health equity gap,” Dr. Elizabeth Cherot, president and CEO of March of Dimes, said in a statement about Thursday’s report. “We have long known that many of the factors impacting poor outcomes for moms and babies can and must be addressed if we are to reverse these trends.”

She continued, “The fact is, we are not prioritizing the health of moms and babies in this country, and our systems, policies, and environments, as they stand today, continue to put families at great risk.”

States where infant, maternal outcomes are the worst

The South and Midwest regions of the U.S. continue to have the worst outcomes when it comes to infant and maternal health, according to the March of Dimes report.

Louisiana, Arkansas, South Carolina, Oklahoma, Ohio, Mississippi and Alabama are among the states with the highest infant mortality rate. Those states each had an infant mortality rate of at least 7 deaths per 1,000 live births, compared to the national average of 5.4 deaths per 1,000 live births.

Infant mortality is defined by the CDC as “the death of an infant before his or her first birthday.”

The primary causes of infant mortality include birth defects, preterm birth and low birth weight, sudden infant death syndrome, accidents and injuries, and maternal pregnancy complications, according to both the CDC and March of Dimes.

States including Oklahoma, Alabama, Arkansas, Louisiana, Texas and Mississippi also had the worst maternal health outcomes, according to the March of Dimes report.

Among all states, birthing people living in Louisiana are the most vulnerable to “poor maternal health outcomes,” according to the report, with 39 deaths per 100,000 live births.

The report did not go into specific causes for poor maternal health, but cited “clinical risk factors and other social, contextual, and environmental factors.”

Previous research has shown that birthing women, and people of color specifically, often face discrimination or other gaps in care when receiving health care, and that is linked to poorer treatment.

Lack of proper health care and existing health complications — like diabetes, obesity and hypertension — are among the factors that can make pregnant women more likely to have a preterm birth, according to the March of Dimes.

The report found, again, that states in the South — including Alabama, Georgia, South Carolina, Mississippi, Arkansas and Louisiana — had the highest rates of preterm birth.

To improve the state of maternal and infant health care in the U.S., the March of Dimes, in its report, called for several policy changes, including extending Medicaid health care benefits to one year after the birth of a child, the expansion of mandatory paid parental leave, Medicaid coverage of doula care for birthing women and federally funded maternal mortality and fetal and infant mortality review committees in every state.

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(NEW YORK) — A proposed amendment in Florida that would enshrine abortion rights in the state’s constitution is currently at the center of a battle that could be taken up by the state’s Supreme Court.

State Attorney General Ashley Moody and other groups have asked Florida’s highest court to prevent the Amendment to Limit Government Interference with Abortion from being put on the ballot for a vote in the 2024 election.

The proposed amendment reads, in part, “No law shall prohibit, penalize, delay, or restrict abortion before viability or when necessary to protect the patient’s health, as determined by the patient’s healthcare provider.”

Floridians Protecting Freedom, the initiative’s main sponsor, and the ACLU of Florida filed response briefs to the attorney general’s challenge, arguing that the ballot initiative’s language is clear and does not mislead voters, as opponents have claimed.

The effort to include the initiative on the Florida ballot comes on the heels of Ohio voters approving a constitutional amendment during last week’s election that guarantees access to abortion and other aspects of reproductive health care.

Currently, abortion is banned at 15 weeks or later in Florida, according to the Guttmacher Institute, a research group that studies sexual and reproductive rights.

Patients seeking abortion are required to make two trips: the first for an in-person appointment, and the second 24 hours later for the abortion itself.

Additionally, only physicians are allowed to perform abortions and not other qualified health care professionals, the Guttmacher Institute says.

As of Monday, Floridians Protecting Freedom has collected more than 491,000 signatures of the 891,523 required to place the Amendment to Limit Government Interference with Abortion on the ballot. However, the number of signatures collected is already enough to qualify it for ballot summary review by the Florida Supreme Court.

If the amendment makes it onto the ballot and is subsequently passed by a majority of voters, it would protect abortion up until the fetus can survive outside the womb, which is generally considered to be between 24 and 26 weeks’ gestation. It would also make Florida the eighth state to protect abortion rights or prevent further restricting those rights, via a ballot imitative, since the Supreme Court voted to overturn Roe v. Wade in June 2022

There is no language in the proposed Florida amendment addressing what type of health care professional is or is not allowed to perform an abortion, or whether there is a mandatory 24-hour wait period between requesting an abortion and receiving one, as the law currently requires.

If the amendment doesn’t make it on the ballot, or if it does but isn’t passed by a majority of voters, that failure could help clear the way for a six-week abortion ban to be enacted.

In April 2023, Florida Gov. Ron DeSantis signed a six-week abortion ban into law, replacing the previous 15-week ban. The legislation makes exceptions for when a woman’s life or health is at risk and for cases of rape or incest, under certain conditions.

Two physicians currently must certify in writing that an abortion is necessary to save the woman’s life or to avert a serious risk of substantial and irreversible physical impairment of a major bodily function of the pregnant woman. If two physicians are not available, one physician must certify in writing the above, as well as that a second physician is not available to consult.

For abortions in the case of rape or incest, the exceptions allow the procedure to be performed up to 15 weeks into the pregnancy, and if the woman provides a copy of a restraining order, police report, medical record or other court order or documentation proving that she’s a victim of rape or incest.

Currently, the 15-week ban is on hold while the Florida Supreme Court decides whether it’s constitutional, following challenges by the Center for Reproductive Rights and other groups. If the 15-week ban is upheld, then the six week-ban will be allowed to go into effect.

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