EPA proposes first-ever limit on ‘forever chemicals’ in drinking water

EPA proposes first-ever limit on ‘forever chemicals’ in drinking water
EPA proposes first-ever limit on ‘forever chemicals’ in drinking water
Tim Graham/Getty Images

(WILMINGTON, N.C.) — The Environmental Protection Agency proposed its first-ever rule to reduce the prevalence of PFAS chemicals in drinking water Tuesday, taking the first step to require cities to test for the so-called “forever chemicals.”

“Today, I am thrilled to announce that EPA is taking yet another bold step to protect public health. I’m so proud to announce that EPA is proposing the first ever national standard to protect communities from PFAS in drinking water. This is something that communities like Wilmington have been demanding for years. And today we’re finally answering those calls,” EPA Administrator Michael Regan said at the announcement in Wilmington, North Carolina.

The type of chemicals known as PFAS, short for per- and poly-fluorolalkyl substances, have become ubiquitous in modern life, used in everything from household products like nonstick pans, waterproof clothing and furniture to industrial uses like military-grade firefighting foam and manufacturing. They’re often nicknamed “forever chemicals” because they can stay in the environment or in the human body for a long time once they’re introduced.

The proposed EPA rule will regulate two of the oldest these chemicals — PFOA and PFOS — as well as a mixture of four other chemicals in this category including GenX, which has been detected in the Cape Fear River in North Carolina.

“It’s the resilient and durable qualities that make these chemicals so useful in everyday life. But it’s also what makes them particularly harmful to people in the environment,” Regan said Tuesday. “What began as a so-called miracle groundbreaking technology meant for practicality and convenience, quickly devolved into one of the most pressing environmental and public health concerns in the modern world.”

Long-term exposure to certain types of PFAS, which can accumulate in the body over time, “have been linked to serious illnesses, including cancer, liver damage and high cholesterol,” according to Regan.

PFOA and PFOS will be limited at a maximum level of four parts per trillion, meaning any water system that identifies levels above that would need to notify residents and take actions to get levels at least down to at least that level. The EPA previously recommended that anything above 70 parts per trillion is considered unsafe, but it lowered that health advisory level last year.

There hasn’t been national testing to determine how many Americans have this level of the chemicals in their water, but the EPA estimates that 3,400-6,300 water systems serving 70-94 million people use water that contains PFAS levels above what will be allowed under this rule.

The agency says the rule will prevent thousands of deaths and reduce tens of thousands of illnesses attributable to PFAS if fully implemented.

The American Chemistry Council, a trade group that represents the industry that makes these chemicals, says it supports drinking water limits on PFOS and PFOA but disagrees with the science EPA used to decide on the maximum limits.

“PFOA and PFOS were phased out of production by our members more than eight years ago. We support restrictions on their use globally, and we support drinking water standards for PFOA and PFOS based on the best available science,” ACC said in a statement. “However, we have serious concerns with the underlying science used to develop these proposed MCLs and have previously challenged the EPA based on the process used to develop that science.”

Many advocates and experts applauded EPA’s rule as a critically important step but said they still want to see the agency regulate all 12,000 chemicals in the PFAS category and hold the companies who make the chemicals and caused PFAS pollution accountable.

“EPA’s groundbreaking proposal to regulate six PFAS ‘forever chemicals’ for the first time is crucially important. We have a five-alarm fire. Setting strong standards will help ensure the fundamental right of every family to have safe water flowing from their kitchen tap. We must crack down on PFAS polluters. They should be required to halt further pollution, clean up the contamination they’ve already caused, and pay to treat PFAS-contaminated drinking water,” Erik Olson, senior strategic director for health at the Natural Resources Defense Council, said in a statement.

Regan said the Biden administration has also made $9 billion available as a “shot in the harm” to help public water systems start to address this issue.

The EPA rule will be published for public comment and could be revised. Regan said he plans to finalize it by the end of this year.

Copyright © 2023, ABC Audio. All rights reserved.

102-year-old fitness instructor shares her advice to get active

102-year-old fitness instructor shares her advice to get active
102-year-old fitness instructor shares her advice to get active
Courtesy of Sean Tran of Elk Ridge Village Senior Living

(NEW YORK) — At 102 years old, Jean Bailey is not slowing down.

Bailey, an independent living resident at Elk Ridge Village, a senior living community in Omaha, Nebraska, has been leading fitness sessions for her neighbors since the COVID-19 pandemic first started in 2020.

“We couldn’t get out and so we just get out on our floor and started and it just got to be a habit,” Bailey explained in an interview with ABC News’ Good Morning America, adding that she’s been fitness instructing for at least 15 years now.

Approximately 10 to 12 residents regularly attend Bailey’s class, which is held four times a week and involves various movements like circular foot stretches and arm swimming stretches. Although Bailey, a former 4-H leader, herself said she’s “kind of strict” about the moves, she encourages everyone to get started at their own pace and “just move.”

“You don’t have to start out doing this as very strict. But, and we have a couple that — one girl has had a stroke and and there’s one who has arthritis — and I just tell them to, I don’t care what they do but move,” Bailey said.

Bailey said she doesn’t have a favorite move but emphasizes a holistic approach to moving the whole body.

“You just start with your chin on your chest and then you end up making circles with your head and you go to your arms and you go to your legs, you go to your back,” Bailey explained. “They’re all really good, especially the moving parts of your knees and hips and that kind of thing. It’s pretty important to keep those moving fully if you keep walking.”

Aside from staying active, Bailey, who previously owned a floral business, said she’s also keen on keeping up with the community at Elk Ridge Village and enjoys playing card games and dealing blackjack specifically.

Sean Tran, an operations director at Elk Ridge Village, has known Bailey ever since she moved in 14 years ago and said she is “very welcoming to everyone” and maintains a “very positive outlook.”

“She pretty much participates in almost every activity that we’ve got here. So everybody knows who she is and you can’t help but want to hang out and spend some time with her. She’s the sweetest,” Tran said.

As for the secret to her longevity, Bailey said she doesn’t think there’s been any steadfast formula.

“There isn’t any secret. I bet probably genes has something to do with it, the fact that I’ve always been busy,” Bailey said. “I always have a saying for the girls before we start exercising and today was, ‘The only way you can multiply happiness is to divide it.’”

Copyright © 2023, ABC Audio. All rights reserved.

Study: Sudden unexplained infant death rates show steep rise among Black babies in 2020

Study: Sudden unexplained infant death rates show steep rise among Black babies in 2020
Study: Sudden unexplained infant death rates show steep rise among Black babies in 2020
Stephanie Nantel/Getty Images

(NEW YORK) — A new study has found that, amid record low infant mortality rates in 2020, rates of sudden infant death syndrome, known as SIDS, increased for the first time in five years, and there was a sharp increase in the rate of sudden unexpected infant deaths, or SUID, among Black infants between 2019 and 2020.

The study, published by the American Academy of Pediatrics with research from the Centers for Disease Control and Prevention, found that the SUID rate per 100,000 live births was highest among Black infants in 2020, surpassing the SUID rate among non-Hispanic American Indian or Alaskan Native infants, which had been declining since 2015.

Black babies recorded 214 deaths per 100,000 while American Indian or Alaskan Native infants recorded 205.1 deaths per 100,000, nearly three times the rate of non-Hispanic white infants, which were recorded at 75.6 deaths per 100,000, according to the research.

The lowest SUID rates were observed among Hispanic and Non-Hispanic Asian infants with 59 deaths per 100,000 and 23.3 deaths per 100,000.

“There’s been a long-standing disparity in sudden unexpected infant death with non-Hispanic Black Americans having more than twice the rate of the general population, and then an even higher increase in the rate compared to non-Hispanic white (babies),” Rebecca Carlin, M.D., who co-authored the commentary released with the study, told ABC News. “In a lot of ways, the pandemic only increased a lot of the causes of that disparity.”

When asked if the results of the study were surprising, Carlin told ABC News that she doesn’t think so.

“I think that these authorities have been so long-standing and they’ve been so difficult to address that any event that increases disparities generally, it’s not surprising that it would also increase disparities in SUID deaths,” she added.

“Sudden unexplained infant deaths” includes deaths categorized as “sudden infant death syndrome,” “accidental suffocation and strangulation in bed,” and “unknown cause.”

“Sudden infant death syndrome” is a term coined to define sudden and unexpected deaths of infants less than 1 year old due to an unknown cause, or a cause not obvious before their death, as defined by the CDC.

This study included SUID rates and its sub-categorizations, including SIDS.

In the commentary released with the study, the authors discuss that the results of the study highlighting the SUID disparities between races reflected a current societal phenomenon.

“This rise further increases the already existing disparities in these deaths, with the rate among infants born to non-Hispanic Black families now 2.3-fold higher than the general population and 2.8-fold higher than infants born to non-Hispanic white families,” the study’s commentary authors wrote.

Researchers found the disparities while studying the increase in SIDS from 2015-2020. After four years of a steady decline in SIDS from 2015 to 2019, they saw a 15% rise during the first pandemic year, from 33.3 deaths per 100,000 in 2019 to 38.2 per 100,000 in 2020.

While there is no known cause for the spikes in SUID and SIDS cases from 2019-2020 for non-Hispanic Black infants, the commentary speculated on factors that may have contributed to the increase.

“These disparities are likely multifactorial, reflecting poverty levels, lack of access to prenatal and well-child care, and education regarding safe sleep and other practices, including the feeding of human milk, which can reduce the risk of SUID, and social norms related to these practices that vary between communities,” the commentary read.

Carrie Shapiro-Mendoza, Ph.D., one of the researchers of the study, agreed with those disparities and voiced what she thinks are contributing factors to the spike in a statement sent to ABC News.

“We know that the COVID-19 pandemic and related mitigation efforts (e.g., stay-at-home orders) disproportionately affected racial and ethnic minority communities compared to non-Hispanic white communities. It may have led to more unsafe sleep practices like bedsharing, thereby increasing the occurrence of SIDS and other sudden unexpected infant deaths,” said Shapiro-Mendoza, who holds a master’s degree in public health.

“More research is needed to address persistent racial or ethnic disparities in SUID,” she added. “By better understanding the factors that influence the trends in these rates and finding new approaches to encourage safe sleep practices, we can help reduce future infant deaths.”

Copyright © 2023, ABC Audio. All rights reserved.

Here’s what the FDA and CDC wrote in a letter to Florida’s surgeon general about his COVID vaccine claims

Here’s what the FDA and CDC wrote in a letter to Florida’s surgeon general about his COVID vaccine claims
Here’s what the FDA and CDC wrote in a letter to Florida’s surgeon general about his COVID vaccine claims
Sarah Silbiger/Getty Images

(WASHINGTON) — The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention recently sent a letter to Florida’s surgeon general debunking his claims about COVID-19 vaccines.

Last month, Dr. Joseph Ladapo had written his own letter to the federal health agencies, saying he was concerned about adverse effects from mRNA COVID-19 vaccines. He claimed there had been an increase in reports made to the CDC’s database, the Vaccine Adverse Event Reporting System (VAERS).

In the system, anyone — be it a healthcare professional or the average citizen — can report an event they think might have been related to a vaccine they received. It serves as an early warning system for federal health officials to sift through the unverified reports to confirm if an investigation or further action is necessary.

In response, FDA Commissioner Robert Califf and CDC Director Rochelle Walensky said their agencies are constantly monitoring data to see if there are any potential risks — but added that Ladapo focusing on a rare, minor events can cause misinformation to spread and can undermine public health efforts.

“It is the job of public health officials around the country to protect the lives of the populations they serve, particularly the vulnerable,” the FDA and CDC wrote in their letter. “Fueling vaccine hesitancy undermines this effort.”

Here is what’s in the letter and why an expert says it can be dangerous to fuel vaccine hesitancy:

“The claim that the increase of VAERS reports of life-threatening conditions reported from Florida and elsewhere represents an increase of risk caused by the COVID-19 vaccines is incorrect, misleading and could be harmful to the American public,” the letter states. “Reports of adverse events to VAERS following vaccination do not mean that a vaccine caused the event.”

Dr. William Schaffner, a professor of preventive medicine at Vanderbilt University Medical Center, told ABC News the insistence that a report made to VAERS means the vaccines are not safe is a perfect example of correlation without causation.

“The reporting system is the beginning of a series of investigations that then try to assess whether there might be a causal relationship as opposed to a coincidental relationship,” he said. “And that’s one of the most misunderstood aspects. Just because there’s a report in VAERS does not mean that the vaccine caused the event that’s reported.”

Schaffner explained someone may have a medical event after receiving the vaccine, but that doesn’t mean it was triggered by the vaccine at all, rather it just happened to follow. He likened it to a rooster crowing before the sun rises.

“We all know that the rooster crows before the dawn, but we don’t think that the rooster made the sun come up,” he said. “So that was coincidence. How do we distinguish coincidence from causality? Because we know if we silence the rooster, the sun will come up anyway.”

Schaffner said that the fact VAERS exist, and people can make those reports is evidence that federal officials are being transparent, not that there is anything to hide.

He added that people can tune into meetings of the CDC’s Advisory Committee on Immunization Practice to hear the data “presented very carefully, with the proviso that we’re going to present the various data and then show you how we have further analyzed the data and done further investigations to address various issues of vaccine safety.”

In October 2022, Ladapo recommended against men between ages 18 and 30 receiving the COVID-19 mRNA vaccines due to a “modestly increased” risk of cardiac-related deaths in an analysis posted online. The study was widely criticized by the medical and scientific community due to its poor methodology and never having to go through the rigorous standards of peer-review.

The agencies wrote in their letter that cardiovascular experts found the risk of strokes and heart attacks was lower in people who were vaccinated against COVID-19, not higher.

Last year, Ladapo also formally recommended against COVID-19 vaccinations for healthy children.

However, multiple peer-reviewed studies, listed in the letter, show that the risk of death, serious illness and hospitalization is higher for unvaccinated people in all age groups.

According to the agencies’ most recent estimates, also shared in the letter, those with the updated, bivalent booster had a 9.8-fold lower risk of dying from COVID-19 than unvaccinated people.

Additionally, they were estimated to be 2.4 times less likely to die from COVID-19 than those who are vaccinated but have not received the updated shot.

“COVID continues to be one of the 10 leading causes of death,” Schaffner said. “We can keep two thoughts in our mind at the same time. Yes, it is true that children are less seriously affected than, for example, senior citizens.”

He continued, “However, although they are less affected, it doesn’t mean they’re unaffected. Indeed, they are infected severely enough.”

Schaffner advised parents who are concerned to directly speak to their children’s pediatricians about the COVID-19 vaccines.

“Speak to the physician in whom you do have confidence and trust the person who has been there for you and your children in the past and is there for them now, and will be in the future,” he said.

In a statement to ABC News, the Florida Department of Health blasted back against the federal agencies and claimed the letter is not truthful.

“The response from the federal government is just another redundant display of the same apathetic talking point of ‘safe and effective,'” a spokesperson said in a statement. “Googling their fact sheets would have achieved the same result. While the Feds gaslight the American public, Florida pushes for the truth.”

The statement continued, “Three inquiries remain unanswered: 1. Access to raw patient-level data to allow for unbiased research. 2. Adequate attention surrounding the risks detected by numerous researchers around the world. 3. Public transparency from the CDC, FDA, and Big Pharma.”

Copyright © 2023, ABC Audio. All rights reserved.

The winter COVID wave that wasn’t: Why the US didn’t see a surge

The winter COVID wave that wasn’t: Why the US didn’t see a surge
The winter COVID wave that wasn’t: Why the US didn’t see a surge
SONGPHOL THESAKIT/Getty Images

(NEW YORK) — When the United States saw COVID-19 cases and deaths rise around this past Christmas and New Year’s, many Americans feared the country was in for a third winter wave.

But as quickly as both metrics went up, they also came down. Weekly cases and deaths in late winter 2022-23 are on par with what was seen in spring 2022, according to data from the Centers for Disease Control and Prevention.

Last year, the Biden administration issued a bleak warning that as many as 100 million Americans could be infected during a COVID-19 wave in the fall and winter.

However, as the third anniversary of the World Health Organization declaring the virus to be a global pandemic passes, it appears that the U.S. has survived its first winter without a massive COVID-19 surge.

Experts told ABC News that a combination of more immunity, better treatments, less severe infections and more people following mitigation measures likely played a role.

“We did not see a wave because we had a very high immunity due to infections and vaccinations,” Dr. Ali Mokdad, an epidemiologist with the University of Washington’s Institute for Health Metrics and Evaluation in Seattle, told ABC News. “Omicron and its subvariants did not spare anyone. Also, many of the infections were minor and not reported or did not end in a hospitalization.”

Comparison between winters

During the first winter wave, weekly cases peaked at 1,714,256 the week of Jan. 13, 2021, as did weekly deaths at 23,378, according to CDC data.

Subsequently, during the second winter wave — due to the omicron variant — weekly infections reached their high point of 5,630,736 the week of Jan. 19, 2022, and weekly deaths saw a high of 17,373 the week of Feb. 2, 2022, the data shows.

By comparison, according to the CDC, the highest number of weekly cases seen during the most recent winter wave was 472,601 the week of Dec. 7, 2023 — the first time the peak has not surpassed 1 million.

Meanwhile, weekly deaths peaked at 4,448 the week of Jan. 11, 2023 — five times lower than the peak during the first winter wave and nearly four times lower than the peak during the second wave.

Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hospital and an ABC News contributor, said there is some inconsistency when comparing past winter surges to this winter because there was a lack of overall testing and a declined use of home tests this winter.

However, the lower number of hospitalizations and deaths is likely a good indication of a less severe season this year compared to previous years, he said.

“Even though infections this winter were high in the community, the hospitalizations were relatively stable compared to the past few years,” Dr. Peter Chin-Hong, an infectious diseases specialist at the University of California, San Francisco, told ABC News. “Many of us suspected that it wouldn’t last very long.”

More immunity

Experts told ABC News that as winters have gone by, more immunity has built up in the population.

During the first winter wave, COVID-19 vaccines were not widely available. They only began being rolled out in mid-December and only for specific groups, including health care workers and adults aged 65 and older.

By the time the second winter wave rolled around, most of the U.S. population had gotten a primary series, according to CDC data, and the first booster was available to the general population.

During this most recent winter, an updated bivalent booster is also available, which — although only 16.2% of the population has received it — has likely offered at least some protection.

“I think the reduction in serious diseases is increased population immunity,” Chin-Hong said. “Just the percentage of people who have been exposed and then you layer on that vaccinations.”

Last year, the CDC estimated that, as of May 2022, more than 94% of the U.S. population has COVID-19-induced antibodies either from past infection or vaccination.

Evolution of treatments

The experts said another reason this season may not have been as severe for COVID is that we have more effective treatments.

During the first winter wave, remdesivir was the only drug approved to treat patients with severe COVID cases.

However, clinical trial data was later released showing the drug did not significantly reduce the risk of mortality in severely ill patients but was more beneficial when given early in treatment.

Since then, we’ve seen the introduction of antiviral pills, including molnupiravir from Merck and Ridgeback Biotherapeutics and Paxlovid from Pfizer.

Clinical trial data has shown Merck’s pill reduces the risk of hospitalization and death for patients who have symptoms and are at risk of severe illness by 30%, while Pfizer’s pill reduces the risk by nearly 90%.

People following mitigation measures

“I think the population’s consciousness around infectious disease is completely changed,” Brownstein told ABC News. “That wouldn’t necessarily mean for everyone but, for a large segment of the population, there’s a hyper-awareness around infectious disease that has led to significant behavior changes.”

This means that even as mask mandates and other mitigation measures have been removed, everyday Americans are being more thoughtful about staying home when sick, about wearing a mask in public situations or testing before attending a gathering, the experts say.

Chin-Hong said this is different from what he’s seen during winters before the pandemic.

“In the old days before the pandemic, people were just milling around,” he said. “And because there’s a lot of awareness that [at-home] tests may be negative early on for COVID, people just stayed home and did all the measures and isolated.”

He added that this likely also helped protect people from other diseases that were circulating this past winter including influenza and RSV.

Importance of staying vigilant

The experts told ABC News it’s important to remain vigilant because a new, more transmissible variant or a new outbreak could easily lead to another wave in the U.S.

“I think, in general, having a bunch of infections one year before helps with the next year, because you do carry across some immunity,” Chin-Hong said. “With COVID, who knows? It all depends on when people are losing immunity and what the rules are on boosting, which might happen in the fall.”

Earlier this year, it was revealed the U.S. Food and Drug Administration is considering a new COVID-19 vaccine strategy that would see Americans getting a single annual shot, similar to the flu vaccine.

According to briefing documents, the new approach would simplify public health messaging on when to get COVID vaccines, with the hope that making the guidance easier for people to understand could potentially increase vaccination rates in the U.S.

“I think that ultimately the trend will likely be towards less and less severe surges,” Brownstein said. “I don’t think it’s definitively predicted that we’ll always see smaller surges. There’ll be some variation that results from the factors of what variants circulating, what level of immunization is in the population, behavior.”

He continued, “So we can’t fully predict, but the overall trend over the coming year should be towards milder and milder surges.”

Copyright © 2023, ABC Audio. All rights reserved.

FDA approves Pfizer’s new nasal spray treatment for migraines

FDA approves Pfizer’s new nasal spray treatment for migraines
FDA approves Pfizer’s new nasal spray treatment for migraines
SCIENCE PHOTO LIBRARY/Getty Images

(WASHINGTON) — The U.S. Food and Drug Administration has approved Pfizer’s newest drug on the migraine market, Zavzpret (zavegepant) — the first and only migraine treatment of its kind to be offered in nasal spray.

The drug has shown in clinical trial data to provide rapid pain relief in as fast as 15 minutes for migraine sufferers, with relief lasting up to 48 hours, Pfizer said.

Migraines are one of the most common debilitating medical conditions, said Dr. Leah Croll, a board-certified neurologist at the Lewis Katz School of Medicine at Temple University. Nearly 40 million Americans suffer from migraines, according to the National Headache Foundation.

“They often interfere with daily functioning, keeping patients away from their work and unable to enjoy time with their loved ones. The faster we can bring relief to people suffering with a migraine attack, the sooner we can give them back that lost time,” Croll told ABC News.

According to the National Institute of Neurological Disorders and Stroke, migraines are a type of headache caused by activation of nerve fibers in the wall of brain blood vessels that cause recurrent attacks of moderate to severe throbbing and pulsating pain. CGRP, short for calcitonin gene-related peptide, is a chemical messenger in the brain that plays a role in pain modulation and inflammation.

Zavzpret works by blocking CGRP’s signals, according to Pfizer.

At least 60% of migraine sufferers also experience nausea, making pills difficult to swallow. By the time you take a pill, it’s often too late to quash a migraine because the digestive system shuts down, said Dr. Kate Mullin, a board-certified neurologist at the New England Institute for Neurology and Headache who helped conduct the trial for Zavzpret.

“You can’t absorb oral medications when you’ve got what’s called gastroparesis of migraine. Your gut pretty much falls asleep and is not in a place to absorb medications effectively for many migraine sufferers. A nasal spray helps bypass the gut altogether to optimize absorption,” Mullins told ABC News.

Currently, the other non-pill rapid migraine relief medications on the market are in injection form and a nasal spray, but those are a class of medication known as triptans.

“If you have the option of a nasal spray or an injection to stop your headache and you’re already miserable, doing an injection is the last thing you want to do. The nasal spray is far more appealing,” Mullins said.

Unlike triptans, there is no current evidence that CGRP-related medications can’t be used in people who have problems with their blood vessels, including people with coronary artery disease, according to Mullins.

Data from the trial doesn’t show evidence of rebound headaches or medication overuse headaches — headaches ironically caused by using migraine medication too often — another added benefit of this formulation, Mullins said.

The most common side effect experienced by participants in the trial was a temporarily altered sense of taste known as dysgeusia, experienced in about 20% of the nasal spray users, she said.

If you are experiencing frequent or abnormally painful headaches, experts say to talk with your doctor.

According to Dr. Croll, “Anytime someone is experiencing headaches that are interfering with their ability to function normally, in their regular life, they should talk to a neurologist about what the treatment options are.”

Mallory Rowley is a fourth-year medical student and a member of the ABC News Medical Unit.

Copyright © 2023, ABC Audio. All rights reserved.

Nationwide shortage of asthma medication albuterol could worsen in hospitals

Nationwide shortage of asthma medication albuterol could worsen in hospitals
Nationwide shortage of asthma medication albuterol could worsen in hospitals
Getty Images/Roberto Jimenez Mejias

(NEW YORK) — A nationwide shortage of the asthma medication albuterol has been ongoing since last fall and experts fear it’s only expected to get worse.

Albuterol can be taken in several forms but it’s the aerosolized solution used in a nebulizer in hospitals that the U.S. Food and Drug Administration put on its drug shortage list in late October. This shortage poses the greatest challenge for hospital settings where it is used most commonly but can be a problem for those that use this form of the drug at home.

This shortage only impacts a very specific dosage form of the medication generally used in hospitals. The FDA says it has been “working closely with manufacturers and others in the supply chain for months to understand, mitigate and prevent or reduce any related impacts.”

Although it’s not clear what prompted the initial constrained supply, the FDA has been tracking the shortage.

Generic drug manufacturer Akorn Pharmaceuticals filed for Chapter 7 bankruptcy last month, according to documents viewed by ABC News, and reportedly closed its U.S. facilities, knocking out one maker of albuterol.

The FDA updated its drug shortage page on March 1 to show Akorn’s albuterol inhalation solution is “not available” due to “no new manufacturing of product.”

This leaves Nephron Pharmaceuticals, based in South Carolina, as one of the only remaining primary manufacturers of liquid albuterol.

“We are currently producing Albuterol as fast as possible to deliver to the market — and to patients — to address this shortage,” Nephron CEO Lou Kennedy told ABC News.

In a statement posted online Wednesday night, the FDA said, in part, that it’s “working to address a shortage of a particular form of albuterol — a medication that is used to treat breathing conditions. It is important to note that this shortage does not impact albuterol inhalers for personal use.”

“We recognize the potential impact that intermittent availability of certain drug products can have on providers & patients. To help meet demand, FDA has reiterated that outsourcing facilities may compound the specific product that’s in shortage to help increase supply,” it continued, in part. “The FDA continues to explore all available regulatory levers to help assure supply — including exercising discretion for potential temporary importation by foreign suppliers.”

Local pharmacies said they have been struggling to stock albuterol over the past few months and are worried the closure of Akorn facilities will make it harder.

“The albuterol solution has been in short supply for some time. It’s hard to get it in stock,” Jim Stage, owner of Lloyd Pharmacy in Saint Paul, Minnesota, and a pharmacist, told local ABC affiliate KSTP. “We’re checking secondary and tertiary vendors if our primary vendor doesn’t have it, so it’s just creating a little bit more legwork on our part.”

What is albuterol?

Asthma is an inflammatory disease that causes airways in the lungs to constrict and prevents normal breathing. It affects more than 25 million Americans, according to the Centers for Disease Control and Prevention.

Albuterol is a medication that helps open these constricted airways. It works by activating the beta receptors in the lungs, which helps the airways open and relax so asthma sufferers can breathe more easily.

Inhaled albuterol can be given through an inhaler or as an aerosolized solution through a nebulizer machine. The aerosolized solution is the type currently facing a national shortage.

This solution is sometimes used at home for infants and young children who have difficulty using an inhaler, but it is used most commonly in hospital settings to treat a range of breathing problems associated with wheezing that includes asthma and some respiratory infections.

“This is a lifesaving medication that we need to have on demand and available when patients needed,” Dr. Juanita Mora, national volunteer medical spokesperson for the American Lung Association, told ABC News.

Mora said she has witnessed how distressing this shortage has been for her patients and families and warned that the pollen season is around the corner.

“As pollen levels rise, they are a huge trigger for asthma. I want to make sure that everyone’s asthma COPD emphysema long-haul COVID is well optimized before we head into that season,” Mora said.

Are there alternatives?

“Don’t panic,” Dr. David Khan, past president of the American Academy of Allergy, Asthma & Immunology, told ABC News. “A lot of this issue is mainly, I would say, amongst hospitals, and they’re looking at other alternative sources for liquid albuterol.”

Khan explained that the albuterol inhalers are just as effective as nebulized albuterol, adding, “I think this is a common misconception. Patients just generally need to use a little bit more puffs of their Albuterol inhaler, and it’ll work the same as the nebulizer machine.”

For patients admitted to the hospital, or infants unable to use an inhaler, one alternative medication to albuterol is levalbuterol.

Although similar, studies have had mixed results. One study from 2003 found substituting levalbuterol for albuterol in emergency department care “significantly reduced the number of hospitalizations.”

However, a meta-analysis in 2013 showed levalbuterol was not “superior” to albuterol regarding efficacy and safety, and suggested not using it over albuterol for acute asthma.

It’s unclear if every day Americans are having trouble filling prescriptions. A Walgreens spokesperson told ABC News it is “able to meet patient demand/needs at this time.”

Other pharmacy chains including CVS Health, Rite Aid Corp., Kroger Inc. and Albertsons Inc. did not return ABC News’ request for comment.

How are asthma attacks prevented?

People with lung diseases like asthma or COPD can have more severe complications from respiratory viruses and pneumonia. To prevent these illnesses, experts say to stay up to date on all vaccines, including Covid-19 boosters and annual flu shots and to practice good hand washing.

It is also important to know and avoid asthma triggers. Each individual’s trigger may be different, but common triggers include seasonal allergies, carpets, pets, mold and tobacco smoke, according to the CDC.

When using an inhaler, proper technique is very important. The American Lung Association says people should make sure they are always using a spacer with an inhaler.

If frequently using albuterol, talk to your doctor about daily medications that help control asthma symptoms in addition to albuterol.

Mora urged people not to panic or hoard liquid albuterol because they are afraid of the shortage and says doctors are asking the FDA to act urgently to solve this problem.

“We are urging the FDA to get ahead of this problem before it becomes disastrous,” Mora said.

ABC News’ Sony Salzman and Karen Travers contributed to this report.

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FDA says mammogram facilities must notify women if they have dense breast tissue to reduce cancer risk

FDA says mammogram facilities must notify women if they have dense breast tissue to reduce cancer risk
FDA says mammogram facilities must notify women if they have dense breast tissue to reduce cancer risk
Sarah Silbiger/Getty Images

(WASHINGTON) — In a major effort to improve breast cancer prevention, the FDA will now require mammogram facilities to inform women if they have dense breast tissue.

About half of women have dense breast tissue, and many don’t know it. Doctors say having dense breast tissue does not pose an immediate threat to health, but it does increase breast cancer risk.

“Dense breast tissue is a common finding on mammograms, especially in younger women,” said Dr. Hal Burstein, a breast oncologist at Dana-Farber Cancer Institute.

“It does not mean that a woman has breast cancer,” Burstein said. “It means she might be at slightly greater risk of breast cancer, and that the mammogram is slightly less helpful for early detection.”

Medical guidelines suggest most women should start getting regular mammograms starting at age 50, or even earlier depending on additional risk factors. Now, with this new FDA rule, mammogram facilities will be required to inform women if their results showed they have dense breast tissue.

Previously, more than half of states had this requirement, according to the FDA’s Chief Medical Officer Dr. Hilary Marston. Now, it will be a nationwide requirement, and facilities have 18 months to comply.

“The FDA wants all women to have access to this information,” Burstein said.

Armed with the right information, women with dense breast tissue may be able to talk to their doctor about whether or not they need to take additional steps to make sure breast cancer isn’t missed — such as more frequent screenings or additional imaging, like an ultrasound or MRI, Marston said.

About one in every eight women in the U.S. will be diagnosed with breast cancer in her lifetime.

“It has been known for a long time that [dense breast tissue] makes it more difficult to see a cancer on a mammogram when it exists,” Marston told ABC News. “What’s evolved more recently in the science is an understanding that having dense breast tissue in and of itself is an independent risk factor for breast cancer.”

“The other important thing to know here is that you can’t tell just from the feel of your breasts, whether your breasts are dense or not. This is really a finding that is seen on mammography,” Marston said.

Marston said she hopes the FDA’s new rule encourages more women to seek mammograms they may have missed or delayed during the COVID-19 pandemic.

“It is so important at this point that women really go out, schedule your mammogram, get it done,” Marston said. “Find a local facility — and you can be assured that that local facility will provide a quality product.”

Copyright © 2023, ABC Audio. All rights reserved.

Transgender health care is now protected in Minnesota

Transgender health care is now protected in Minnesota
Transgender health care is now protected in Minnesota
Andy445/Getty Images

(ST. PAUL, Minn.) — Minnesota Gov. Tim Walz signed an executive order protecting and supporting access to gender-affirming health care for LGBTQ people in the state on Wednesday.

The move comes amid Republican-backed efforts across the country to limit transgender health care for minors and young adults.

“Minnesota strives to be a welcoming and supportive place for LGBTQIA+ community members,” the executive order read. “We uphold the essential values of One Minnesota when all people, including members of the LGBTQIA+ community, are safe, celebrated, and able to live lives full of dignity and joy.”

Walz called gender-affirming care a “deeply personal decision” for transgender patients and their families.

Numerous medical organizations, including the American Medical Association, the American Academy of Child and Adolescent Psychiatry, the Centers for Disease Control and Prevention have said that access to gender-affirming care is essential to the health and wellness of gender diverse people.

Studies have shown that gender-affirming care can be life-saving for transgender and nonbinary children and adolescents, promoting positive mental and physical health and well-being.

States like Tennessee, Arizona, Utah, Arkansas, Alabama, Mississippi, South Dakota and Florida have passed policies or laws restricting transgender health care. Supporters of these laws believe that gender transitioning is harmful to youth and young adults. Some say patients should wait until they are older to make this kind of health decision.

In Minnesota, several legislative protections for LGBTQ people are in front of lawmakers, including banning conversion therapy and establishing Minnesota as a “Trans Refuge” state.

More than 388 anti-LGBTQ bills have been introduced in 2023 alone, according to the ACLU.

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Parents rent billboard to raise awareness of falling trees after kids’ deaths

Parents rent billboard to raise awareness of falling trees after kids’ deaths
Parents rent billboard to raise awareness of falling trees after kids’ deaths
Courtesy of Clark family

(NEW YORK) — Crystal and Brian Clark are on a mission to save lives after their children were struck and killed by a falling tree during a family camping trip last year.

The Clarks started a billboard campaign to honor their children, 9-year-old Xander and 8-year-old Ziva, who they described as “very loving” and “kindhearted,” and shine a light on the hidden dangers of falling trees.

Their sign includes a photo of Xander and another photo of his sister Ziva, alongside a message that reads: “Check your trees! After storms, heavy rains and windy days. You could save a life! Xander and Ziva Clark killed by a fallen tree 4/23/22.”

“My whole thought of a billboard came a few months after the kids had passed, to where I can share who they were and how great of kids they were, but also spread awareness of something that isn’t ever thought of really by a parent until it actually affects you or a family member,” Crystal Clark told ABC News’ Good Morning America.

“You expect your child to fall out of a tree, not a tree to fall on them,” Brian Clark added. “But apparently, deaths by tree are not as uncommon as we all thought. So to me, that’s why it is important to get the word out.”

The Clarks had gone for a golf cart ride on April 23, 2022, a day Crystal Clark remembered as a sunny one but also marked by strong winds. She said they were driving under a “canopy of trees” at a Cloverdale, Indiana, campground when the unthinkable happened.

“We heard a very loud noise, almost sounded like a plane crashing into the woods,” Crystal Clark said. “Next thing we know, the tree had fallen. It was too late for us to notice it and I shouted, ‘Our babies!’ and Brian and I got off the golf cart and that’s where we saw that they were gone.”

“It was just a sight that you hoped you never had to see,” Brian Clark added.

In the months since their children’s unexpected deaths, the Clarks said they started hearing from other people with similar heartbreaks.

“After we went through our incident with the children, we realized it was more frequent than anybody really ever talked about,” Brian Clark said. “The more we heard from people, the more people that reached out and said, ‘We know what you’re going through.'”

Last Sunday, a mother hiking with her son and his Boy Scout troop in Cupertino, California died after a tree fell on her.

The U.S. Forest Service notes that trees can fall at any time, without warning, and warns people to be alert for trees on windy days or after an ice storm or snowstorm. The agency also said trees with “structural defects” can have a lack of needles, bark or limbs and those with internal rot may have “conks, broken tops, basal scars, numerous downed limbs, ants, or an abundance of woodpecker holes.”

“Look up while on trails, especially when it’s windy,” the Forest Service advises. “Stay out of the forest when there are strong winds that could blow down trees. If you are already in the forest when winds kick up, head to a clearing out of reach of any potential falling trees.”

After hearing of the Clark family’s motivation to turn their heartbreaking tragedy into purposeful action, Lamar Advertising Company decided to sponsor nine additional digital billboards in the central Indiana area, along Interstate 70.

“The digital billboards actually went up last Thursday. It was kind of nice because that was my husband’s birthday. So that was a nice surprise for us,” Crystal Clark said.

Brian Clark said they “greatly appreciate” the company’s support and generosity and hope their important message can help others.

“If you save one more life, that to me, is a good thing,” he said.

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