Health

(WASHINGTON) — The Biden administration on Tuesday unveiled the first 10 prescription drugs that will be subject to price negotiations with Medicare, marking a milestone for Democrats in their yearslong push to lower rising health care costs.

The list includes Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Imbruvica, Stelara, Fiasp and NovoLog.

President Joe Biden, in a statement, said the medications are “among the most common and costly prescriptions that treat everything from heart failure, blood clots, diabetes, arthritis, Crohn’s disease — and more.”

“For far too long, Americans have paid more for prescription drugs than any major economy. And while the pharmaceutical industry makes record profits, millions of Americans are forced to choose between paying for medications they need to live or paying for food, rent, and other basic necessities,” Biden said. “Those days are ending.”

The impact won’t be immediately felt, however, as the negotiations will occur this year and next with the new prices becoming effective in 2026.

The Medicare Drug Price Negotiation Program is a result of the Inflation Reduction Act, one of Biden’s key legislative victories. It allows the government to directly broker with drug manufacturers for the first time in the history of the program, which provides health insurance coverage to 65 million people, including 57 million seniors.

Biden will deliver remarks in the East Room of the White House on Tuesday afternoon to mark the occasion. There, the White House said he will be joined by a Medicare beneficiary who relies on prescription medications to treat chronic conditions.

Medicare enrollees taking the 10 drugs selected for negotiation paid a total of $3.4 billion in out-of-pocket costs for the medications in 2022, according to the Department of Health and Human Services.

Under the Inflation Reduction Act, the federal government can select up to 15 more drugs for negotiation in 2027, another 15 drugs for 2028 and up to 20 more drugs each year after.

President Biden, in a nod to his 2024 reelection message, said taking on “Big Pharma” is part of his “Bidenomics” vision of building the economy from the middle out and bottom up.

“Let me be clear: I am not backing down,” Biden said on Tuesday. “There is no reason why Americans should be forced to pay more than any developed nation for life-saving prescriptions just to pad Big Pharma’s pockets.”

The drug industry, in response to the announcement, hit back on the program.

“Giving a single government agency the power to arbitrarily set the price of medicines with little accountability, oversight or input from patients and their doctors will have significant negative consequences long after this administration is gone,” Pharmaceutical Research and Manufacturers of America (PhRMA) President Stephen J. Ubl said in a statement.

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(NEW YORK) — With one delivery, Graham and Stephanie Freels became first-time parents, times five.

Stephanie Freels, 27, gave birth on June 4 to five babies — four girls and one boy — delivered via emergency cesarean section.

Over the weekend, she and her husband and their five infants returned to their home in Washington state for the first time as a family of seven.

“It’s amazing having them at home,” Stephanie Freels told ABC News’ Good Morning America. “And it’s so nice not having them go back and forth to the NICU.”

The “Freels Five,” as the quintuplets have been nicknamed, came into the world as a surprise after Stephanie and Graham Freels said they struggled with infertility for around five years.

The couple said they learned in late December that they were pregnant after undergoing an ovulation induction and several rounds of intrauterine insemination, or IUI.

Just after the New Year, they learned they were going to become first-time parents to not just one but five babies.

The news upended the plans the couple had made to move from Stephanie Freels’ parents’ home into their own apartment.

“At the beginning of December, we told her parents that we were moving out and we had a lease signed at a small apartment,” Graham Freels told GMA, adding that they then had to quickly cancel the lease. “I called up the landlord and I said, ‘I think we’re about to have a lot of kids, and I don’t think that apartment is going to work for us anymore.'”

The quintuplet pregnancy upended the state the Freels lived in too after Graham Freels researched doctors for higher order multiple pregnancies and chose to use an expert in Phoenix, Arizona.

In March, the Freels relocated temporarily to Phoenix so they could be cared for by Dr. John Elliott, a maternal and fetal medicine specialist, who they said helped them keep a positive “can-do attitude” about the prospect of having five babies at once.

Graham Freels said he continued working his full-time job remotely in Phoenix, while Stephanie Freels took on the full-time task of managing her quintuplet pregnancy.

She said she did that while also battling hyperemesis gravidarum, a form of “extreme, persistent nausea and vomiting during pregnancy,” according to the National Institutes of Health.

“I think that was the hardest part of pregnancy for me, that I had to try to meet that [calorie] goal,” Stephanie Freels said. “I didn’t really consistently eat solid foods until I was about 23 weeks pregnant.”

The Freels said their medical team told them another goal was to carry the pregnancy to at least 34 weeks, but in early June they went to the hospital when Stephanie Freels was 27 weeks pregnant, because she was experiencing abnormal pain and swelling.

At the hospital, she said she learned she was already six centimeters dilated and in labor.

Andrea Hassler, nursing director of women and infant services at Dignity Health St. Joseph’s Hospital, where Stephanie Freels gave birth, told GMA the medical team had about one hour in the middle of the night to mobilize for the delivery.

Hassler said the Freels arrived at the hospital around 10 p.m. local time and the babies were delivered less than three hours later.

“It was upwards of 20 people in the delivery room because each baby has its own team of nurses, respiratory therapists and physicians to help transition them after birth,” Hassler said. “And then Stephanie had her own team on the obstetrical side as well to ensure that she was safe during the delivery as well.”

The quintuplets — Adelyn, Eliana, Linnea, Fisher, and Harper — each weighed around 2 pounds at birth, according to Hassler. Though they spent several weeks in the neo-natal intensive care unit, she said the quintuplets had a “pretty uncomplicated course” medically after being born so early.

“As expected, they did need some respiratory support in the beginning,” Hassler said. “And then it was really a focus on being able to have those babies grow outside of mom’s womb up into the healthy babies that you see today.”

Fisher, the only boy, was the last of the quintuplets to be discharged from the NICU and went home Aug. 19.

Graham Freels said that in the last two weeks of having most of the quintuplets at home, they had gone through over 250 diapers and counting.

The quintuplets are fraternal, not identical, so they are able to tell the babies apart, he noted.

Now that they are back home in Washington, the “Freels Five” and their parents are all living at Stephanie Freels’ parents’ home again, where there are plenty of hands to help.

Both Graham and Stephanie Freels said they are beyond thankful for the family and friends who are helping with the babies, as well as strangers who have stepped up to help by sending money, cooking meals and offering their well-wishes.

The couple also said they are extremely thankful for the nurses and doctors who have cared for them and their babies for the past year.

“They truly are just amazing people and just the amount of care they put into taking care of not only our babies, but every single baby they’re working with,” Graham Freels said of the medical staff. “They’re doing amazing things.”

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(NEW YORK) — Semaglutide, the active ingredient in drugs like Wegovy and Ozempic, is also effective at reducing symptoms of heart failure, new research shows.

A study published this month in the New England Journal of Medicine followed over 500 patients who were both overweight and had a specific type of heart failure known as heart failure with preserved ejection fraction.

Over the course of one year of taking weekly injections of semaglutide, the patients not only lost weight but also had significant reductions in symptoms of heart failure and saw an improvement in their ability to exercise, according to the study.

Heart failure, or congestive heart failure, happens when your heart doesn’t pump enough blood to meet the needs of your body, according to the National Institutes of Health. It impacts more than 6 million adults in the United States, meaning an accessible treatment for the condition could have widespread impact. About half of patients with heart failure have the specific kind this study looked at.

Likewise, the potential success of semaglutide in improving heart health could transform the compound’s popularity even further.

Interest in semaglutide has surged over the past year for its role in helping people lose weight.

Obesity is a condition that affects nearly 42% of the population and is associated with over $170 billion in medical costs in the U.S., according to the Centers for Disease Control and Prevention.

Novo Nordisk, the company that funded the most recent study, makes both Wegovy and Ozempic, the two most popular drugs that have semaglutide as the active ingredient.

The U.S. Food and Drug Administration has approved Ozempic as a treatment for Type 2 diabetes — a chronic condition in which the body doesn’t respond well to insulin — alongside diet and exercise if other medications cannot control blood sugar levels well enough.

Although Ozempic is not explicitly approved for chronic weight management, it can be prescribed off-label and used safely for people who are obese.

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.

Both drugs work by slowing down movement of food through the stomach and curbing appetite, thereby causing weight loss.

Earlier this month, Novo Nordisk released preliminary results of a study that found Wegovy also helped lower the risk of heart attacks and strokes, according to the company.

Wegovy lowered the risk of major cardiovascular events by 20% in a clinical trial that included over 17,000 adults ages 45 and older who have a history of cardiovascular disease and are overweight or obese, according to the Novo Nordisk-funded study.

As a result of the trial’s findings, Novo Nordisk said it plans to file for a “label indication expansion” for the drug, meaning it could be available beyond obesity, and with greater insurance coverage.

Without insurance coverage, the cost of medications like Wegovy and Ozempic can run more than $1,000 a month.

 

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(NEW YORK) — Just weeks into the new school year, districts in multiple states are canceling in-person classes for several weeks due to respiratory viruses, including COVID-19, among students and staff.

Two school districts in Kentucky — Lee County School District and Magoffin County Schools — said they were closing due to “widespread illness.”

LCD canceled classes on Tuesday and Wednesday and switched to virtual classes on Thursday and Friday.

“We’re seeing a lot of illness being reported consistent with COVID and influenza,” Scott Lockard, public health director for the Kentucky River District — which includes Lee County — told ABC News. “Lee County had a surge of cases and attendance dropped below the threshold needed to stay open, so they closed.”

He said there’s been an uptick in positive COVID-19 cases but the true number of infections may be higher due to at-home test results not being reported to the health department.

Lockard said there is a concern that cases could increase heading into the fall and winter and encouraged people to get vaccinated with the flu and new COVID booster to prevent others from getting sick.

“Stay home when you’re sick,” he said. “Previously it was a seen as a badge of courage, ‘Oh I haven’t missed a day of work in 40 years. I went to work sick.’ We don’t want to see people saying that. We want, ‘I had symptoms, so I stayed home because I’m considerate of my coworkers.'”

Meanwhile, Magoffin County Schools announced it would be closed Thursday and Friday and classes would be remote.

Pete Shepherd, director of the county’s Public Health Department, told ABC News there were reports of illnesses including COVID, strep and stomach viruses during the first two weeks of school.

During the third week, COVID cases kept increasing and attendance fell to 83% on Wednesday, leading to the decision to close the school.

Shepherd said Monday and Tuesday there were a combined 40 cases of COVID in the county reported by doctors, mostly among children. Additionally, he said many parents called the department to let them know their child was sick.

“The good news is the symptoms have not been as severe,” Shepherd said. “The kids are not as sick. Small temperature, feeling bad, flu-like symptoms.”

He added that because precautions related to COVID-19 have been relaxed, including masking, he expected there will be “a lot more flu cases” compared to seasons during the pandemic where there were few to no cases.

In Texas, Runge Independent School District — located on Karnes County, 50 miles southeast of San Antonio — told parents in a letter that it would be closing from Aug. 22 through Aug. 29 and canceling all extracurricular activities due to COVID cases, according to ABC affiliate KSAT.

“The safety and well-being of our students, staff, and community is a top priority,” superintendent Hector Dominguez Jr. said in a statement.

The district did not immediately respond to ABC News’ request for comment. On the district’s website, the COVID tracker shows 10 active cases in Runge ISD as of Aug. 21, all among staff.

According to the latest report from Texas Health and Human Services, new probable and confirmed COVID-19 cases in the state have increased 29% in recent weeks.

COVID hospitalizations have also increased by about 10% from 992 to 1,096, but it’s not been linked to a rise in deaths with COVID fatalities decreasing in the state.

Nationally, COVID hospitalizations increased for the fifth consecutive week, according to data from the Centers for Disease Control and Prevention.

For the week ending Aug. 12, hospitalizations rose from 10,370 to 12,612, CDC data shows. Despite the increase, it’s still among the lowest hospitalizations recorded since the pandemic began.

 

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(NEW YORK) — Although lunch boxes and insulated containers to ensure temperature control have largely taken the place of brown paper bags at lunchtime, there are still a few easy-to-follow food safety practices that every parent or guardian should keep in mind before sending students off to school this fall.

According to the U.S. Department of Agriculture, school and work lunches can become dangerous if not kept at ideal temperatures — hot food must remain hot, while cold foods must be kept cold — otherwise, bacteria can multiply and make a person sick when they finally eat it.
Easy protein-packed breakfast ideas, dietitian-backed grocery shopping tips

Food safety tips, best practices for school lunch

USDA Food Safety and Inspection Service public affairs specialist Kenneth King recently shared his top tips for caregivers to “make the food safety honor roll” in a blog post for the agency. Check out his suggestions to implement in your own kitchen this school year.

Keep cold foods cold and hot foods hot

The USDA recommends using an insulated lunch box to keep food safe.

“Paper bags are risky because they don’t allow for proper cooling of food. Always use at least two cold sources like frozen gel packs, frozen juice boxes, or frozen water bottles to keep foods cold,” he wrote. “Foods that sit out at room temperature are at risk of entering the ‘Danger Zone,’ which is between temperatures of 40 and 140 degrees F, where bacteria can multiply quickly and cause illness.”

By that same logic, King said hot foods like soups or stews should be stored in an insulated container to keep the food hot at 140 F or above until lunchtime.

Easiest lunchbox prep tips and tricks for back to school

While a thermos is more commonly used for hot soups, pasta and stews, it can also be used for cold dishes like salad.

For best results, rinse out a thermos with very hot water to heat it before adding hot soups or rinse it out with ice water to chill the thermos before adding cold things.

Meal prepping tips

“If preparing lunch the night before school and refrigerating overnight, take the bag or lunchbox out just before leaving home,” King wrote. “Pack just the amount of perishable food that can be eaten at lunchtime. That way, there won’t be a problem about the storage or safety of leftovers.”

Four rules for school lunch food safety

Because food is particularly susceptible to contamination in a variety of ways, including the potential spread of germs during the prep and packing process, here are four ways to ensure safe handling and storing to reduce the risk of foodborne illness.

Clean: Wash hands with soapy water for 20 seconds before touching food. If your hands have a cut or sore, wear gloves while prepping the meal.

Separate: Keep raw meats separate from ready-to-eat food.

Cook: Use a food thermometer in the thickest point to check that meat and poultry are fully cooked to a safe internal temperature — 165 F for poultry, ground and stuffed meats, and 145 F for seafood, steaks and roasts.

Chill: Refrigerate or freeze foods promptly when first purchased. Discard any foods that are left at room temperature for over two hours.

Additional expert advice to avoid foodborne illness

According to the National Library of Medicine and Centers for Disease Control and Prevention, higher risk foods include undercooked red meats and poultry, eggs, unpasteurized cheese, dairy products, raw sprouts, and raw fish or shellfish.

The symptoms of foodborne illnesses vary, but typically include “stomach problems or stomach upset, including nausea, vomiting, and/or diarrhea,” the institute states. “Foodborne illnesses may be severe and fatal. Young children, older adults, pregnant women, and people who have a weakened immune system are especially at risk.”

To avoid cross-contamination during prep work, health experts advise washing cutting boards and utensils with hot water and soap after preparing each food item and separating meat, poultry, and seafood from other foods.

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(NEW YORK) — The updated COVID vaccine should become available in mid-September, along with a likely recommendation that everyone should get the booster shot, U.S. health officials said this week.

The timeline was laid out by officials with the Centers for Disease Control and Prevention and Food and Drug Administration in a briefing with reporters.

“Vaccination is going to continue to be key this year because immunity wanes and because the COVID-19 virus continues to change,” a CDC official said. “For those reasons, vaccines remain the best protection against hospitalization and death. And in the case of the COVID vaccines they also help reduce the likelihood of ‘long COVID.'”

Only 56 million Americans – about 17 percent of the population – have received an updated booster, according to the CDC. That’s compared to the close to 81 percent of Americans who completed the primary doses.

The good news is that 97% of individuals in the U.S. ages 16 and over have protective immunity from COVID-19 either through vaccination, prior infection or both. That immunity has translated into fewer hospitalizations.

While COVID hospitalizations in the U.S. have been on the rise in recent weeks, levels are still three times lower than the same time last year – and six times lower than in 2021 after the first vaccines rolled out.

An FDA official told reporters that it’s likely that older individuals and those who are immunocompromised might need to get more than one vaccine, similar to current recommendations. Many health care providers recommend that people 65 and over get a second dose a few months after the initial shot to boost immunity.

Officials also will be recommending annual flu shots for the general population and RSV shots for certain vulnerable populations.

The CDC panel (ACIP) meets Sept. 12. While this can change, it suggests the FDA is working toward approval Sept. 11.

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(NEW YORK) — Health officials are urging the public to plan ahead when it comes to scheduling their vaccinations, as this year may look a little different than previous seasons.

With fall approaching, public health officials are spreading the word about newly approved vaccines and immunizations that can help protect against seasonal viral illnesses.

Since the start of the COVID-19 pandemic, many hospitals are now feeling the burden of the so-called “tripledemic” of COVID, flu and RSV.

This year, adults in the U.S. can expect to see flu shots and updated COVID boosters at their local pharmacy or at their doctor’s office. In addition, new immunization options will be available for RSV — a virus that kills thousands each year.

RSV is a viral infection that leads to mild symptoms for most people, but it can be deadly for the oldest and youngest members of society young children and senior citizens.

Now, adults over 60 will be able to get vaccinated to reduce the risk of RSV. Similar to flu vaccines, the new RSV vaccines are available at major pharmacy retailers including CVS, Rite Aid and Walgreens. The Centers for Disease Control and Prevention recommends that people 60 and older speak with their doctor before receiving the vaccine.

“We used to not have anything good when people get sick,” Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco, told ABC News. RSV “was an undercover disease…now it’s even more important to get vaccinated.”

Meanwhile, babies will also have a new option to reduce their risk of RSV. A new immunization called Beyfortus was recently approved for infants younger than 8 months who are entering their first RSV season. Some high-risk infants may be eligible for a second shot the following year.

“We’re incredibly excited to see an RSV vaccine on the market this fall for those greater than 60 and thinking about risk benefit in combination with their primary care provider, as well as a longer acting monoclonal antibody to protect those who are youngest from this disease,” Dr. Anne Zink, the president and chief medical officer for the Alaska Department of Health, told ABC News.

In addition, a third type of RSV immunization might also be available this year, pending CDC sign-off. It’s a vaccine that will be given during pregnancy, with the idea of passing immunity to newborns. The CDC is slated to meet within weeks to discuss their recommendations for this vaccine — one of the final regulatory steps before this vaccine hits pharmacy shelves.

In addition to protections against RSV, there is an updated COVID booster expected to protect against newer variants that are circulating this season.

The COVID vaccine is set to target newer variants in the U.S. and is expected to offer protection against severe disease and death, with experts saying older adults and immunocompromised people would benefit the most.

“I think I can predict with 100% certainty that people within the high-risk groups: 65 and older, immunocompromised, pregnant will be recommended for the [COVID] vaccine. There is some debate regarding young and healthy adults, children and adolescents and recommendations will come out in September,” said Dr. William Schaffner, Professor of Infectious Disease at Vanderbilt University School of Medicine.

Experts say the upcoming vaccine schedule will be simpler than in past seasons.

“This is a simplification from the vaccine recommendations of the past few years […] because on the COVID vaccine front, we will now likely have one vaccine shot that’s going to be recommended every year. That’s a simplification from random boosters that have been recommended at various times prompted by the changing variants of COVID. So, we’re looking forward to a much more simplified regimen and that’s what’s coming down this fall,” Dr. Joseph Kanter, a state health officer at the Louisiana Department of Health, told ABC News.

Meanwhile, seasonal influenza still kills between 12,000 to 52,000 people every year, according to the CDC. Each year, scientists update the flu vaccine to be a better match for currently circulating variants — and this year is no different.

Most Americans — even babies — are eligible for flu shots, with current medical guidance recommending an annual shot for everyone 6 months and older.

In terms of timing, experts say the best time to get a flu shot is before Halloween, but it’s not too late to get the vaccine later in the season.

Experts agree it’s safe to get a COVID booster and a flu shot at the same time — and this may be the most convenient option for many Americans.

Because the RSV immunizations are new, experts say for now it’s best to talk to your doctor about the best time to get RSV shots.

Some experts predict that flu and RSV will return to “normal” pre-pandemic levels this year — though they caution that the tripledemic can make the situation unpredictable.

“Predicting the behavior of seasonal respiratory viruses is a hazardous occupation, but with 100% assurance, all three viruses will be active, exactly how severe we don’t know. But most of us kind of anticipate that these viruses will revert to their more conventional seasonal behavior. and for this we are prepared,” Schaffner said.

Evgeniya Jenny Rakitina, MD, MSGM, Internal Medicine Resident at NYU Langone, a member of ABC News Medical Unit.

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(NEW YORK) — Kroger and Food Lion shoppers who have purchased frozen veggies should check their freezer for products that have been recalled over potential listeria contamination.

Twin City Foods, Inc. issued a voluntary recall on Tuesday for “a limited quantity of Not-Ready-To Eat Individually Quick Frozen (IQF) Super Sweet Cut Corn and Mixed Vegetables in retail bags, due to a potential for these products to be contaminated with Listeria monocytogenes,” the company stated in an announcement shared by the U.S. Food and Drug Administration.

The Washington and Michigan-based food manufacturer recalled 22 products of various sizes and names that were distributed nationwide at retailers including Kroger, Food Lion, and Albertsons Cos. stores. According to the company’s announcement, “no other products have been affected.”

Click here for a full list with detailed product information, including product codes and expiration dates.

As of time of publication, the company said there “have been no actual consumer reports of human illness or other complaints associated with this product.”

“The recall has been initiated because finished products may potentially be contaminated with the Listeria monocytogenes, based on one customer’s 3rd party lab results for the IQF sweet cut corn,” Twin City Foods, Inc. stated.

Any consumers who may have purchased the recalled products have been urged not to consume it and to return them to the store where they were purchased for a full refund immediately.

Consumers with further questions can contact Twin City Foods through the phone number listed in the announcement on the FDA’s website.

Symptoms, side effects of Listeria monocytogenes

According to the Centers for Disease Control and Prevention, listeria can cause severe illness “when the bacteria spread beyond the gut to other parts of the body” after a person consumes contaminated food. Those at higher risk include pregnant people, those aged 65 or older, or anyone who has a weakened immune system, the CDC says.

“For people who are pregnant, Listeria can cause pregnancy loss, premature birth, or a life-threatening infection in their newborn,” the CDC states on its website. “For people who are 65 years or older or who have a weakened immune system, Listeria often results in [severe illness that may lead to] hospitalization and sometimes death.”

Other people can be infected with listeria, but rarely become seriously ill, according to the FDA.

According to the CDC, anyone infected with listeria may experience “mild food poisoning symptoms” such as diarrhea or fever, and many recover without antibiotic treatment.

The CDC has advised people to contact a health care provider if they think they may have eaten contaminated food and are experiencing related symptoms.

“You should seek medical care and tell the doctor about eating possibly contaminated food if you have a fever and other symptoms of possible listeriosis, such as fatigue and muscle aches, within two months after eating possibly contaminated food,” the agency states on its website. “This is especially important if you are pregnant, age 65 or older, or have a weakened immune system.”

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(SONOMA, Calif.) — California health officials have issued an advisory after several people who competed in a Tough Mudder run and obstacle course competition last weekend fell ill with as-yet unexplained symptoms.

The Sonoma County Department of Health Services (SDHS) said it has received multiple reports of rashes, fever, muscle pain, nausea and vomiting among those who participated in the event at the Sonoma Raceway, a car racetrack 30 miles north of San Francisco, on Aug. 19 and 20.

“The Tough Mudder race involved extensive skin exposure to mud. Most affected persons have pustular rash, fever, myalgias, and headache,” read the health advisory, published Wednesday.

According to the SDHS, the symptoms could be due to “a minor illness called Swimmer’s Itch,” also known as cercarial dermatitis, which is caused by an allergic reaction to certain microscopic parasites, according to the Centers for Disease Control and Prevention.

The parasites live in some species of birds and mammals. If their eggs find their way into water and hatch, the larvae can infect a certain species of aquatic snail that in turn release microscopic larvae that can burrow in the skin of humans and cause symptoms, including rashes.

However, the SDHS said the people may be experiencing a staph infection, or a more serious infection from a bacterium known as Aeromonas hydrophila.

Staph infections are caused by staphylococcus bacteria and usually only cause minor skin infections, according to the Mayo Clinic, though the infections can become more serious if the bacteria enters the bloodstream and travels to the host’s bones, heart or lungs.

Aeromonas hydrophila, however, is typically found in fresh water or sewage and, while rare, it can infect humans, with reports of complications including diarrhea, kidney disease, hemolytic uremic syndrome – which occurs when the small blood vessels in the kidneys become damaged and inflamed, potentially leading to kidney failure – meningitis, and sepsis, according to the Public Health Agency of Canada.

“If you participated in the race and have a rash with fever or other symptoms, please see your medical provider or, if you do not have a medical provider, your local emergency department. You may wish to take this Advisory with you. Incubation period is 12 to 48 hours,” the SDHS health advisory states.

The SDHS did not immediately respond to ABC News’ request for comment, nor did organizers of the Tough Mudder event.

Tough Mudder participant Nicole Villagran told local ABC affiliate KGO TV that she did not participate in all of the obstacle course but she still found bumps on her body the next day.

“You wake up the next day and you’re like, ‘What is all this on my arm? Like, what is going on here?'” she said. “And it’s on both arms. That’s where I was digging and doing army crawls and it’s on the inside of my knees where I was pushing off of as well.”

Fellow participant Curtis Vollmar told KGO TV that 12 of the 13 people he did the Tough Mudder event with also experienced the symptoms, though they are fading.

“Pretty much gone,” he said in reference to his arms. “You can’t really see much of it but from the elbows up and knees down, I was just covered in these, like, pimply red blister-type things.”

 

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(NEW YORK) — Consumers should not purchase and immediately stop using certain eye drops due to potential bacterial or fungal contamination, according to a warning issued by the Food and Drug Administration.

The two specific products listed in the warning are Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops.

There have not been any adverse events reported at this time, according to the FDA.

The products are unapproved drugs and illegally marketed in the U.S. because they contain methylsulfonylmethane (MSM) as an active ingredient, the FDA release added.

“Patients who have signs or symptoms of an eye infection should talk to their health care professional or otherwise seek medical care immediately,” the FDA wrote in its warning.

The company that manufactures the Dr. Berne’s eye drops had verbally agreed to voluntarily recall the product, according to the FDA.

“The FDA has done a random investigation on one of my products, the 5% MSM … They found microbial growth in the sample they tested and recommended a recall on all MSM and Castor Oil products,” Dr. Berne’s said in a statement. “I am doing my own testing with samples using a 3rd party laboratory on all MSM products and will post these results here on Monday. If you have the MSM 5% Lot# 6786, please discontinue using.”

The second company, LightEyez Limited, had not responded to the FDA at the time of the release. ABC News has reached out to LightEyez for comment as well.

The industry has had recent manufacturing issues related to eye drops, prompting sampling and testing by the federal agency, which found the products were not sterile and safe to use.

A previous outbreak of contaminated eye drops was linked to at least four deaths and 14 people going blind, according to the Centers for Disease Control and Prevention. An additional 4 people eyeballs surgically removed.

Patients are still advised to stop using EzriCare or Delsam Pharma’s Artificial Tears and Delsam Pharma Artificial Ointment until additional guidance is provided by federal health authorities, according to the latest CDC guidance.

Eye infection symptoms may include yellow, green or clear discharge from the eye as well as redness of the eye or eyelid. Additionally, patients may feel increased sensitivity to light, pain, or discomfort, or experience blurry version, according to the CDC

It’s best to always wash your hands with soap and water before using eye drops to prevent infection, according to the National Institutes of Health. Additionally, you should avoid letting the tip of the eye drop bottle touch your hands, eye, or eye lid.

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