Some people are overdosing on semaglutide, FDA warns
(NEW YORK) — The U.S. Food and Drug Administration has issued a new warning about a popular medication used for weight loss.
The FDA says it has received reports of people overdosing on compounded semaglutide, giving themselves as much as 20 times more than the intended dose of the medication.
The incidents, some of which required hospitalization, involve semaglutide that is drawn from a vial and taken by injection, according to the FDA.
The agency said the dosing errors are a result of both patients measuring and self-administering incorrect doses of the medication, as well as health care providers “miscalculating” doses of the medication.
“Many of the patients who received vials of compounded semaglutide lacked experience with self-injections, according to the adverse event reports,” the FDA said in a July 26 statement. “Unfamiliarity with withdrawing medication from a vial into a syringe and coupled with confusion between different units of measurement (e.g., milliliters, milligrams and “units”) may have contributed to dosing errors.”
The agency said patients should consult with a medical professional on how to measure and administer the correct dose, and that health care providers should “provide patients with the appropriate syringe size for the intended dose and counsel patients on how to measure the intended dose using the syringe.”
Semaglutide is the active ingredient in three FDA-approved medications, Wegovy, Ozempic and Rybelsus.
While the FDA-approved medications are administered via either an oral tablet or pre-filled pens, compounded versions of semaglutide have patients draw the dose themselves from vials, which can lead to dosing errors.
Overdose symptoms of compounded semaglutide include nausea, vomiting, abdominal pain, fainting, headache, migraine, dehydration, acute pancreatitis and gallstones, according to the FDA.
People should contact their health care provider if they feel any symptoms.
The FDA is also encouraging people to report “adverse events” and “medication errors” to the agency via its online portal or by downloading and faxing an adverse event report.
The FDA has previously warned against the use of compounded semaglutide, citing safety concerns.
Compound pharmacies create their own semaglutide or tirzepatide compounds using raw ingredients. They are not the same as generic drugs, which are FDA-approved and monitored for safety and effectiveness.
There are currently no generic versions of semaglutide medications, including Ozempic and Wegovy.
“Patients should not use a compounded drug if an approved drug is available to treat a patient. Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality,” the FDA said in a safety warning earlier this year.
The warning came as many people reported turning to compounding pharmacies to get cheaper doses of semaglutide.
Without insurance coverage, the cost of medications like Ozempic, Rybelsus and Wegovy can run more than $1,000 a month.
Both Ozempic and Rybelsus are approved by the FDA to treat Type 2 diabetes, but some doctors prescribe the medication “off-label” for weight loss, as is permissible by the FDA.
Wegovy is FDA-approved for weight loss for people with obesity or who are overweight with a comorbidity like high blood pressure.
(NEW YORK) — A third death has been reported in connection to a multi-state outbreak of Listeria monocytogenes infections that has been linked to a Boar’s Head deli meat recall.
The Centers for Disease Control and Prevention announced Thursday that since a previous update on July 31, nine more cases of listeria had been reported, including one new death in Virginia.
In total, there have been 43 illnesses leading to hospitalization.
The announcement also stated that the New York State Department of Agriculture and Markets’ Division of Food Safety and Inspection “collected unopened Boar’s Head liverwurst products from retail stores and the New York State Food Laboratory identified Listeria monocytogenes” and that “[whole-genome sequencing] determined it to be the same strain as the strain making people sick in this outbreak.”
Boar’s Head previously expanded its original July 26 recall on several types of deli meats to include an additional 7 million pounds of ready-to-eat meat and poultry products that may be contaminated with listeria.
The U.S. Department of Agriculture’s Food Safety and Inspection Service initially announced that Boar’s Head Provisions Co. had recalled 71 products produced between May 10, 2024, and July 29, 2024, under the Boar’s Head and Old Country brand names.
The announcement was an expansion on a previous recall announcement amid an ongoing investigation by the CDC into an outbreak of listeria infections linked to meats sliced at delis that had sickened 34 people across 13 states.
ABC News’ Good Morning America has reached out to Boar’s Head for comment on the recall.
Details of Boar’s Head deli meat recall
The Virginia-based meat producer initially recalled approximately 207,528 pounds of products that were distributed to retail deli locations nationwide, including all liverwurst products and “additional deli meat products that were produced on the same line and on the same day as the liverwurst” that could be “adulterated with L. monocytogenes.”
Boar’s Head deli meat recalled product information
“On July 30, Boar’s Head expanded their July 26 recall to include all deli products, including prepackaged deli products, in shelf life from this establishment,” the CDC stated previously. “Look for “EST. 12612” or “P-12612″ inside the USDA mark of inspection on the product labels.”
The items “include meat intended for slicing at retail delis as well as some packaged meat and poultry products sold at retail locations,” FSIS stated Wednesday. “These products have ‘sell by’ dates ranging from 29-JUL-2024 through 17-OCT-24.”
Click here for the full list of product details with item numbers, brand names and sell by dates.
The ready-to-eat liverwurst products were produced between June 11, 2024, and July 17, 2024, and have a 44-day shelf life.
Recalled liverwurst products include 3.5-pound loaves in plastic casing, or “various weight packages sliced in retail delis,” according to the FSIS, and are labeled “Boar’s Head Strassburger Brand Liverwurst MADE IN VIRGINIA.”
The products, which the FSIS said were shipped to retailers, bear sell by dates ranging from July 25 to Aug. 30, 2024. Sell by dates are printed on the side of the packaging.
Additional ready-to-eat deli meats subject to recall
9.5-pound and 4.5-pound full product, or various weight packages sliced in retail delis, containing “Boar’s Head VIRGINIA HAM OLD FASHIONED HAM” with sell by date “AUG 10” on the product packaging.
4-pound, or various weight packages sliced in retail delis, containing “Boar’s Head ITALIAN CAPPY STYLE HAM” with sell by date “AUG 10” on the product packaging.
6-pound, or various weight packages sliced in retail delis, containing “Boar’s Head EXTRA HOT ITALIAN CAPPY STYLE HAM” with sell by date “AUG 10” on the product packaging.
4-pound, or various weight packages sliced in retail delis, containing “Boar’s Head BOLOGNA” with sell by date “AUG 10” on the product packaging.
2.5-pound, or various weight packages sliced in retail delis, containing “Boar’s Head BEEF SALAMI” with sell by date “AUG 10” on the product packaging.
5.5-pound, or various weight packages sliced in retail delis, containing “Boar’s Head STEAKHOUSE ROASTED BACON HEAT & EAT” with sell by date “AUG 15” on the product packaging.
3-pound, or various weight packages sliced in retail delis, containing “Boar’s Head GARLIC BOLOGNA” with sell by date “AUG 10” on the product packaging.
3-pound, or various weight packages sliced in retail delis, containing “Boar’s Head BEEF BOLOGNA” with sell by date “AUG 10” on the product packaging.
The recalled products bear establishment number “EST. 12612” inside the USDA mark of inspection on the product labels.
The above products were produced on June 27, 2024, according to Boar’s Head.
What prompted the Boar’s Head recall
According to the USDA, the problem was discovered when the FSIS “was notified that a sample collected by the Maryland Department of Health tested positive for L. monocytogenes.”
“The Maryland Department of Health, in collaboration with the Baltimore City Health Department, collected an unopened liverwurst product from a retail store for testing as part of an outbreak investigation of L. monocytogenes infections,” the agency stated previously. “Further testing is ongoing to determine if the product sample is related to the outbreak. Anyone concerned about illness should contact a healthcare provider.”
Details of listeria outbreak linked to deli meats
The FSIS is currently working with the CDC as well as state public health partners to investigate a multi-state outbreak of listeria infections linked to meats sliced at delis, USDA officials said.
According to the CDC, “All 43 people have been hospitalized and three deaths have now been reported, one from Illinois, one from New Jersey, and, as of this update, one from Virginia.”
As of Aug. 8, states involved in the outbreak included Minnesota, Wisconsin, Illinois, Indiana, Missouri, Georgia, North Carolina, Virginia, Maryland, Pennsylvania, New Jersey, New York and Massachusetts.
“Samples were collected from sick people from May 29, 2024, to July 12, 2024,” the USDA stated, adding that “the investigation is ongoing.”
In a notice published July 19, the CDC stated that many of those sickened in the outbreak had reported eating meat that they had sliced at deli counters.
“Investigators are collecting information to determine the specific products that may be contaminated,” the CDC stated.
“Listeria spreads easily among deli equipment, surfaces, hands and food,” the agency added. “Refrigeration does not kill Listeria, but reheating to a high enough temperature before eating will kill any germs that may be on these meats.”
Symptoms, side effects of listeria
According to the CDC, 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.
“If you are pregnant, it can cause pregnancy loss, premature birth, or a life-threatening infection in your newborn,” the CDC states on its website. “Other people can be infected with Listeria, but they rarely become seriously ill.”
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.
An estimated 1,600 people get listeria food poisoning each year and about 260 die, according to the CDC.
An earlier version of this story was originally published July 26, 2024.
(NEW YORK) — The catalyst for drinking less, or not at all, is unique for each individual but can range from physical health reasons to mental clarity. But whatever the motivation, the ‘sober curious’ movement is becoming more mainstream, especially among young adults.
The topic and trend was recently highlighted on the newest season of Emily in Paris, in which the title character explains that mostly Gen Z and millennials who adopt a wellness approach to their relationship with alcohol, though perhaps not fully sober, have started to explore not drinking.
“You might not be 100% sober, but you are interested in drinking less,” Hilary Sheinbaum, author of the Going Dry workbook and guide to drinking less, told Good Morning America.
A study published by the Journal of the American Medical Association in 2020 found that alcohol abstinence is becoming increasingly common among Gen Z, with 28% of college students reporting in 2018 that they did not drink alcohol, compared to 20% of respondents in 2002.
Alcohol-free alternatives have become even more accessible in recent years, as GMA first reported in 2022 as we emerged from the pandemic and the market was booming with new options, from nonalcoholic spiritless retail shops to more accommodating high-quality booze-free options outside of the traditional sugary mocktails.
“There are nonalcoholic beers, wines, and [non-alcoholic] spirits on restaurant and bar menus, even at hotels and resorts, and now in airplanes and even airline lounges. They are everywhere,” Sheinbaum said.
One Dallas-based content creator, Avon Nguyen, told GMA that cutting back on alcohol has also helped her financially.
“If I’m going to choose between drinking a $22 drink or paying rent, I’m probably gonna pay rent,” she explained.
Fitness influencer Kendall Toole, a former Peloton instructor turned podcast host, told GMA she’s seen positive improvements in her physical and mental health since she departed from drinking.
“The most notable shifts that I’ve seen on my health were one, the ability to get deep, restful sleep – [and two], my anxiety was not as profound and as adamant as it was previous.”
Unlike celebrities or athletes bottling tequilas, whiskey or other booze, Toole – who’s been open about her passion for wellness and mental health – opted to plant her flag in a clean energy and protein beverage, Don’t Quit, that better reflects her own journey and values.
For others looking to switch up what they sip and start dipping their toe into the sober curious journey, Sheinbaum emphasized how easy it is to do at home.
“One household item that is easy to mix with for a mocktail is orange juice,” she said. “You can make non-alcoholic mimosas with orange juice and non-alcoholic sparkling wine. It’s as easy as that.”
Check out these bartender-approved recipes to make more delicious, spirit-free sips for your next night in or sober soiree.
(NEW YORK) — The spread of a newer strain of mpox in Africa led the World Health Organization (WHO) to declare the disease a public health emergency of international concern (PHEIC) on Wednesday.
This newer strain is believed to be behind an outbreak in the Democratic Republic of the Congo (DRC) with more than 14,000 cases — mostly among children — and more than 500 deaths, and has been detected in neighboring countries that had never reported countries of mpox before.
On Thursday, Sweden became the first nation outside of the African continent to report a case of the newer strain of mpox, according to the country’s public health agency.
Cases of other strains, or clades, of mpox have popped up in other countries. In the U.S., there are more than 1,600 cases reported this year so far, more than twice the number seen at this time last year but not as many as seen during the outbreak in 2022-23.
“It’s clear that a coordinated international response is essential to stop these outbreaks and save lives,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus during a media briefing on Wednesday.
Experts told ABC News that by declaring a PHEIC, the WHO can help more countries collaborate by sharing data, allocating resources and helping make vaccines more readily available.
What is a PHEIC?
A PHEIC is defined as “an extraordinary event which is determined to constitute a public health risk to other States through the international spread of disease and to potentially require a coordinated international response,” by the International Health Regulations.
To be considered a PHEIC, the condition is considered, serious, sudden, unusual or unexpected; has implications for public health beyond where the place it originates; and has the potential to require immediate international action, according to the WHO.
“This is really [the WHO’s] highest level of alert,” Thomas Duszynski, director of epidemiology education at Indiana University’s Fairbanks School of Public Health, told ABC News.
“This means that this particular virus, or the mpox virus, and the illnesses that it causes, has reached a level that is now at a much higher rate than it should be, than when we see like in a normal year, as well as it’s starting to spill outside of the country of the Democratic Republic of Congo, which means that we have to get our arms around it and try and contain it,” he said.
A PHEIC was last declared for mpox during the outbreak in 2022-23, but this current outbreak is different because it involves a clade called clade Ib that seems to spread more quickly and has a higher mortality rate, Duszynski said.
What becomes available when a PHEIC is declared?
Emily Smith, an associate professor in the Department of Global Health at George Washington University’s Milken Institute School of Public Health, said declaring a PHEIC can help galvanize collaboration and mobilize resources.
“Collaboration can be really important in terms of sharing data from different surveillance systems or even things like genomic sequences, so we can understand how different cases are related to each other,” she told ABC News.
On the mobilizing resources front, Tedros said during the media briefing on Wednesday that WHO had released $1.5 million in contingency funds and planned to release more soon. The WHO’s regional response plan — including support surveillance and preparedness and response activities — will cost $15 million.
Additionally, last week, the WHO triggered the process to begin allowing mpox vaccines to go through the process for emergency use listing, similar to what was seen with the COVID-19 vaccine during the pandemic.
The PHEIC will also allow vaccines to be sent to other affected countries more quickly than they might have been without an emergency declaration, Duszynski said.
“In the Democratic Republic of Congo, their access to the impact vaccine is limited,” he said. “So, for example, the U.S. has dedicated 50,000 doses of that vaccine for the Democratic Republic of Congo, so that that’s part of that cooperation of not only sending, knowledge and science and research, but also aid, in the sense of vaccines.”
“We could also send personnel, such as epidemiologists, to help with the investigation and to help identify those who are ill and put some isolation and quarantine around those individuals to keep this virus from spreading,” Duszynski added.
What should the public do?
The experts said the best thing to do is to get vaccinated if you are a high-risk individual.
Currently, the JYNNEOS vaccine, a two-dose vaccine approved by the Food and Drug Administration to prevent smallpox and mpox, is the only vaccine being used in the United States to prevent mpox. Data from Africa has shown two doses of JYNNEOS are at least 85% effective in preventing mpox infection.
High-risk individuals include those who are immunocompromised, suffer from chronic diseases, or have a history of eczema, which causes breaks in the skin and can lead to mpox transmission.
Smith said other high-risk individuals include gay, bisexual or men who have sex with men — a group that was most affected during the 2022-23 outbreak — should get vaccinated.
She said that anyone who has only received their first dose should be sure to get their second dose.
“Just be aware if you or anyone you know, or your family, experiences lesions, skin lesions or genital lesions,” Smith added. “[You] definitely want to contact your doctor. We do have treatment options available in the U.S.”
Both Smith and Duszynski reiterated the Centers for Disease Control and Prevention’s warning that the general public is at low risk from the type of mpox circulating in the DRC.