FDA approves Eli Lilly’s obesity medication for obstructive sleep apnea
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(NEW YORK) — The FDA has expanded the approval of Eli Lilly’s obesity medication Zepbound to include treating moderate to severe obstructive sleep apnea for people with obesity — the first medication approved for the condition.
The new, expanded Zepbound approval means that insurance providers, including Medicare, will likely cover the medication for people with sleep apnea and obesity. Some insurance providers, including Medicare, do not offer reimbursement to treat obesity alone.
The new approval is for people with moderate to severe obstructive sleep apnea who are also living with obesity. Eli Lilly estimates that is about 15-20 million adults in the U.S.
Obstructive sleep apnea isn’t just an inconvenience, it’s a serious medical condition that impairs breathing and sleep quality. Obesity and obstructive sleep apnea are linked. People tend to see their obstructive sleep apnea get better when they lose a significant amount of weight. It’s likely the weight loss associated with the medication is helping improve the sleep apnea.
Right now, there is no medicine to treat obstructive sleep apnea — it’s only treated with a positive airway pressure device.
In a study, people who took Zepbound had at least 25 fewer breathing interruptions per hour while they slept. They also lost an average of 20% of their body weight.
The study also followed people over a year, and found that up to half of the adults taking Zepbound no longer had obstructive sleep apnea symptoms at the end of the year.
Obstructive sleep apnea is more common in men than women. Up to 34% of U.S. men have OSA compared to 17% of U.S. women, according to the American Academy of Family Physicians.
Common signs of sleep apnea include heavy snoring at night, long pauses in breathing while sleeping as well as excessive daytime sleepiness, forgetfulness and morning headaches. The symptoms of the disorder can lead to significant medical problems.
Henry Callander says his forehead blew up like “a giant bee sting” after a Botox treatment. Via ABC News.
(NEW YORK) — JGL Aesthetics’ Instagram profile promised its clients radiant skin, friendly service and a machine they said could give people toned abs. However, some clients allege that the New York medical spa’s owner injected them with fake Botox that caused negative side effects.
Aesthetician Joey Luther was arrested last Wednesday for allegedly buying counterfeit Botox from China and injecting it into patients, without the required New York medical license, according to the U.S. Attorney’s Office in the Southern District of New York.
The 54-year-old was charged with wire fraud, smuggling and other crimes related to the purchase and import of misbranded and counterfeit drugs at the Manhattan spa. None of the counterfeit Botox was approved by the Food and Drug Administration, prosecutors said.
According to the criminal complaint, an investigation began after one of Luther’s patients said they experienced double vision, heart palpitations, weakness from the waist up and other problems after receiving a Botox injection from JGL Aesthetics.
One alleged victim visited three hospitals to treat her symptoms and was diagnosed with Botulism — a potentially fatal illness — in March 2024, prosecutors said.
Almost 5 million people in the U.S. got Botox in 2023, according to the American Society of Plastic Surgeons.
“So I think I saw the biggest uptick in requests for Botox during the pandemic,” Dr. Evan Rieder, a dermatologist, told “Nightline.” “When we were sitting at home during the pandemic, people were really glued to their cellphones and they were really diving into social media.”
Prosecutors say that Luther didn’t have the required New York State medical license to administer Botox.
When one client in the criminal complaint allegedly texted Luther about her symptoms, the complaint claims that “Luther falsely responded that he injected Botox from Allergan,” the name brand.
“If you’re getting something that’s actually not Botox, no one knows what is actually going into that mixture,” Rieder said. “If you have Botox that’s counterfeit, but it’s too strong, you could get Botulism, and it can cause all sorts of side effects in your body where the nerves are being paralyzed.”
The complaint alleges that Luther responded to multiple clients’ concerns, reassuring them about alleged symptoms including worsening vision, difficulty swallowing, headaches and neck fatigue.
While Luther was messaging his clients, the complaint alleges that he was in contact with his supplier to inform them that the product he got from them was tainted.
According to the complaint, “he, in fact, tries to bargain with his supplier, suggesting that, if they want to keep him as a client, that they need to send better product and send it quickly,” trial attorney and ABC News contributor Brian Buckmire said.
Henry Callander was among Luther’s patients, but isn’t part of the criminal complaint. His friends recommended JGL Aesthetics, and he thought he was getting his forehead treated for a fraction of the price.
“It was probably like 20% cheaper than regular Botox,” Callander told ABC News. “Depending on the treatment I was doing, it was probably like $400 a treatment.”
An attorney representing Luther did not respond to a request for comment from “Nightline.”
Luther is out on bail, but could face decades in prison if the complaint leads to trial and he’s found guilty. His next court date is Feb. 12.
The alleged danger isn’t limited to New York — the CDC issued a notice about counterfeit Botox and injections from individuals who were not following state or local requirements in December after 17 people across nine states suffered negative reactions.
In California, Lori Reed said she got Botox and filler treatments from a woman who she thought was a nurse for a few years because the price was right. Eventually, she alleged she had a bad reaction.
“My eyes were swollen and they were beet red,” she told “Nightline.” “And it has not gone away to this day.”
Several years later, Reed said she is still dealing with the consequences, even after getting multiple procedures to reverse the damage.
“For a while, I was very self-conscious. I wouldn’t even date,” she told “Nightline.” “I felt like I looked like a monster.”
According to a civil complaint filed by 16 different women, the injector was never licensed to inject Botox. The suit has since been settled.
She was ultimately found guilty in a criminal case and is serving probation after her six-year prison sentence was suspended.
“I wanted her to reap some sort of consequences for the damage that she had done — I expected her to do jail time,” Reed said. “It turned out that she did not. So I was a little disappointed in that.”
A “Nightline” episode that aired on ABC on Jan. 28, and is available now on Hulu, details the allegations about counterfeit Botox that led to criminal charges.
(LOS ANGELES) — The percentage of emergency department (ED) visits related to fire and smoke inhalation rose dramatically in the days immediately after the Los Angeles wildfires last month, new data published Thursday shows.
The wildfires broke out in the Pacific Palisades and in Eaton Canyon on Jan. 7. Although several destructive wildfires emerged, the Palisades Fire and the Eaton Fire caused the most damage.
Fueled by strong winds and dry weather, the fires burned more than 57,000 acres, destroyed about 16,000 structures, and killed at least 29 people, according to the California Department of Forestry and Fire Protection.
A team from the Los Angeles County Department of Public Health and the Centers for Disease Control and Prevention reviewed data from the county’s Syndromic Surveillance program, which receives and analyzes real-time data from most county EDs.
By collecting this data, the program can detect early warning signals of a potential public health threat that requires a response and alert health care professionals, according to the department of health.
ED visits, referred to in the report as “encounters,” were classified as being wildfire-associated if fire or smoke inhalation–related terms were listed in the chief complaints or the diagnoses sections.
The team looked at three periods: a three-week period before the wildfires began, the first six days of the wildfires and the week after the wildfires began.
Data showed the average percentage of ED visits associated with the wildfires increased eightfold from 0.06% to 0.52% in the six days after the wildfires. The peak was seen on Jan. 8, with 1.01% of all ED visits related to the wildfires. During the week after the wildfires began, ED visits decreased but still remained elevated at 0.2% compared to baseline.
The average percentage of ED visits was found to be linked to an increase in the average daily Air Quality Index (AQI), which is put out by the Environmental Protection Agency.
Average daily AQI rose from 75, which is classified as “moderate level of concern” to an average of 110, classified as “unhealthy for sensitive groups,” in the six days after the wildfires began. In the week following the outbreak of the fires, average daily AQI returned to “moderate” at 58.
The report found a small increase in the average percentage of burn-related injuries and eye-related injuries but there were no increases seen in the percentage of visits related to asthma or cardiovascular reasons.
In contrast, the report found that immediately after the wildfires began, all-cause ED encounters — meaning visits to the department for any reason — decreased by 9%.
The authors stated that the decrease could for multiple reasons, with some including school closures, business closures, displacements, challenges accessing health care, residents seeking care in clinics or urgent care centers, or residents visiting EDs in neighboring counties.
“Near real-time surveillance of health outcomes during and after wildfires can estimate effects on health care use, serve as an early warning for acute health impacts, and identify opportunities for intervention,” the authors wrote. “Further analyses are planned to identify which illnesses have most affected specific populations.”
(MARIN COUNTY, Calif.) — Health officials in Marin County, California say a child with a suspected bird flu infection drank raw milk before getting sick.
“[Marin County Public Health] is reporting a suspected case of bird flu in a child who experienced fever and vomiting after drinking raw milk,” according to a statement. “The child has recovered, and no other family members became sick, indicating no person-to person transmission.”
“MCPH is actively investigating this possible case of bird flu linked to raw milk consumption with the California Department of Public Health (CDPH) and the federal Centers for Disease Control and Prevention (CDC),” the statement continued, further noting that “raw milk, which hasn’t been pasteurized, poses a risk of spreading diseases, including influenza.”
For now, the child is only suspected of having bird flu, pending tests to confirm the diagnosis. However, officials are concerned about the risks of drinking raw milk in an ongoing bird flu outbreak in the state, with 32 human cases confirmed in the state so far, all but one of which officials say originated from exposure to cattle.
California health officials last week announced that it had “secured a broad, voluntary recall” of raw milk and cream products from supplier Raw Farm, LLC after it tested positive for the virus “at both retail and dairy storage and bottling sites.”
It’s not yet clear whether people can become infected with bird flu from drinking raw milk, but studies in cats and mice suggest the animals can get sick from drinking contaminated raw milk.
The CDC continues to warn against drinking raw milk, which can contain bacteria and viruses that can lead to gastrointestinal distress. In rare cases, it can lead to more severe illness such as Guillain-Barre syndrome, which can cause paralysis.
There have been at least 58 human cases of bird flu so far this year in the U.S., according to the CDC, almost all of which have been farm workers exposed to infected livestock.
