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  • Energy Drinks Linked to Poor Sleep Quality, Insomnia Among College Students

    Original Article | Chelsie Derman

    Male college students were found to consume more energy drinks than female college students, and they had a greater risk for a short sleep duration due to energy drink consumption.

    College students may consume energy drinks to stay alert, but the beverage may make people sleepier—a new study found energy drinks are linked to poor sleep quality and insomnia among college students.1,2

    “Even small amounts of [energy drinks] had an impact on sleep where daily [energy drinks] consumption increased the risk of sleep problems across all parameters for both sexes,” wrote the investigators.

    A study, led by Siri Kaldenbach, from the Innlandet Hospital Trust, in Lillehammer, Norway and the department of clinical medicine at the University of Oslo in Oslo, Norway, sought to investigate the frequency of energy drink consumption and the association between energy drink consumption and sleep characteristics in Norwegian college and university students. They also evaluated whether males or females consumed more energy drinks and how energy drinks affected their quality of sleep.

    The investigators conducted a cross-sectional study and obtained data from the Students’ Health and Wellbeing Study 2022 (SHOT2022), a national survey. The survey, comprised of mental health and lifestyle questions, was distributed electronically between February 8 – April 19, 2022, to full-time Norwegian students. The study included 53,266 students enrolled in higher education in Norway, aged 18 – 35 years (mean age: 24 years) with 66.4% women.

    The survey evaluated energy drink consumption, with the option of daily, 4-6 times a week, 2-3 times a week, 1 time per week, 1-3 times per month, and seldom/never. The survey also assessed sleep-related questions, and students reported usual bedtime and bed-rise time. The investigators evaluated sleep onset latency and wake after sleep onset.

    Of the participants, 4.7% of men and 3.3% of women reported consuming energy drinks daily. Moreover, men were associated with consuming more energy drinks than women. Women (49.6%) were more likely than men (39.6%) to never or seldom consumed energy drinks.

    Additionally, 5.5% of women reported consuming energy drinks 4 -6 times a week and 3.3% consumed them daily. In contrast, 7.8% of men consumed energy drinks 4-6 times a week with 4.7% consuming the drinks daily.

    Kaldenbach and colleagues observed a larger frequency of energy drink consumption was linked to sleep pattern issues such as sleep onset latency and wake-after-sleep onset. The strongest association was observed between daily energy drink consumption and short sleep duration, with men (risk ratio [RR], 2.07; 95% CI 1.77 – 2.42) exhibiting a greater risk of short sleep duration than women (RR, 1.87; 95% CI 1.64 – 2.14).

    Investigators called attention to an association between energy drink consumption and insomnia. Among women, insomnia was present among 51% reporting energy drink consumption compared to 33% among those who never or seldom consumed energy drinks. Among men, insomnia was present among 37% reporting energy drink consumption compared to 22% among those who never or seldom consumed energy drinks.

    “Most of the associations between [energy drinks] and sleep were similar for male and female students but with a few notable exceptions,” investigators wrote. “For bedtime and risetime, we observed a significantly stronger effect for men compared with women.”

    Because of the observational design, the investigators stated they could not infer causality. Moreover, the team said did not know what time the energy drink was consumed or the specific amount of the beverage—they only had access to the frequency of energy drink consumption—so that could have affected results. Another limitation, as pointed out by the team, was the “modest response rate” of 35.1% and limited information about the participants who did not complete the survey other than their age and sex.

    “The results from the current study show that there is a robust association between the frequency of [energy drinks] consumption and the different sleep parameters,” investigators wrote. “Identifying modifiable risk factors for sleep problems among college and university students is vital and our results suggest that the frequency of [energy drinks] consumption could be a possible target for interventions.”

    References

    1. Kaldenbach S, Hysing M, Strand TA, et al. Energy drink consumption and sleep parameters in college and university students: a national cross-sectional study. BMJ Open 2024;14:e072951. doi:10.1136/ bmjopen-2023-072951
    2. Energy Drinks Linked to Poor Sleep Quality And Insomnia Among College Students. EurekAlert! 2024. https://www.eurekalert.org/news-releases/1031709?. Accessed January 22, 2024.
  • Philips Suspends U.S. Sales of Breathing Machines After Recall

    Original Post | New York Times

    Under a settlement with regulators, the company must revamp some operations before resuming sales of its CPAP and ventilator devices in the United States.

    Philips Respironics announced on Monday that it would halt sales of all of its breathing machines in the United States after reaching a settlement with the Food and Drug Administration over continuing problems with the devices.

    Millions of the company’s ventilators and CPAP machines, used to ease breathing at night, were recalled after reports that they blew bits of foam and potentially toxic gases into consumers’ airways.

    Under the settlement, Philips said it would have to meet a list of standards in a “multiyear” plan before it could resume business in the United States. The company said further details would be disclosed when the agreement was finalized in court. But it added that it would continue to repair existing devices and provide service for people using them.

    The company initially began the recall of millions of devices in June 2021 and paused sales of new sleep therapy machines to the United States, according to Steve Klink, a spokesman for Philips. At the time, the company and the F.D.A. cited the potential for serious injury or permanent impairment from the potentially cancer-causing chemicals emitted from the devices.

    The company has since released results of additional testing, saying the devices were “not expected to result in appreciable harm to health in patients,” and it said it was continuing to conduct tests. The F.D.A. has pushed back on some of the company’s updated claims, and at one point called them “unpersuasive.” Philips has also faced continuing scrutiny and undertaken more recalls in its attempts to upgrade the devices.

    Dr. Jeff Shuren, director of the F.D.A.’s device division, said the agency could not comment until the agreement was finalized and filed with the court.

    The initial recall affected about 15 million breathing machines produced since 2006, though roughly five million were still in circulation in mid-2021.

    With replacements not immediately available, the recall caused confusion and upset for many doctors and patients. Many struggled to weigh the risk of continuing to use a faulty device against the peril of sleeping with impaired breathing.

    Millions of people suffer from sleep apnea, or interrupted breathing, which is associated with elevated rates of strokes, heart attacks and possible cognitive decline. Recalled machines included CPAP, or continuous positive airway pressure, machines; BiPap devices; and ventilators.

    Philips, which is based in Amsterdam, disclosed that it had reached an agreement, or a consent decree, that was brokered with the U.S. Justice Department and the F.D.A., along with the announcement of its fourth-quarter earnings. The company said it wrote down about 363 million euros related to the cost of completing the settlement requirements. Its stock, which trades in the United States, was down about 7 percent Monday morning.

    The company said it would continue to sell its products in other countries.

    Thousands of patients have since sued Philips, claiming that the machines led to a wide range of respiratory and other ailments, including allegations of deaths from lung cancer. In September, the company reached a $479 million settlement with plaintiffs that was meant to cover the financial losses related to repairing or replacing the machines. Litigation over illnesses and medical costs is still pending.

    Christina Jewett covers the Food and Drug Administration. She is an award-winning investigative journalist and has a strong interest in how the work of the F.D.A. affects the people who use regulated products. More about Christina Jewett

  • Dangers of Uncontrolled Sleep Apnea

    Original Article | JohnsHopkins.org

    You’ve probably heard that regular exercise and a heart-healthy diet are the most important things you can do for your cardiovascular health. As it turns out, though, the quality of sleep you receive is also critical to your heart’s wellbeing. 

    In particular, undiagnosed sleep apnea is directly tied to an increased risk in cardiovascular and metabolic health. The scariest part? You might not even know you have this very common problem.

    “Sleep apnea happens when upper airway muscles relax during sleep and pinch off the airway, which prevents you from getting enough air. Your breathing may pause for 10 seconds or more at a time, until your reflexes kick in and you start breathing again,” explains Jonathan Jun, M.D. , a pulmonary and sleep medicine specialist at the Johns Hopkins Sleep Disorders Center.

    Sleep apnea occurs in about 3 percent of normal weight individuals but affects over 20 percent of obese people, Jun says. In general, sleep apnea affects men more than women. However, sleep apnea rates increase sharply in women after menopause. Sleep apnea is often linked to heart disease and metabolic issues like diabetes.

    What are the signs of sleep apnea?

    There are two kinds of sleep apnea: obstructive sleep apnea and central sleep apnea. Obstructive sleep apnea happens when air can’t flow into or out of the nose or mouth, although you’re trying to breathe. Central sleep apnea happens when the brain fails to send the right signals to your muscles to make you start breathing. (This type is less common.)

    “Sleep apnea may be noticed more by the bed partner than by the sleeper,” says Jun. “Your bed partner might notice that your breathing pauses, or they may complain of your loud snoring.”

    That said, snoring itself—though annoying—isn’t the same as sleep apnea. Snoring is just the vibration sound created by airway resistance. You can snore loudly and not have sleep apnea, and you may even have sleep apnea without much snoring.

    People with sleep apnea might also suffer from unexplained fatigue and mood swings, because their breathing interruptions continually wake them and prevent them from settling into a deep, nourishing sleep.

    The consequences can be significant, Jun says. “We’re talking about car accidents in the daytime, lost productivity at work, mood swings, waking up feeling groggy and falling asleep in class.”

    Other sufferers might wake up with a dry mouth, since sleep apnea tends to make you breathe with an open mouth, drying out your saliva. Some awaken with a headache, which may be caused by low oxygen or high carbon dioxide levels during sleep.

    How is Weight Control Linked to Sleep Apnea?

    “Weight control is very important. There are many studies showing that losing weight can either completely cure you of sleep apnea or at least make it less severe,” Jun says.


    Sleep apnea, cardiovascular risk and metabolism

    Several studies have shown an association between sleep apnea and problems like type 2 diabetes strokes heart attacks and even a shortened lifespan, says Jun. Why this connection? For one thing, obesity is common in sleep apnea patients, and obesity greatly increases risks of diabetes, stroke and heart attack, he says. “In most cases, obesity is the main culprit behind both conditions,” Jun explains.

    Still, it’s important to note that not everyone with sleep apnea is obese. Furthermore, evidence suggests an independent link between sleep apnea and diabetes. “Our lab and others have shown that sleep apnea is associated with higher risks of diabetes, independent of obesity, and that sleep apnea can increase blood sugar levels,” says Jun.

    For people who are overweight or obese, weight loss is key for treating or avoiding sleep apnea. People who accumulate fat in the neck, tongue and upper belly are especially vulnerable to getting sleep apnea. This weight reduces the diameter of the throat and pushes against the lungs, contributing to airway collapse during sleep.

    Women in particular should be careful as they age. While premenopausal women tend to put on weight in the hips and in the lower body instead of the belly, this shifts with time. Weight begins to accumulate in traditionally “male” areas like the tummy, and this leads to a greater chance of sleep apnea.

    “After menopause, hormones change and women tend to start looking like men in terms of where the weight gets put on. It’s a time to be paying attention to the risks of sleep apnea because women begin to catch up to men in the rates of apnea after menopause,” Jun says.15

    Diagnosing and treating sleep apnea for better health

    It’s important to treat sleep apnea, because it can have long-term consequences for your health. While there have been some high-profile deaths linked to sleep apnea—such as with Judge Antonin Scalia —Jun says that the true risk is from damage done over time.

    Obstructive sleep apnea can range from mild to severe, based on a measurement system called the apnea-hypopnea index (AHI). The AHI measures the number of breathing pauses that you experience per hour that you sleep.

    Obstructive sleep apnea is classified by severity:

    • Severe obstructive sleep apnea means that your AHI is greater than 30 (more than 30 episodes per hour)
    • Moderate obstructive sleep apnea means that your AHI is between 15 and 30
    • Mild obstructive sleep apnea means that your AHI is between 5 and 15

    Whether or not you need treatment for sleep apnea depends on its severity, whether or not you have symptoms such as sleepiness and other health conditions. For example, if you have risk factors for heart disease, your doctor might opt to treat you even for mild sleep apnea. On the other hand, if you have a severe case of sleep apnea, your doctor might insist on treatment even if you’re not sleepy.

    The main choice of therapy is a breathing device called a CPAP, or continuous positive airway pressure machine. A CPAP machine pipes humidified air through the nose, which creates air pressure to keep your throat open while asleep. This prevents pauses in breathing.

    “CPAP is the first-line treatment, and it’s very effective,” Jun says. A recent Johns Hopkins study looked at what happens to metabolism at night when sleep apnea patients don’t wear their CPAP. The study found that the resulting apnea caused a spike in blood sugar, heart rate, blood pressure and stress hormones—a response similar to what might happen if you were asked to get up in front of a crowd to speak. “It’s very similar to that type of a stress response,” says Jun. “I would liken sleep apnea to something like that happening on a nightly basis.”

    CPAP is not the only alternative.

    Many cannot tolerate the CPAP machine and are able to obtain the help they need from a Sleep Apnea Dental Specialist. Their use of an oral appliance has helped hundreds of thousands resolve their medical issues as they pertain to Sleep Apnea.

    Get the Medical Equipment You Need at Home

    Many studies show that regular use of CPAP or oral devices reduces blood pressure and improves wakefulness during the day. People with sleep apnea who use sleep apnea therapeutic devices also report improved quality of life. In some observational studies that compare people with apnea who seek sleep apnea remedies versus those who don’t, those seeking treatment have lower risk of stroke and heart attack and lower blood glucose, Jun notes.

    If you or your partner has noticed signs of sleep apnea, visit your doctor. A sleep specialist can order a sleep apnea test, which uses equipment to monitor your breathing and oxygen levels while you sleep. Often, you’ll visit a laboratory to spend the night for monitoring. Other times, it’s possible to use a portable, take-home kit. You’ll rest easier knowing the results.

  • Sleeping five hours or less increases risk of chronic illnesses, study warns

    Original Article | By Judy Packer-Tursman

    Getting a good night's sleep of more than five hours can help older people avoid developing multiple chronic illnesses, a new study suggests. Photo by Wokandapix/Pixabay

    Getting a good night’s sleep of more than five hours can help older people avoid developing multiple chronic illnesses, a new study suggests. Photo by Wokandapix/Pixabay

    Oct. 18 (UPI) — Older people who get five hours of sleep a night or less may face a far greater risk of developing two or more chronic illnesses, such as heart disease, cancer or diabetes, compared to people who sleep longer, a new study suggests.

    The research, published Tuesday in the journal PLOS Medicine, tracked the impact of sleep duration on the health of more than 7,000 men and women at the ages of 50, 60 and 70.

    This was done via a 25-year follow up of participants in the Whitehall II cohort study involving members of the British civil service.

    The British and French researchers, led by University College London, found that sleeping for five hours or less at the ages of 50, 60, and 70 was linked to a 30% to 40% increased risk of developing multiple chronic diseases versus people who slept for up to seven hours.

    The investigators also examined the relationship between each participant’s length of nightly sleep and mortality. They found that nightly sleep that lasted five hours or less at age 50 was associated with a 25% increased risk of death over the 25 years of follow-up.

    This is primarily because short sleep duration increases the risk of chronic illness that in turn increases the risk of death, the release said.

    The scientists also analyzed whether sleeping for nine hours or more affected health outcomes, but they found no clear link between this sleep duration and developing chronic diseases for healthy people at age 50.

    RELATED Getting enough sleep key to a healthy immune system

    However, for those individuals already diagnosed with a chronic condition, such long sleep was associated with roughly a 35% increased risk of developing another illness, possibly due to underlying health conditions affecting sleep, they said.

    “As people get older, their sleep habits and sleep structure change. However, it is recommended to sleep for seven to eight hours a night — as sleep durations above or below this have previously been associated with individual chronic diseases,” Séverine Sabia, the study’s lead author said in the release.

    A researcher/epidemiologist at University College London’s Institute of Epidemiology & Health and at Inserm, Université Paris Cité, Sabia advised having good sleep hygiene, such as ensuring the bedroom is quiet, dark and a comfortable temperature before going to bed.

    RELATED Going to bed too early or sleeping too much can increase dementia risk, study says

    She also suggested avoiding large meals before bedtime.

    The study used self-reported data on sleep, which the researchers noted is likely to be subject to reporting bias.

    Sponsors of the research included the National Institute on Aging, a part of the National Institutes of Health, the U.K. Medical Research Council and the British Heart Foundation.

  • Sleep Apnea. Bad for Your Brain.


    Original Article | BottomLine INC
    Chris Iliades, MD is a regular contributor to Bottom Line Health. He was an ear, nose, throat, head, and neck surgeon before becoming a full-time medical writer.

    According to the American Heart Association and the American Academy of Neurology, obstructive sleep apnea (OSA) is bad for brain health. Studies show that OSA causes cognitive impairment, which is the loss of your brain’s ability to remember, think, concentrate, learn, and make decisions.

    Sleep Apnea

    What happens during OSA?

    In people with OSA, the oral or nasal airway collapses during sleep and breathing stops for a short period. This is called apnea. Blood oxygen levels decrease and carbon dioxide levels increase. Rising carbon dioxide triggers your brain to wake you up enough to breathe. Almost everyone with OSA snores, usually loudly, so a sleeping partner may hear loud snoring followed by quiet, and then sudden gasping for air. In mild-to-moderate OSA, there may be between five and 30 episodes per hour. In severe OSA, these instances can occur more than 30 times per hour.

    A 2021 study reported at the American Academy of Neurology annual meeting showed that people with OSA were 60 percent more likely to score in a lower range on cognitive testing than people without it. The worse the OSA, the worse the cognitive decline. The average age of study participants was about 70.

    Further, OSA increases the risk of heart attack, stroke, heart arrhythmia, high blood pressure, and type 2 diabetes.

    Are you at risk?

    The American Heart Association estimates that OSA may affect close to 40 percent of U.S. adults and up to 80 percent of people with cardiovascular disease. It is more common in men and in people who are overweight. You could be at higher risk if you have a family history of OSA. Other risk factors include smoking, drinking alcohol, taking sleeping pills, and having any type of narrowing of the nasal or oral airway, like a deviated nasal septum or large tonsils or adenoids.

    Reduce risk, improve health

    Lowering risk can be as simple as exercising. An important study presented at the 2021 meeting of the American Heart Association showed that exercise reduces the risk of both OSA and cognitive decline.

    In the study, 47 patients with varying degrees of cognitive loss were tested for a cognition score. Half of the patients were given a six-month-long supervised exercise program. After six months, the exercise group had fewer OSA episodes, a 32 percent improvement in their cognitive scores, and better glucose metabolism in the brain.

    In addition to exercise, lifestyle changes that reduce the risk or improve symptoms of OSA include not drinking, not smoking, and losing weight. Sleeping on your side and propping up your upper body during sleep may also reduce OSA. In some cases, surgery can be used to correct a deviated septum or remove tonsils and adenoids if they are contributing to OSA.

    Diagnosis

    Mark Twain said, “There ain’t no way to know why a man can’t hear himself snore,” but there is a way to find out if you have sleep apnea. If your sleeping partner describes periods of snoring and apnea, or you wake up groggy with a headache and feel sleepy all day, you should have a sleep study.

    During the sleep study, you spend a night in a sleep lab, where specialists called polysomnographers document sleep apnea and grade the severity. Sleep study kits you can use at home are now available, so you may not need to spend the night sleeping in a laboratory.

    Treatment

    For mild sleep apnea, lifestyle changes, sleeping position, and sometimes an oral appliance that keeps your tongue from blocking your oral airway may be all you need. For more severe OSA, the treatment of choice is CPAP. During CPAP treatment, you wear a mask while you sleep that provides humidified oxygen through your nose to force open your airway. It is very effective but takes some getting used to, and you may need to experiment with different types of masks, levels of air pressure, and humidification devices to find the most comfortable option.

    A new technology called hypoglossal nerve stimulation may eliminate the need for CPAP for some people who can’t tolerate it. With this treatment, a pacemaker implanted in the chest stimulates the hypoglossal nerve to open the back of the throat.

    OSA is that it is both common and dangerous. If you have the symptoms, tell your doctor and get OSA under control now. Your brain and your sleeping partner will thank you.

  • CPAP Crisis Creates Chaos for Apnea Victims and Snorers!

    Original Article | The People’s Pharmacy

    Do you know someone who snores and/or stops breathing temporarily? They could have sleep apnea. Why is there a CPAP crisis? Who is at fault?

    According to the AMA“About 30 million people in the United States have sleep apnea, but only 6 million are diagnosed with the condition.” People with sleep apnea may stop breathing many times during the night. These episodes can last a few seconds or as long as a minute or two. They can occur dozens of times an hour. There is a CPAP crisis going on because many patients are having a hard time getting safe CPAP devices. Disclaimer: we do not know who made the CPAP device in the photo. The illustration is not intended as criticism.

    What’s It Like To Suffer Sleep Apnea?

    I have tried holding my breath while timing it with my smart phone stopwatch. It starts to get uncomfortable around 25 seconds and I have to take a breath around 30 seconds. I have a hard time imagining what it would be like to go longer than that.

    Obstructive sleep apnea (OSA) is caused by the collapse of muscles in the throat. This can block the airway. The result is reduced oxygenation of the circulating blood.

    Patients with OSA often suffer from daytime sleepiness and brain fog. That makes them more prone to accidents. They are also more likely to develop hypertension, strokes, irregular heart rhythms or heart attacks.

    Symptoms can include noisy snoring interrupted by gasping or gagging sounds. For a bed partner, this can be scary and/or annoying. It’s hard to sleep when the person nearby is “sawing wood” and intermittently gasping for air. People with OSA may also complain about frequent nighttime trips to the bathroom to pee, morning headaches, daytime irritability and “cotton mouth” upon awakening.

    Treating OSA and the CPAP Crisis:

    To treat sleep apnea, doctors prescribe machines that pump air in a continuous stream that can help keep the airways open. They are called CPAP devices, for continuous positive airway pressure. Some people find the devices noisy and uncomfortable. You have to wear a kind of face mask that pushes air into the throat and lungs.

    Others find the devices improve the quality of their lives. Here is just one of the hundreds of messages we have received on our website:

    Jerry reports that CPAP made a difference:

    “Sleep apnea is a medical condition that can cause frequent nighttime urination. After being diagnosed with severe obstructive sleep apnea, I was treated using CPAP therapy.

    “The very first night after getting my CPAP machine I slept for a full 7 hours. Before treatment, I was waking and passing large amounts of urine every 1-2 hours. My blood pressure went from high to normal, and my heart rate during exercise dropped by 20 heartbeats.”

    The CPAP Crisis Is Creating Chaos:

    Needless to say, people with serious sleep apnea rely on these machines and are well aware that their lives depend on them. Just imagine the panic they might feel if their machines were no longer available.

    That has happened to far too many patients over the last year, as the company that dominates the industry, Philips Respironics, fumbled a recall of faulty CPAP devices.

    Here is what one reader wrote us about the CPAP crisis:

    “My husband has sleep apnea, so he has used a CPAP for over 12 years. Recently his machine stopped working. When he contacted his supplier, he was told his machine had been recalled and he would have to wait for a replacement. They advised him to contact the manufacturer, Philips.

    “He called Philips, and after following the instructions to restart the machine, was told it was not working. That was July 11. We had just gotten home from the ER where we both tested positive for COVID and received infusions. So he has been without his CPAP since then.

    Anxiety interferes with sleep:

    “He is very aware of the dangers of not using the CPAP machine and has been sleeping very uncomfortably since then. I have been anxious as well, just listening to his snoring. Here’s hoping he does not stop breathing, as he used to do before getting the CPAP.

    “I have heard that it can take up to a year to get a replacement. Surely, he is not alone in this situation. What is a person with sleep apnea supposed to do? A person at his pulmonologist’s office said they are currently diagnosing new patients with severe sleep apnea. These patients are being placed on waiting lists.

    “To my mind, this situation is similar to not having baby formula available. Apparently, there are currently just two companies in the USA who manufacture CPAP devices. What can patients do without this important appliance? Doctors warn that using the machine every night is of critical importance. What can be done to help so many people in need?

    “I am hoping that sleep apnea patients can soon get the machines they desperately need for a good safe night’s sleep.”

    How Has the FDA Fumbled the CPAP Crisis?

    Our reader is right to compare the situation with CPAP machines to the baby formula shortage. Both result from the FDA’s inadequate oversight. In our opinion, the FDA has fumbled a few too many oversight responsibilities.

    That’s not just our opinion. An article in JAMA Internal Medicine, July 26, 2021 reviewed the FDA’s oversight of MAUDE (Manufacturer and User Facility Device Experience). The agency relies on device manufacturers, distributors, physicians, patients, hospitals and other health care facilities to submit reports of problems. Unfortunately, the FDA only pays attention to deaths, rather than all serious complaints.

    The analysis in JAMA Internal Medicine points out that:

    “For the overall sample, the percentage of reports with deaths that were not classified as deaths was 23%, suggesting that approximately 31,552 reports in our sample had deaths that were classified in other categories.”

    If the FDA ignores serious complaints and overlooks deaths with misleading codes, it risks leaving flawed medical devices on the market long past their “use by” date. You can read more about the agency’s fumbling and bumbling at this link.

    What Went Wrong With CPAP Machines”

    On July 29, 2021, the FDA issued an announcement about problems with Philips Respironics BiPap and CPAP machines.

    On May 19, 2022 the agency updated its warning:

    “Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device.”

    The Washington Post reported on July 29, 2022 that:

    “Today, those machines are at the heart of one of the biggest medical device debacles in decades.”

    “If inhaled or swallowed, the emissions could cause headaches, asthma, lung problems and even cancer, the company warned in launching a massive recall. The Food and Drug Administration classified the recall as the most serious type, saying “use of these devices may cause serious injuries or deaths.”

    According to the Washington Post, millions of patients have been left in limbo while they wait for their devices to be repaired or replaced.

    “In May, the FDA announced it had received 21,000 reports, including 124 deaths, concerning the breakdown of the polyester-based polyurethane foam in sleep apnea machines and ventilators during the past year — a sharp increase from 30 the previous decade.”

    How long has the maker of CPAP machines known there was a problem? Why didn’t the FDA discover this problem on its own? What should it do about the CPAP crisis?

    Some Recommendations from The People’s Pharmacy:

    Here are some of our suggestions:

    • 1) The president should invoke the Defense Production Act to increase the manufacture of chips specifically for these medical devices.
    • 2) Philips Respironics should prioritize delivering CPAP machines to people who are most vulnerable. The company should also communicate directly to every patient.
    • 3) The FDA should be more proactive regarding critical medical devices so that a life-threatening shortage of this sort never happens again.

    What Do You Think?

    We would love to read your thoughts about the CPAP crisis in the comment section below. Do you know someone who snores and has obstructive sleep apnea? Have they ever used a CPAP machine? Has their device been recalled? What are they doing now?

    If you think this article has merit, please send it to friends and family. We suspect that someone you know snores, has a sleep apnea and/or has a CPAP-type machine. They (and their health care providers) may not know about the problems with these devices. It’s super easy to share. Just scroll to the top of the page and click on the icons for email, Twitter and Facebook.

    While you are at it, please encourage your contacts to sign up for our free online newsletter. You may have noticed that Google accepts a lot of drug and device ads. Is it any wonder that articles like this disappear almost without a trace? The only way your acquaintances can read our independent voice is to subscribe to our newsletter at this link. Thank you for supporting our work!

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