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Phillips Respironics, the company responsible for the recall of millions of defective sleep apnea machines since 2021, must overhaul its production of the machines before it can resume making them in the United States, federal officials announced Tuesday. Under a settlement reached with the company, Phillips must revamp its manufacturing and quality control systems and hire independent experts to vet the changes. Phillips must also continue to replace, repair or provide refunds to all U.S. customers who got defective devices, the court order stated. The action helps resolve one of the biggest medical device recalls in history, which has dragged on for nearly three years and involved 15 million devices worldwide, the U.S. Food and Drug Administration said. “The finalization of this decree is a significant milestone. Throughout this recall, we have provided patients with important health information by issuing numerous safety communications and have taken actions rarely used by the agency to help protect those impacted by this recall,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in an agency news release. “Today’s action is a culmination of those efforts and includes novel provisions aimed at helping ensure that patients receive the relief they have long deserved.” Most of the devices that have been recalled are continuous positive airway pressure (CPAP) machines. These devices force air through a… read on > read on >

The Environmental Protection Agency announced Wednesday that it has finalized a first-ever rule that will drastically lower the amount of PFAS, also known as “forever chemicals,” in the nation’s drinking water. “Drinking water contaminated with PFAS has plagued communities across this country for too long,” EPA Administrator Michael Regan said in an agency news release announcing the new rule. “That is why President Biden has made tackling PFAS a top priority, investing historic resources to address these harmful chemicals and protect communities nationwide.” Exposure to PFAS has been linked to various cancers, liver and heart issues, and immune and developmental damage to infants and children, the agency noted. The level of exposure is significant in the United States: A 2023 government study detected PFAS in nearly half of the country’s tap water. The new rule, which requires utilities to reduce PFAS to the lowest level they can reliably be measured, should lower PFAS exposure for approximately 100 million people, the agency noted. In addition to the new rule, the EPA also announced that nearly $1 billion in new funding should help states and territories implement PFAS testing and treatment at public water systems and help owners of private wells address PFAS contamination. While environmental experts and health advocates welcomed the news, water utilities warned the new rule will cost billions more than the EPA has estimated and fall hardest on… read on > read on >

Early-onset arthritis may hit as many as one in every four young people who undergo anterior cruciate ligament (ACL) reconstruction surgeries, new research warns. The arthritic pain emerges within 6 to 12 months post-surgery, according to Michigan State University (MSU) researchers. Many of these cases occur in people under 40 and go unrecognized and untreated. “We’re trying to change the narrative,” said study lead author Matthew Harkey, an assistant professor of kinesiology at MSU. “We see fairly young, active individuals experiencing extensive symptoms, but these symptoms are not interpreted by clinicians as something that may be related to osteoarthritis. Ignoring these symptoms might be setting them up to experience long-term decline and function.” Tears to the ACL ligament within the knee are common, and often corrected with a surgery that replaces the ligament with a graft. Over 400,000 ACL reconstructions are performed in the United States annually, according to the National Institutes of Health. In the new study, Harkey’s team examined outcomes for 82 people, ages 13 to 35, who underwent ACL reconstructive surgeries. Almost a quarter of the patients reported “persistent early arthritis symptoms from 6 to 12 months after knee surgery,” according to a university news release. In another Harkey-led study, data from 3,200 individuals supplied by the New Zealand ACL Registry showed that almost a third of patients developed arthritic pain within… read on > read on >

Wegovy, Ozempic and other drugs known as GLP-1 analogues have become wildly popular for controlling diabetes and helping folks lose weight. There were concerns that longer term use of the drugs might raise users’ odds for thyroid cancer, but a Swedish study of more than 435,000 people finds no evidence to support that notion. “Many people take these medicines, so it is important to study potential risks associated with them,” said study lead author Björn Pasternak. He’s principal researcher at the department of medicine at the Karolinska Institute in Stockholm. “Our study covers a broad group of patients and provides strong support that GLP-1 analogues are not associated with an increased risk of thyroid cancer,” he said in an institute news release. The findings were published April 9 in the BMJ. In the analysis, Pasternak’s team used data from a major Scandinavian database involving 145,000 people who were taking GLP-1 analogues such as liraglutide (Victoza) or semaglutide (Ozempic), and 290,000 people who were taking one of another class of diabetes drugs called DPP4 inhibitors. The study found no higher odds for thyroid cancer among folks taking GLP-1 analogues compared to those on DPP4 inhibitors. That finding was repeated when GLP-1 analogue users were compared to patients taking a third class of diabetes meds, called SGLT2 inhibitors. Study co-author Peter Ueda, an assistant professor of medicine… read on > read on >

A new drug can slash triglyceride levels nearly in half by targeting a genetic driver of high fat levels in the bloodstream, researchers said. The injectable drug, olezarsen, lowered triglyceride levels by 49% at the 50 milligram (mg) dose and by 53% at the 80 mg dose compared to a placebo, researchers reported April 7 in the New England Journal of Medicine. The findings were presented simultaneously at the American College of Cardiology’s annual meeting in Atlanta. The drug also reduced blood levels of two other contributors to clogged arteries, apolopoprotein B and “bad” cholesterol, results show. Olezarsen inhibits the activity of APOC3, a gene that typically restrains the liver’s ability to filter triglycerides out of the bloodstream, the researchers said. “These findings indicate that targeting APOC3 is a promising new pathway for lowering triglycerides and potentially reducing the risk of heart attack and stroke,” said researcher Dr. Brian Bergmark, of the Brigham and Women’s Hospital Division of Cardiovascular Medicine. Triglycerides are fatty particles in the bloodstream that contribute to the risk of heart disease, both on their own and in combination with “bad” LDL cholesterol, according to Harvard Medical School. For the study, researchers recruited 154 adults already on cholesterol-lowering therapy. They were split into three groups and assigned to either take a placebo or a low or high dose of olezarsen, through injections… read on > read on >

Teenagers suffering from anxiety, depression or bipolar disorder are likely to have a tougher time getting their driver’s license, a new study finds. Teens and young adults with these types of mood disorders are 30% less likely to obtain a driver’s license than peers without a mood disorder, researchers report April 8 in the journal JAMA Network Open. Youths with mood disorders also have nearly twice the risk of losing their license and a slightly elevated risk of crashing a vehicle, the researchers discovered. “Our results indicate that newly licensed youths with mood disorders have a greater risk of crashing than other young drivers, but that this is a manageable risk,” said senior researcher Allison Curry, an associate professor of pediatrics with the Children’s Hospital of Philadelphia (CHOP) Center for Injury Research and Prevention. As many as one in 10 teens and young adults have been diagnosed with a mood disorder, researchers said in background notes. These disorders often develop around the age a teen becomes eligible to get a driver’s license, researchers noted. However, skills required for safe driving — attention, memory, motor skills — are often impaired in those with mood disorders. For the study, researchers compared nearly 1,900 teens with mood disorders to more than 84,000 teens without such a disorder, all of whom were eligible to get their license. They linked… read on > read on >

There’s no evidence that acetaminophen use during pregnancy increases the risk of childhood autism, ADHD or intellectual disability, the largest study to date on the subject has concluded. The analysis of more than 2.4 million children born in Sweden included siblings not exposed to the drug before birth, researchers said. Siblings share genetics and upbringing, allowing researchers to weed out other factors that might contribute to autism, ADHD and developmental delays. In this study, researchers found no increased risk when they compared siblings exposed to acetaminophen in the womb to brothers or sisters who weren’t, according to results published April 9 in the Journal of the American Medical Association. “This study’s findings may be welcome news for birthing people who use acetaminophen as a pain or fever management option, since there are few safe alternatives for relief available,” said co-senior author Renee Gardner, a principal researcher with Sweden’s Karolinska Institute. “We hope that our results provide reassurance to expectant parents when faced with the sometimes fraught decision of whether to take these medications during pregnancy when suffering from pain or fever,” Gardner added. Acetaminophen is the active ingredient in Tylenol, and is also an ingredient in cold and flu remedies like Theraflu, Excedrin and Mucinex, researchers said in background notes. Concerns regarding the use of acetaminophen during pregnancy have grown in recent years. In 2021,… read on > read on >

People who’ve survived a heart attack and have been given a stent may be better off quitting low-dose aspirin a month after the procedure, a new study finds. The strategy is “beneficial by reducing major and minor bleeding through one year by more than 50 percent,” said study lead author Dr. Gregg Stone, a professor of medicine (cardiology) and population health science and policy at the Icahn School of Medicine at Mount Sinai, in New York City. “Moreover, there was no increase in adverse ischemic [artery-blocking] events” when folks stopped using aspirin early, “meaning continuing aspirin was causing harm without providing any benefit,” Stone added. His team presented its findings Sunday at the American College of Cardiology (ACC) annual meeting in Atlanta. The study was published simultaneously in The Lancet. For folks who’ve had a heart attack or are at very high risk of experiencing one, low-dose daily aspirin is often given to cut their odds for blocked arteries. However, long-term use of aspirin is also tied to another health danger: Bleeding. So, the duration of aspirin use has long been up for debate. In the new trial, outcomes were tracked for up to a year in over 3,400 heart patients treated at 58 centers in four countries. All the patients had undergone non-surgical, catheter-guided placement of a heart stent to open up a blocked… read on > read on >

Today is your last chance until 2044 to see a total eclipse of the sun in the continental United States. But be sure to protect your eyes if you plan to watch the moon block the sun’s rays, briefly plunging Earth into temporary darkness. “The eclipse will last a few minutes,” said Dr. David Hinkle, who chairs the Department of Opthalmology at Tulane University School of Medicine in New Orleans. “Eye damage can last a lifetime.” There is no time — none at all — when it’s safe to look at the eclipse without proper eye protection, he emphasized. That’s true whether you are in the path of totality or in a broader swath of the nation where the sun will only be partially blocked. Thirteen states from Texas to Maine are in the path of totality. Starting shortly after 1 p.m. Eastern time (ET), the moon will completely block the sun for one to four minutes. Looking directly at the sun is never a good idea. It can burn your retina, Hinkle warned. “The sun’s rays are powerful and can burn your retina very quickly,” Hinkle said in a Tulane news release. That’s because the eye’s cornea and lens focuses the sun’s light directly onto this thin layer of tissue inside the back of eye, causing a burn called solar retinopathy. This damage, which may… read on > read on >

New research questions the effectiveness of the U.S. Food and Drug Administration’s accelerated drug approval program after finding that many cancer drugs remain unproven five years later. The study, published Sunday in the Journal of the American Medical Association and presented simultaneously at the American Association of Cancer Research’s annual meeting in San Diego, found that 46 cancer drugs were granted accelerated approval between 2013 and 2017. Of those, 41% showed no benefit after five years of follow-up. And of the 63% that were converted to regular approval, less than half (43%) demonstrated any clinical benefit in confirmatory trials. “Five years after the initial accelerated approval, you should have a definitive answer,” Dr. Ezekiel Emanuel, a cancer specialist and bioethicist at the University of Pennsylvania who was not involved in the study, told the Associated Press. “Thousands of people are getting those drugs. That seems a mistake if we don’t know whether they work or not.” First created in 1992 to get new HIV drugs to desperate patients as quickly as possible, more than 80% of the program’s accelerated approvals now go to cancer drugs, researchers found. The program allows the FDA to grant early approval to drugs that show promising results for treating debilitating or fatal diseases. In exchange, drug companies are expected to do rigorous testing and produce better evidence before gaining full… read on > read on >

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All Sauce from Weekly Gravy:

Company Behind Defective CPAP Machines Must Make Changes Before U.S. Production Resumes

EPA Sets Strict Limit on PFAS ‘Forever Chemicals’ in U.S. Drinking Water

Arthritis Can Often Follow ACL Surgeries in Young Adults

Ozempic, Wegovy Won’t Boost Thyroid Cancer Risk: Study

New Drug Could Slash Blood Triglyceride Levels

Teens with Anxiety, Mood Disorders Less Likely to Get Driver’s License

Acetaminophen Use During Pregnancy Poses No Risk of Autism, ADHD in Kids

Stopping Aspirin a Month After Stent Implant Helps Heart Patients

Watching the Solar Eclipse, Safely

Many Cancer Drugs Still Unproven 5 Years After Accelerated Approval