In a surprising move, the U.S. Food and Drug Administration (FDA) has opted not to approve a needle-free alternative to the EpiPen for emergency treatment of severe allergic reactions. Approval of the Neffy nasal spray was widely anticipated. An FDA advisory panel voted to recommend approval of the drug for children and adults in May. While the FDA is not obligated to follow the advice of their advisory panels, it usually does. Instead, the FDA told the drug’s maker, ARS Pharmaceuticals, that it needed to conduct another study on the drug before it is approved, the company said in a statement late Tuesday night. “We are deeply disappointed that this action further delays the availability of Neffy for the millions of people who are at risk of a potentially life-threatening severe allergic reaction,” said Richard Lowenthal, co-founder, president and CEO of ARS Pharma. “We stand by the totality of the Neffy data package in a comprehensive registration program that was aligned upon with FDA and believe strongly in the value Neffy can provide for patients, families and caregivers living daily with severe allergic reactions,” he said in a company statement, adding that his firm will aim to complete the requested trial as soon as possible. The news was unwelcome on the front lines of health care. “It’s certainly disappointing as we were hoping to have…  read on >  read on >

Another diabetes drug maker is taking legal action against businesses in several states, alleging that they’re “fraudulently claiming” that their compounded products are the same as its medication. This time, it’s Eli Lilly suing certain medical spas, wellness centers and compounding pharmacies over its medication Mounjaro. Mounjaro contains the active ingredient tirzepatide and is approved by the U.S. Food and Drug Administration to treat type 2 diabetes. The lawsuits, filed Tuesday, are meant to stop the other companies from “the unlawful marketing and sale of non-FDA approved compounded products.” “Lilly filed this lawsuit to protect patients,” the company said in a statement issued Tuesday. “Lilly cannot validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product.” The company sells Mounjaro only in prefilled single-dose pens. “These entities should be stopped from providing drug products in violation of consumer protection laws, particularly where they promise their patients that their drugs offer the same safety profile and clinical benefits as Mounjaro,” the statement added. In June, Novo Nordisk sued businesses for making compounded versions of semaglutide, which is used in its type 2 diabetes drugs Ozempic and Rybelsus. The medication is also used to treat obesity under the brand name Wegovy. In its cases, Novo Nordisk has asked the companies “to cease and desist from false advertising, trademark infringement…  read on >  read on >

Before pouring another drink, consider this sobering new research: Heavy drinkers can develop fat around the heart, leading to heart failure and other cardiac problems. This so-called pericardial fat is associated with increased risk of heart disease. Researchers also linked heavy drinking to excess fat deposits around the liver and kidneys, which can result in diseases of these organs, too. “The accumulation of fats in these areas, especially at the heart, has been linked to higher risk of heart disease like heart failure, atrial fibrillation as well as coronary heart disease, which is the major killer of U.S. adults,” said lead researcher Dr. Richard Kazibwe, an assistant professor of internal medicine at Wake Forest University School of Medicine in Winston-Salem, N.C. Alcohol affects how the body handles fat, he said. “Drinking is a known risk for obesity. We know from the past that alcohol can influence metabolism. It can influence levels of hormones in the body that can lead to the distribution of fat in general, but also in various areas of the body,” Kazibwe said. That’s how fat ends up surrounding the heart, but if you stop imbibing will that fat disappear? Kazibwe said fat around the liver can be reduced if you stop drinking, but it isn’t known if the same is true for fat around the heart. The bottom line, in his…  read on >  read on >

California is on track to become the first state to ban four food additives that some experts have linked to health issues ranging from behavioral problems in children to reproductive issues to cancer in lab animals. On Tuesday, the legislature passed Assembly Bill 418, which now awaits the signature of Gov. Gavin Newsom. The substances are permitted by the U.S. Food and Drug Administration, so this would be the first time a state has banned items allowed by federal regulators. The chemicals are already illegal in the European Union and other places around the world, NBC News reported. The ingredients are red dye No. 3, potassium bromate, brominated vegetable oil and propylparaben. The restriction would begin in 2027. “It’s going to make our food supply much safer,” Assembly member Jesse Gabriel, who introduced the bill along with Assembly member Buffy Wicks, told NBC News. “It’s going to give parents more confidence that when they’re buying foods at the grocery store, they don’t have to worry that there’s something in there that’s dangerous for their kids.” Although red dye No. 3 is banned in cosmetics because of its history of causing cancer in lab animals in high doses, it’s still allowed as a food coloring. Potassium bromate allows bread and baked goods to rise higher and improves texture. Brominated vegetable oil keeps flavoring from floating to…  read on >  read on >

Following an approval granted Monday by the U.S. Food and Drug Administration, the U.S. Centers for Disease Control and Prevention on Tuesday signed off on new COVID boosters for Americans. “We have more tools than ever to prevent the worst outcomes from COVID-19,” CDC Director Dr. Mandy Cohen said in an agency news release announcing the approval. “[The] CDC is now recommending updated COVID-19 vaccination for everyone 6 months and older to better protect you and your loved ones.” Hours earlier, the CDC’s Advisory Committee on Immunization Practices (ACIP) had voted to support the boosters for all Americans aged 6 months and older. The COVID shots from Pfizer and Moderna will join the flu shot and newly approved RSV shots as part of a three-pronged public health strategy to tame the spread of all three viruses this coming winter. The updated COVID vaccines are each fully approved for those 12 and older and are authorized under emergency use for individuals 6 months through 11 years of age. “Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said Monday in an agency news release. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness and…  read on >  read on >

The U.S. Food and Drug Administration on Monday gave the green light to new COVID boosters for Americans, setting the stage for the updated vaccines to become available within days. The COVID-19 shots from Pfizer and Moderna will join the flu shot and newly approved RSV shots as part of a three-pronged public health strategy to tame the spread of all three viruses this coming winter. The updated COVID vaccines are each fully approved for those 12 and older and are authorized under emergency use for individuals 6 months through 11 years of age. “Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in an agency news release. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.” One infectious diseases expert said the approvals matter most to vulnerable Americans. “Having an updated booster that more closely matches circulating strains is an important tool for high-risk individuals, who still remain at risk for severe disease, hospitalization and death,” said Dr. Amesh Adalja, a senior scholar with Johns Hopkins’ Center for Health Security in Baltimore. Next up? The Advisory…  read on >  read on >

Winter months can be a challenge for those trying to keep their high blood pressure in check, new research suggests. In an analysis of more than 60,000 American adults being treated for high blood pressure at six health care centers in the Southeast and Midwest United States, scientists found that systolic blood pressure — the top number — rose slightly in winter months, by up to 1.7 mm Hg. Meanwhile, population blood pressure control rates decreased by 5% in the winter compared to control rates from the summer. These findings were presented Thursday at the American Heart Association’s Hypertension Scientific Sessions 2023. “Despite the smaller degree of systolic blood pressure variation in comparison to previous studies on seasonality in blood pressure, we were surprised to observe a large degree of change in blood pressure control between winter and summer months,” said study author Robert Barrett, a software engineer at the American Medical Association. “Individuals with hypertension or values near the range of hypertension may benefit from periodic blood pressure monitoring and improvements in physical activity and nutritional patterns during winter months, to offset adverse effects from seasonal blood pressure changes,” he said in a meeting news release. During the review, each of the participants remained on the blood pressure medication that had been prescribed for them. They were seen at centers ranging from small federally…  read on >  read on >

New COVID-19 booster shots could soon pass the needed hurdles for vaccinations to begin next week. Sources familiar with U.S. Food and Drug Administration plans say boosters could be approved as soon as Friday, NBC News reported. The U.S. Centers for Disease Control and Prevention Advisory Committee on Immunization Practices is scheduled to meet on Tuesday. CDC director Dr. Mandy Cohen could sign off soon after, allowing vaccinations to begin. The boosters from Pfizer and Moderna target the XBB.1.5 omicron subvariant. That’s no longer the dominant variant circulating, but those that are spreading are closely related, and health experts say this booster could still offer some protection. This time, the FDA may grant full approval for the boosters rather than emergency use authorization, according to NBC News sources. If the FDA doesn’t approve the boosters on Friday, it could do so early next week. While protection wanes over time, about 97% of adults have some level of protective immunity from past COVID infections and vaccinations. These shots are expected to boost that coverage. They will, however, come at a price. For the first time, the federal government is not covering costs of the shots. Most people with private and public health insurance should still be able to receive them for free. Those who are uninsured may be able to get them at community health centers.…  read on >  read on >