Eats « Weekly Gravy

Pregnant women will no longer have any drug to prevent preterm birth after the maker of the only available treatment announced Tuesday that it will withdraw its product, Makena, from the market. Covis Pharma Group’s decision follows a U.S. Food and Drug Administration advisory panel vote last October that concluded the drug does not actually benefit newborns. “While we stand by Makena’s favorable benefit-risk profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down,” Covis chief innovation officer Raghav Chari said in a statement. Makena was approved 12 years ago as part of the FDA’s accelerated drug approval program after promising results from a 2011 study, The New York Times reported. A larger study in 2019 showed no benefit to pregnant women or their infants. The FDA has been proposing to remove Makena from the market since October 2020, a decision appealed by the drug maker, the Times reported. In October 2022, 15 FDA advisors voted that the study had not shown benefit. With one exception, they each voted for it to be withdrawn from the market. “I think that when we leave something on the market that hasn’t been shown to be effective, we lose out on other investigations that might be pursued,” Dr.… read on > read on >

U.S. Federal health officials have issued recall notices for two more brands of eyedrops. In the latest round of recalls, the U.S. Food and Drug Administration posted notices after the companies voluntarily pulled several lots of their eyedrops from the market. These recalls do not appear to be connected to other recent recalls or an outbreak in drug-resistant infections, the Associated Press reported. The companies involved in the recalls are Phoenix-based Pharmedica and Florida-based Apotex. Pharmedica is recalling its Purely Soothing 15% MSM Drops meant to treat eye irritation. The two lots were pulled because of problems “that could result in blindness,” the company said. People who have the eyedrops should immediately stop using them and return them to the store where they bought them, the company added. Meanwhile, Apotex is recalling six lots of prescription eyedrops distributed as Brimonidine Tartrate Ophthalmic Solution, 0.15%. They were sold between April 2022 and February 2023. These eyedrops are meant to treat glaucoma. Unfortunately, some of the eyedrop bottles have cracks in the caps, the company said. More information The U.S. National Eye Institute has more on eyedrops and the earlier recalls involving bacteria. SOURCES: U.S. Food and Drug Administration, recall notices, March 2, 2023 and March 3, 2023; Associated Press read on >

Consumers have been using a common over-the-counter oral decongestant known as phenylephrine for years, but that may not continue much longer. The U.S. Food and Drug Administration has asked a panel of its advisors to reassess the drug’s effectiveness. The medication’s safety isn’t in question, just whether it actually does what it claims to do. The FDA’s Nonprescription Drugs Advisory Committee will meet in April to consider the effectiveness of the oral version of phenylephrine. The same panel had decided the drug “may be effective” in a 2007 meeting following federal efforts to fight illegal manufacturing of methamphetamine, which required the decongestant known as pseudoephedrine to be sold behind pharmacy counters, CBS News reported. The FDA initially received a new petition to withdraw the medication back in 2015, submitted by University of Florida pharmacy professors Leslie Hendeles and Randy Hatton. The duo had cited new data that showed phenylephrine was not more effective than a placebo, CBS News reported. “Let me be clear, oral phenylephrine is not a safety risk,” Hatton told CBS News. “It just doesn’t work.” In 2022, both professors questioned the FDA’s inaction on their 2015 petition in a commentary in the Annals of Pharmacotherapy. “I get it. Risk takes priority. But eight years is long enough to wait, you know what I mean? That’s millions and millions of dollars wasted on… read on > read on >

Young adults in the United States carry an increasing burden of heart health risk factors, making it more likely they’ll suffer a heart attack and stroke as they age, a new study warns. More adults ages 20 to 44 are obese and diabetic than a decade ago, and they are more likely to have poorly controlled blood pressure, according to the study published March 5 in the Journal of the American Medical Association. Researchers also found that young Black and Hispanic adults are more likely to suffer from these risk factors than white young adults. “We’re witnessing a smoldering public health crisis,” said senior researcher Dr. Rishi Wadhera, section head of health policy and equity at Beth Israel Deaconess Medical Center’s Smith Center for Outcomes Research in Boston. “The onset of these risk factors earlier in life is associated with a higher lifetime risk of heart disease and potentially life-threatening cardiovascular conditions, like a heart attack or stroke,” Wadhera continued. “Our finding that the burden of many cardiovascular risk factors is rising in young adults could have major public health implications over the long-term, especially as the U.S. population ages.” These health problems in people so young are likely contributing to declining life expectancy in the United States, said Norrina Allen, director of the Institute for Public Health and Medicine at Northwestern University Feinberg School… read on > read on >

Swapping that steak for a fish filet or a veggie burger is not only good for your health, but the planet’s, too, a new study suggests. The study, published in the American Journal of Clinical Nutrition, ranked various diets based on two measures: nutritional quality and “carbon footprint.” And overall, non-meat diets came out on top, on both counts. Researchers found that on average, vegan and vegetarian diets had the smallest carbon footprint — which refers to the amount of greenhouse gases that are churned into the atmosphere in order to produce the foods the diets comprise. Meanwhile, the pescatarian diet — which includes seafood, but no meat — scored highest in nutritional quality, and was more planet-friendly than diets containing meat. On the opposite end of the spectrum were two diets currently in vogue: the high-fat, low-carbohydrate keto diet; and the paleo diet, which centers on foods its proponents say were consumed in prehistoric times — mainly meat, fish, eggs, nuts and vegetables. Those two meat-heavy eating plans, the study found, carried the biggest carbon footprints and lowest dietary quality. (The keto diet may also be tough on the heart, raising levels of “bad” cholesterol and the risk of artery blockages, according to new research presented at a meeting of the American College of Cardiology). Experts said the findings may give consumers some food… read on > read on >

A Mediterranean diet may help multiple sclerosis (MS) patients ward off damage to their thinking skills. New research finds that a diet rich in veggies, fruit, fish and healthy fat reduced their risk of developing memory loss as well as losing the ability to concentrate, learn new things or make decisions. A loss of such key mental skills, or “cognitive impairment,” is a common feature of MS, a neurological disease that short circuits critical communication between the brain and body. But the new analysis of diet and mental status among 563 people with MS linked the Mediterranean diet to a 20% lower risk for cognitive difficulties. “Mediterranean diet is a broad term and there are geographical variations,” said lead author Dr. Ilana Katz Sand, an associate professor of neurology at Icahn School of Medicine at Mount Sinai in New York City. “However, it refers to an overall pattern that favors fruits, vegetables, olive oil, nuts, fish, and whole grains and limits meats — particularly red meat — baked goods, and highly processed foods.” Prior research has suggested that Mediterranean diets “have broad health benefits,” Katz Sand added, including some protection against heart disease, obesity, cancer, diabetes, Alzheimer’s and overall mental health decline. “In this study,” she said, “we demonstrate a significant positive association between the level of alignment of one’s diet with a Mediterranean pattern… read on > read on >

Following hours of discussion over safety concerns, a U.S. Food and Drug Administration advisory panel on Wednesday recommended approval of a second RSV vaccine, this one made by GlaxoSmithKline, for use in Americans ages 60 and older. The panel’s recommendation was based largely on the results of a trial that tested the GlaxoSmithKline vaccine in the same age group. Those findings, published recently in the New England Journal of Medicine, showed that the shot lowered the risk of symptomatic illness by 83% and of severe illness by 94% in people ages 60 and up. In a two-part vote, the panel voted 10 to 2 in favor of the vaccine’s safety and unanimously on the shot’s effectiveness, the New York Times reported. Meanwhile, the same panel on Tuesday recommended the approval of an RSV vaccine known as RENOIR from Pfizer Inc. On both days, panel members debated the benefits of the vaccines for patients who overwhelmingly avoided hospitalization against rare reports of autoimmune conditions like Guillain-Barré syndrome that emerged shortly after the shots were administered. In addition, two people who were given the GSK vaccine developed acute disseminated encephalomyelitis, a neurological disorder with symptoms that include weakness and loss of vision. One person died. The company and the FDA consider the cases “possibly related” to the vaccine, noting that both patients also received a flu vaccine… read on > read on >

One group of Americans drinks more caffeinated beverages than all others. That’s people who smoke cigarettes and also have serious mental illness, including schizophrenia and bipolar disorder, according to new research. While Americans overall are drinking more caffeinated beverages than ever, this group consumes the highest amount and also has the highest risk of negative health consequences, said researcher Dr. Jill Williams, director of addiction psychiatry at Rutgers Robert Wood Johnson Medical School in New Jersey, and colleagues. “Caffeine is generally considered safe and even has some health benefits,” Williams said in a Rutgers news release. “But we just don’t understand the cognitive and psychiatric effects of high caffeine intake, especially among smokers with mental illness.” The researchers analyzed data from 248 adult smokers who were recruited during a previous study. Participants were either outpatients with schizophrenia or bipolar disorder or from a control group with no psychiatric diagnoses. Each smoked a pack a day. Researchers collected blood samples from the participants to measure their serum caffeine levels. Participants also completed surveys on smoking history, caffeine use, physical health and psychological symptoms. While caffeine intake was highest in those with bipolar disorder, followed by schizophrenia, it was lowest in the control group. Williams suggested several theories that might help explain why this connection exists. First, there’s a well-established association between caffeine and smoking. People who… read on > read on >

While adult bed rails are marketed with safety in mind, they need to be used with caution, the U.S. Food and Drug Administration advises. “Many death and injury reports related to entrapment and falls for adult portable bed rail products and hospital bed rails have been reported to the FDA and the CPSC [U.S. Consumer Product Safety Commission],” the FDA said in a new webpage. Use bed rails with care, especially with older adults and people with altered mental status, physical limitations and certain medical conditions, the FDA advised. The FDA regulates bedrails that are sold for medical purposes. These might be used to help someone who is disabled, injured or recovering from surgery to transfer in and out of bed, and reduce the risk of falling or fracture. Those not marketed for medical purposes are instead considered consumer products and are under the jurisdiction of the CPSC. Sometimes these types of equipment are called side rails, bed side rails, half rails, safety rails, bed handles, bed canes, assist bars, grab bars, and adult portable bed rails. The FDA’s new webpage explains some of the risks associated with bed rails and offers some safety advice. Bed rails typically are divided into three distinct types, according to the FDA. There are portable bed rails for adults, portable bed rails used for children, and hospital bed rails… read on > read on >

In a tight vote, U.S. Food and Drug Administration advisors on Tuesday recommended the approval of an RSV vaccine that could be used in Americans ages 60 and up. The vaccine, known as RENOIR, was developed by pharmaceutical giant Pfizer Inc. The same panel of advisors will weigh the potential approval of another respiratory syncytial virus (RSV) vaccine, this one from GlaxoSmithKline, on Wednesday. “In older adults, RSV can result in serious illness, hospitalization, or even death, so there is a significant need to protect this at-risk population,” Annaliesa Anderson, senior vice president and chief scientific officer for vaccine research and development at Pfizer, said in a news release announcing the panel decision. “We are encouraged by the outcome of today’s… meeting, as it is a testament to the strength of our science and dedication to bringing this important vaccine candidate to the market.” If the FDA follows the recommendation of its advisors, which it typically does, Pfizer’s vaccine would be the first shot to guard against RSV infection, NBC News reported. The U.S. Centers for Disease Control and Prevention would also need to recommend the single shot before it could become available to Americans. Still, the FDA advisors were divided in their recommendation. The panel voted 7-4, with one abstention, to recommend approval of the vaccine based on its efficacy, NBC News reported. FDA… read on > read on >