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The U.S. Food and Drug Administration’s tobacco unit is “reactive and overwhelmed,” an expert panel reviewing its work reported Monday. In addition, the panel blamed the FDA’s inconsistent regulation efforts for the spread of unauthorized e-cigarettes that are appealing to teens, among other problems. Commissioned by FDA chief Dr. Robert Califf this summer, the review was done by a panel convened by the nonprofit Reagan-Udall Foundation. “This work is particularly critical as we focus on preventing initiation, while also helping people quit, especially the deadliest form of tobacco use, combustible tobacco products,” Califf said in a news release announcing the release of the report. “Despite meaningful declines in cigarette use over the past several decades, nearly 500,000 Americans still die every year from cigarette smoking. Additionally, with more than 3 million youth reporting current use of a tobacco product in 2022, and e-cigarettes being the most used product, we risk another generation becoming addicted to these products.” Califf added that he plans to review the recommendations and develop an action plan by February. In the report, the experts recommended agency leaders set clear objectives and expectations to prevent more “detrimental” effects on the FDA’s work and staff morale. “Something is wrong if FDA can be given these amazing powers in 2009 and here we are at the end of 2022 and it has yet to… read on > read on >

Red may be a traditional holiday color, but no one wants to wear it on their teeth. An expert offers some tips for keeping “wine teeth” at bay during your holiday parties. “When you drink red wine, you’re encountering a triple threat to your teeth’s whiteness: anthocyanins, which are the pigments in grapes that give red wine its rich color; tannins, which help bind the pigment to your teeth; and the acidity found in wine, which etches your enamel, making it more porous and it easier for the stain to stick,” said Dr. Uchenna Akosa. She is a dentist who heads Rutgers Health University Dental Associates in New Brunswick, N.J. “The strength of your enamel and how prone you are to plaque build-up is key to how much your teeth might stain,” Akosa said. Brush before you drink red wine, she advised. And don’t brush immediately after drinking. Plaque can make it look like your teeth are stained, so brushing 30 minutes beforehand can reduce that issue. And toothpaste itself can cause more etching if you brush afterward. Another tip: Don’t drink white wine before red wine, because the extra acid in the white wine will worsen the staining. After drinking wine, swish your mouth with water. This reduces acidity and increases saliva flow, which fights harmful bacteria and maintains the ideal pH in your… read on > read on >

Patients with a high-risk bladder cancer now have a new option to treat it. The U.S. Food and Drug Administration on Friday approved a gene therapy called Adstiladrin, which is designed to work for patients who have what’s called high-risk non-muscle-invasive bladder cancer (NMIBC) that hasn’t responded to the standard treatment, Bacillus Calmette-Guérin (BCG), but hasn’t spread. BCG is a vaccine typically used for tuberculosis. “This approval provides health care professionals with an innovative treatment option for patients with high-risk NMIBC that is unresponsive to BCG therapy,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in an agency news release. “Today’s action addresses an area of critical need. The FDA remains committed to facilitating the development and approval of safe and effective cancer treatments.” About 75% to 80% of newly diagnosed bladder cancers have grown through the lining of the bladder, but not yet invaded the muscle. About 30% to 80% of cases recur and risk spreading. Treatment typically involves removing the tumor and using BCG to reduce the risk that the cancer will recur. But for patients whose cancer is unresponsive to BCG, there are few treatment options. Patients will receive Adstiladrin once every three months into the bladder through a urinary catheter. About 57,000 men and 18,000 women are diagnosed with bladder cancer annually, according to the… read on > read on >

MONDAY, Dec. 19, 2022 (HealthDay News) – Add better chances of conceiving a baby to the list of health benefits linked to the much-touted Mediterranean diet. The Mediterranean diet – which is rich in fresh fruits and veggies, healthy fats like olive oil, whole grains, legumes, nuts and fish – has been shown to boost brain health, and reduce the risk for heart disease, diabetes and certain cancers. Now, researchers in Australia report that this style of eating also can improve fertility, the chances of success with assisted reproductive technology, and sperm quality in men. The common denominator? Inflammation. “Our review demonstrates that the Mediterranean Diet may also increase fertility and provide benefits for couples who are trying to have children,” said study author Simon Alesi, a researcher at Monash University in Melbourne. “Inflammation is increasingly recognized as a factor that contributes to poor reproductive and fertility outcomes, often termed ‘inflammatory infertility’ in the evidence,” Alesi said. “And the bionutrients in the Mediterranean diet such as monounsaturated fats, flavonoids, vitamins C and E, polyphenols, and the limited intake of processed meat, are likely to reduce inflammation in the body, thus improving fertility.” By contrast, the traditional Western diet, which is low in fruits and vegetables and high in fat and sodium, has been linked to more inflammation and other health problems. For this study, researchers… read on > read on >

Bees, in their role as master pollinators, increase crop yields, leading to more production of healthy fruits, vegetables and nuts. But new research claims that the challenges these important insects face from changes in land use, harmful pesticides and climate change is affecting food production, leading to less healthy food in global diets and more diseases causing excess deaths. “A critical missing piece in the biodiversity discussion has been a lack of direct linkages to human health. This research establishes that loss of pollinators is already impacting health on a scale with other global health risk factors, such as prostate cancer or substance use disorders,” said senior study author Samuel Myers. He is a principal research scientist of planetary health in the department of environmental health at the Harvard T.H. Chan School of Public Health, in Boston. Inadequate pollination has led to a 3% to 5% loss of produce and nut production, according to the study. That is associated with an estimated 427,000 excess deaths annually from illnesses such as heart disease, stroke, diabetes and certain cancers, the researchers said. A 1% to 2% annual decline of insect populations has led some to warn of an “insect apocalypse” that will come in the decades ahead. Pollinators would be part of that, seriously affecting healthy food supply because they increase the yields of three-fourths of crop… read on > read on >

Babies born prematurely who are fed formula may need iron supplementation like their breastfed counterparts, new research suggests. “Just because a baby is on iron-rich formula, we should not assume all of their iron needs are being met, since iron from the formula may not have the same absorption as iron from breast milk,” said researcher Grace Power. She is a third-year medical student at Dalhousie University in Nova Scotia, Canada. “These findings suggest we might need to rethink some of the guidelines for iron supplementation,” she said in a news release from the American Society of Hematology. Currently, the Canadian Pediatric Society recommends iron supplementation for breastfed preterm babies, but not for those fed formula because the formula contains more iron than breastmilk. The American Academy of Pediatrics does not offer recommendations on iron supplementation for preterm babies. For the new study, the researchers analyzed health records from 392 infants born before 31 weeks’ gestational age in Nova Scotia from 2005 to 2018. The data set is considered to be representative of the general Canadian population. About three-quarters of the infants in the study were exclusively fed iron-rich formula. The other one-quarter were partially or exclusively breastfed. The investigators gathered data on feeding practices, iron intake from formula and iron supplements, and iron levels in the blood taken at 4 and 6 months of… read on > read on >

Owners whose cats have diabetes now have a new option to care for the condition in their otherwise healthy pets. The U.S. Food and Drug Administration on Thursday approved the first pill to improve control of diabetes in some cats. The drug, called Bexacat (bexagliflozin tablets), is not insulin and is not meant for cats who have the type of diabetes that requires treatment with insulin. Rather, it is what is called a sodium-glucose cotransporter 2 (SGLT2) inhibitor. The active ingredient in this pill prevents the cat’s kidneys from reabsorbing glucose into the blood. This excess glucose leaves the body through the urine, lowering blood sugar levels. As part of the approval, the FDA requires that Bexacat labels include a boxed warning about the importance of patient selection. Only certain cats should take the drug, determined through careful screening. Potential patients must be screened for kidney, liver and pancreatic disease, as well as ketoacidosis, a high level of a type of acids known as ketones in the blood. Bexacat also shouldn’t be used in cats who are being treated with insulin or in those who have previously been treated with insulin. The drug should not be started in cats who are not eating well or who are dehydrated or lethargic at diagnosis. Cats taking this medication should be monitored regularly with exams and blood tests,… read on > read on >

The updated bivalent COVID-19 boosters are now approved for use in children as young as 6 months of age, the U.S. Food and Drug Administration announced today. Children can receive either a Moderna or Pfizer-BioNTech bivalent booster shot, although the rules differ depending on their age and what type of vaccine they got as their primary series, the FDA said. Kids 6 months to 5 years who received the original Moderna vaccine can receive the Moderna booster at least two months after completing their first round of shots. Children 5 and older also can receive the Pfizer-BioNTech booster at least two months after they’ve completed their first series of COVID shots. The new Pfizer-BioNTech booster will replace the third dose of the primary series of shots for that vaccine for children 6 months through 4 years of age, the FDA said. But children 4 and younger who already completed the three-dose Pfizer-BioNTech primary series will not be eligible for the bivalent booster at this time, the agency said. The FDA will decide on the updated booster for this group of kids after January, when fresh data is expected. The updated boosters contain two components to protect against both the original strain of COVID and widely circulating Omicron variants. “More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine,… read on > read on >

THURSDAY, Dec. 8, 2022 (HealthDay News) – Lasik eye surgery is a common vision-correcting procedure that many Americans view as safe and effective, but the U.S. Food and Drug Administration has now drafted guidance that warns of potential complications. Although many patients are happy with the results after surgery, the recommended new guidance says complications can include dry eyes, double vision, difficulty with night driving and, in rare cases, chronic eye pain. Even after surgery, some patients will still need eyeglasses. The draft also notes that certain types of patients may be at higher risk of problems, including people with chronic conditions such as diabetes and those who take certain medications, the New York Times reported. Since the recommendations were first released this summer, more than 600 people and professional organizations have weighed in on the issue. “All we’re asking for is balance,”said Dr. Vance Thompson, incoming vice president of the American Society of Cataract and Refractive Surgery, told the Times. “This document mainly emphasizes the dangers and complications of Lasik, with no mention of the advantages, and the tone is negative enough that it will scare patients.” Thompson noted that more than 90% of patients in the FDA’s studies were satisfied because they were “achieving good vision without spectacles, which is the goal of most patients.” Surgeons and device manufacturers have sought to have… read on > read on >

Statins may do more than help your heart: New research shows the cholesterol-lowering drugs may also lower your risk for a bleeding stroke. An intracerebral hemorrhage, which involves bleeding in the brain, comprises about 15% to 30% of strokes, according to the American Association of Neurological Surgeons. It is also the most deadly. With this type of stroke, arteries or veins rupture, and the bleeding itself can damage brain tissue. The extra blood in the brain may also increase pressure within the skull to a point that further harms the brain. “While statins have been shown to reduce the risk of stroke from blood clots, there has been conflicting research on whether statin use increases or decreases the risk of a person having a first intracerebral hemorrhage,” said study author Dr. David Gaist, of the University of Southern Denmark in Odense. “For our study, we looked at the lobe and non-lobe areas of the brain, to see if location was a factor for statin use and the risk of a first intracerebral hemorrhage,” Gaist said. “We found that those who used a statin had a lower risk of this type of bleeding stroke in both areas of the brain. The risk was even lower with long-term statin use.” The researchers used health records in Denmark, identifying 989 people who had an intracerebral hemorrhage in the… read on > read on >