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Regulators want your next tattoo to be as safe as it is trendy. The U.S. Food and Drug Administration has issued a draft of new guidance aimed at helping manufacturers and distributors of tattoo inks prevent microbial contamination. “With about 30% of people living in the U.S. having a tattoo, it’s imperative that the FDA take all necessary steps to help ensure that tattoo inks are free of contamination,” said FDA Chief Scientist Namandjé Bumpus. “Pathogens or other harmful substances in these inks can cause infections and serious injuries,” she said in an agency news release. “The FDA is issuing this draft guidance to help tattoo ink manufacturers and distributors recognize situations in which tattoo ink may become contaminated with microorganisms and take steps to protect public health.” The FDA issued a safety alert on tattoo inks in May 2019. It advised consumers, tattoo artists and retailers to avoid using or selling certain tainted inks. Many people have reported to federal regulators illness caused by contaminated tattoo inks. Testing has found that many sealed tattoo inks in the United States have microbial contamination. “Unlike most cosmetics, tattoo inks are injected into the dermal layer of the skin, and therefore have the potential to introduce harmful pathogens directly into the body. Because of this, it is particularly important for tattoo inks to be manufactured using methods… read on > read on >

COVID-19 boosters may be offered this fall, but first scientists need to determine what strains to target and who should receive the shots. Advisers to the U.S. Food and Drug Administration are slated to meet Thursday to discuss plans for fall, a decision with a deadline because drugmakers will need to have the time to manufacture the shots, NBC News reported. The process is similar to deciding on an annual flu vaccine. FDA scientists said redesigned boosters should target at least one variant of XBB, according to briefing documents published Monday. XBB strains have been spreading since last fall and are related to an omicron subvariant. “These data suggest that an updated strain composition of COVID-19 vaccines to more closely match currently circulating omicron sublineages is warranted for the 2023-2024 vaccination campaign,” the scientists wrote. The World Health Organization and the European Medicines Agency have both said a booster should target an XBB subvariant. As the virus has changed, vaccines have evolved, from a shot in December 2020 that targeted the original virus to FDA-approved shots last fall that targeted the original COVID strain as well as the omicron subvariants BA.4 and BA.5. XBB 1.5 is the dominant strain now circulating, with 40% of new cases having this strain, according to the U.S. Centers for Disease Control and Prevention. About 18% of new cases have… read on > read on >

The lung cancer drug alectinib (Alecensa) is more potent when taken with a fuller breakfast, or lunch, than when taken with a low-fat breakfast, researchers report. The Dutch team evaluated 20 patients who took one of two daily doses of alectinib with either low-fat yogurt alone, a full continental breakfast, or a lunch of their choosing. Low-fat yogurt resulted in 14% less exposure to the drug than a continental breakfast, and 20% less than lunch, the researchers found. The report was published June 12 in the JNCCN, Journal of the National Comprehensive Cancer Network. “This is important information for patients, since we know that higher alectinib concentrations in blood could result in more efficacy of the drug, a longer treatment duration and therefore, hopefully, a better survival,” said lead researcher Daan Lanser, from the Erasmus Cancer Institute at Erasmus University Medical Center in the Netherlands. “Sometimes, we hear that patients are advised to take their twice daily alectinib strictly 12 hours apart, with the result that some patients will take it with just a small snack in the morning or evening. We believe that taking it with a substantial meal containing enough fat is far more important for the absorption and efficacy of the treatment than to wait 12 hours between doses,” Lanser said in a journal news release. “This important study highlights the key… read on > read on >

Every grocery shopper must pass through the “temptation alley” that is the checkout aisle, surrounded by candy bars, salty snacks and sugary sodas. Those who’d like a healthy option for an impulse buy while they wait in line — fruit, veggies, nuts or water — will be left wanting, a new study says. About 70% of foods and beverages offered at checkout stands are unhealthy, according to a new study in Current Developments in Nutrition. Further, 9 out of 10 (89%) snack-sized options in the checkout aisle are junk food, researchers found. The presence of so much junk food in the checkout lane is calculated, said lead researcher Jennifer Falbe, an associate professor of nutrition and human development at the University of California, Davis. “Many of us go shopping thinking that we make choices in a neutral environment, but our findings indicate that is not the case,” Falbe said. “Certain products are preferentially promoted over others — in this case, unhealthy products at the checkout — and this can affect consumer decisions.” Prior research has shown that items offered there aren’t necessarily in high demand by consumers or represent a high profit margin for the supermarket, Falbe said. “What you see at checkout is often there because a big food or beverage company paid the store to place their products there,” Falbe said. “The checkout… read on > read on >

With the United States facing a high number of drug shortages, a Chinese company may help to boost the supply of one in particular, the chemotherapy agent cisplatin. The U.S. Food and Drug Administration is working with the Chinese drugmaker Qilu Pharmaceutical to import the widely used cancer drug. The Canadian pharmaceutical company Apotex will distribute the medication in 50-milligram vials, CNN reported. Health care providers can begin ordering the drug on Tuesday. “The FDA recognizes the importance of a stable, safe supply of critical drugs used in oncology, especially those used in potentially curative or life-extending situations,” said FDA Commissioner Dr. Robert Califf on Twitter late Friday. “Today, we’ve taken steps for temporary importation of certain foreign-approved versions of cisplatin products from FDA-registered facilities and used regulatory discretion for continued supply of other cisplatin and carboplatin products to help meet patient needs.” Califf stressed that in these situations regulators carefully assess product quality and require companies to take certain measures to ensure the products are safe for patients. “The public should rest assured that we will continue all efforts within our authority to help the industry that manufactures and distributes these drugs meet all patient needs for the oncology drugs impacted by shortages,” he added. The near-record number of drug shortages has had a big effect on cancer treatments, with about two dozen chemotherapy… read on > read on >

Many men will put off going to the doctor unless they are really sick, but men’s health screenings help catch problems before symptoms appear. So, how can you tell if a health screening or preventive care appointment is right for you? The U.S. National Institutes of Health (NIH), the Centers for Disease Control and Prevention and the National Library of Medicine offer several men’s health screening and preventative care recommendations. Many of these recommendations are guided by the U.S. Preventive Services Task Force (USPSTF), which is made up of experts in primary care and disease prevention. Here’s a comprehensive guide, based on this expert advice, to the most important men’s health screenings you need — and how often you should go — to stay on top of your health. Physical exam When to get it: Start at age 18 How often: Periodically or annually if aged 65 and older Regular exams by your doctor are used to screen for current and potential medical issues. A physical exam may include: Checking your height, weight and body mass index Discussing healthy lifestyle practices Updating your vaccinations Talking about health issues or medical concerns you have Asking about your diet plan, exercise routine, and alcohol and tobacco use Asking if you’re experiencing any issues with anxiety and depression If you’re aged 65 and older, checking your blood pressure… read on > read on >

It’s tempting to treat little skin bumps on your own, but that delays proper diagnosis and treatment that may work better, federal regulators cautioned. Among the many types of skin conditions a person can contract are a virus called molluscum, which look like white, pink or flesh-colored bumps. Products marketed as treatments for molluscum have not been approved by the U.S. Food and Drug Administration, the agency warned. There are no approved treatments in either prescription or over-the-counter form for the condition, which will typically go away on its own in six to 12 months but could last up to five years. Molluscum are sometimes called water warts. They can grow alone or in groups almost anywhere on the skin, including the face, neck, arms, legs, abdomen and genital area. They are rarely on the palms of the hands or soles of the feet. Sometimes these bumps itch and get irritated. People with a weakened immune system may have larger or more bumps. They’re more common in children, but can happen in teens and adults. Without seeing a doctor, you won’t know if what you have is actually molluscum or something else. Molluscum is spread by skin-to-skin contact, including sexual contact, and by sharing clothes or infected objects such as sports equipment. Staying clean, including washing your hands, is the best way to prevent them.… read on > read on >

Older adults may have a second vaccine option for RSV following the U.S. Food and Drug Administration’s approval of a Pfizer vaccine on Wednesday. The other shot for adults 60 and up is made by GSK. It was approved May 3. Both should be available by fall, before the seasonal spread of respiratory syncytial virus (RSV), The New York Times reported. The Pfizer vaccine, known as Abrysvo, has effectiveness of nearly 67% when a patient has two symptoms of RSV, such as a sore throat and cough. It’s 86% effective when three or more symptoms surface. Its GSK competitor — named Arexvy — was about 83% effective against severe RSV, the Times reported. The study on the Pfizer vaccine did include a concern about autoimmune syndromes. One patient among the 34,000 who received the vaccine in the study developed a life-threatening case of Guillain-Barré syndrome a week after receiving the shot. Another developed Miller Fisher syndrome, which is a subtype of that condition. That means the incidence rate for these syndromes is 1 in 9,000, higher than the 1 in 100,000 seen in the general population. FDA advisors voted 7 to 4 in favor of the vaccine’s safety and efficacy. It had voted 10 to 2 for the GSK vaccine, which was linked to similar cases. Advisers for the U.S. Centers for Disease Control and… read on > read on >

(HealthDay News) – Patients taking semaglutide for type 2 diabetes or weight loss should be careful about where they’re getting the medication, the U.S. Food and Drug Administration warned Tuesday. Shortages of the drug, commonly sold as Wegovy and Ozempic, has led to the making of compounded versions of the drugs, which is combining or mixing ingredients to meet patient needs. Compounders can make a version of a drug if the medication is in shortage and they meet requirements of the Federal Food, Drug and Cosmetic (FD&C) Act. But the FDA said it has received reports that some patients have had some problems after taking the compounded drugs. The agency warned that patients should not use a compounded drug if an approved drug is available. Patients and their doctors should also understand that the FDA does not review compounded drugs for safety, effectiveness or quality. Compounded medications are not FDA-approved. Among the issues are reports that compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. The salt forms are different active ingredients than those used in the approved drugs. The agency said it has expressed concern to the National Association of Boards of Pharmacy about the use of salt forms of semaglutide in these products. Patients intending to use semaglutide should have a prescription from a licensed health care provider… read on > read on >

You’ll likely lose some of your memory and thinking abilities as you age, but nutrients called flavanols might help thwart that decline, a new study suggests. Not getting enough flavanols — natural compounds found in fruits, vegetables and even chocolate — could be driving that age-related memory loss, researchers say. This research is the pinnacle of 15 years of work showing that flavanols seem to benefit the dentate gyrus, an area within the brain’s hippocampus that is critical to memory. “This is the first time we can conclude that flavanols are acting as a nutrient for the aging brain,” said Dr. Scott Small, a professor of neurology and director of the Alzheimer’s Disease Research Center at Columbia University College of Physicians and Surgeons. “We show in this study, because we had biomarkers of flavanols, that if you’re relatively deficient in your flavanols, that seems to be driving your age-related memory decline.” This study was funded by the U.S. National Institutes of Health and Mars Edge, a subsidiary of the candy company. It’s possible that just as babies need certain nutrients for their developing brains, the aging brain also requires specific nutrients for optimal health, Small said. Now that people live longer, scientists are looking into a series of recommendations of nutrients that are beneficial for the aging body and brain, he noted. “I’d like to… read on > read on >