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The U.S. Food and Drug Administration on Monday approved a second nasal spray for reversing an opioid overdose. To be sold as Opvee, the spray contains the medication nalmefene hydrochloride and will be available to Americans aged 12 and older with a prescription, the FDA said. “The agency continues to advance the FDA Overdose Prevention Framework and take actionable steps that encourage harm reduction by supporting the development of novel overdose reversal products,” FDA Commissioner Dr. Robert Califf said in an agency news release. “On the heels of the FDA’s recent approval of the first over-the-counter opioid reversal agent [Narcan], the availability of nalmefene nasal spray places a new prescription opioid reversal option in the hands of communities, harm reduction groups and emergency responders,” Califf added. Indivior, which will make and sell Opvee going forward, said the spray should be available by October. Indivior bought Opiant Pharmaceuticals, which developed Opvee, in March. “Opvee’s FDA approval represents a significant achievement in the development of new treatment options to address today’s era of opioid overdoses that are driven by powerful synthetic opioids, such as fentanyl,” Indivior CEO Mark Crossley said in a company news release. “Opvee is an emergency treatment for the fast reversal of respiratory depression triggered by natural or synthetic opioids, including fentanyl, and we are committed to making this novel rescue medication widely available… read on > read on >

Maybe you can’t weed your garden without sneezing. Perhaps your eyes start watering when you clean your home. Did your skin begin itching last night during dinner? You may have an allergy, but you’re not alone. More than 50 million adults and children in the United States have a bad reaction to pollen, dust, mold, pet dander and other common allergens, according to the American College of Allergy, Asthma, & Immunology (ACAAI). What are allergies (allergic reactions)? An allergy is your body’s reaction to an allergen such as pollen, mold and more. Pollen causes a pollen allergy and mold causes a mold allergy. It’s your immune system that reacts. It is very important because it protects you from germs and viruses, but sometimes it gets confused. “Most people don’t have an immune response to pollen, but a certain percentage of people’s immune systems see it as foreign and dangerous, and they treat it like a pathogen or infection,” said Dr. Christina Price, an allergist and immunologist at Yale Medicine in New Haven, Conn. How your body treats allergens When your immune system decides that something might hurt you, it fights back. This fight triggers those miserable symptoms like shortness of breath, hives, sneezing and itching, the ACAAI explains. In other words, while trying to protect you, your body accidentally causes harm. The most common allergy… read on > read on >

Patients with Crohn’s disease have a new treatment option, following U.S. Food and Drug Administration approval of a pill called Rinvoq (upadacitinib). Rinvoq is meant to treat adults with moderately to severely active Crohn’s disease who have not had success with TNF (tumor necrosis factor) blockers. The daily pill is the first oral treatment for this group of patients. Crohn’s is a chronic inflammatory bowel disease. It causes inflammation in any part of the digestive tract, typically affecting the small intestine and the beginning of the large intestine. Common symptoms include diarrhea, cramping, stomach pain and weight loss. The medication was previously approved for several other conditions, including eczema, rheumatoid arthritis, psoriatic arthritis and ulcerative colitis, according to the website of pharmaceutical company AbbVie. Researchers evaluated its safety and effectiveness in two randomized trials in 857 patients with the disease. Participants received either 45 mg of Rinvoq or a placebo daily for 12 weeks. More patients treated with the medication achieved remission than those treated with the placebo, the FDA said in a news release. Also, more people treated with the medication had improvement in intestinal inflammation, which was assessed with a colonoscopy. The FDA also assessed Rinvoq as a maintenance treatment, evaluating 343 patients who had responded to the 12 weeks of medication. This group received 15 mg or 30 mg once daily or… read on > read on >

It’s well known that it’s unhealthy to have belly fat accumulating around your abdominal organs, but there’s a more insidious form of fat that could be even more hazardous to your health, a new study says. Fat that infiltrates your muscles appears to dramatically increase your risk of death, according to findings published May 16 in the journal Radiology. Fatty muscle — a condition called myosteatosis — was associated with a 15.5% increase in absolute risk of death in a group of healthy adults, researchers found. By comparison, obesity appeared to increase participants’ absolute mortality risk by only 7.6%, results show. Fatty liver disease raised risk by 8.5% and muscle wasting by 9.7%. “The signal [for muscle fat risk] was so much stronger for this otherwise healthy cohort,” said senior researcher Dr. Perry Pickhardt, chief of gastrointestinal imaging at the University of Wisconsin School of Medicine and Public Health. “It really stood out as a strong biomarker beyond the things I think we all accept as important measures. “I think there’s going to be profiling of patients where if you line up myosteatosis with a very fatty liver or maybe abundant visceral fat, you might be a lot worse off than if you just had one of those or two of those,” Pickhardt added. Muscle fat has been a subject of increasing interest in the… read on > read on >

Men, want to burn fat? Chill out. New research shows that exposure to cold in the morning may help you burn more fat than at other times of day. Exposure to cold activates brown fat, producing heat to help the body maintain its temperature and burn calories, especially those from fat. That makes it an ideal way for guys to improve cardiometabolic health — preventable conditions like heart attack, diabetes and liver disease, for instance. Sorry, ladies. The same may not be true for you. “Our study indicates that the optimum time to undergo cold exposure is at a specific point in the body’s 24-hour cycle,” said study co-author Mariëtte Boon, of Leiden University Medical Center in the Netherlands. “It may also be that there is a sex difference in how the body responds to cold exposure with respect to boosting metabolism at a certain time point, and it appears that delivering cold exposure therapies in the morning may be more beneficial than the evening for men.” The investigators set out to determine whether there was a circadian (time-influenced) rhythm in humans’ brown fat activity, and if there were any differences between men and women. In rodents, brown fat metabolic activity fluctuates throughout the day, peaking just before waking up, the study authors noted. Heat production from food digestion and activity declines at night. Waking… read on > read on >

Skip artificial sweeteners if you’re trying to lose weight, warns the World Health Organization (WHO), noting the sugar substitutes aren’t effective for shedding pounds and may also cause harm. Long-term use of sugar substitutes may cause “potential undesirable effects,” according to new WHO guidance. This can include an “increased risk of type 2 diabetes, cardiovascular diseases, and mortality in adults,” CBS News reported. Consuming foods and beverages with ingredients like saccharin or sucralose or adding them to foods “does not confer any long-term benefit in reducing body fat in adults or children,” the WHO said after completing a systematic review. Among the artificial sweeteners WHO officials considered were acesulfame K, aspartame, advantame, cyclamates, neotame, saccharin, sucralose, stevia and stevia derivatives, according to the news report. “People need to consider other ways to reduce free sugars intake, such as consuming food with naturally occurring sugars, like fruit, or unsweetened food and beverages,” said Francesco Branca, WHO director for nutrition and food safety. Artificial sweeteners “are not essential dietary factors and have no nutritional value. People should reduce the sweetness of the diet altogether, starting early in life, to improve their health,” Branca added. These recommendations do not apply to people who already have diabetes, according to the review. That group was not included in the review. This isn’t the only time these artificial sweeteners have raised… read on > read on >

Vegan moms can breastfeed their children and not worry that their breast milk is missing essential nutrients, a new study finds. Researchers from Amsterdam University Medical Center in the Netherlands tested the milk of vegan mothers, finding it contains sufficient levels of vitamin B2 and carnitine. “The maternal diet greatly influences the nutritional composition of human milk, which is important for child development. With the rise of vegan diets worldwide, also by lactating mothers, there are concerns about the nutritional adequacy of their milk,” said lead researcher Dr. Hannah Juncker. “Therefore, it would be important to know if the milk concentrations of those nutrients are different in lactating women consuming a vegan diet,” she added in a medical center news release. Vegan diets are limited to plant-based foods. This type of eating includes fruits, vegetables, legumes, soy, nuts and nut butters but no animal-sourced foods. Although vitamin B2 and carnitine are found in highest concentrations in animal products, they were not missing in vegan moms’ breast milk, challenging assumptions that breastfed infants of these mothers may be deficient in these nutrients. The study used a technique that separates a sample into its individual parts and analyzes the mass of these parts. Vitamin B2 (riboflavin) is important for enzymes involved in many biological pathways. A shortage can lead to anemia and neurological problems in infants, the… read on > read on >

It’s important to ask questions when your doctor or dentist writes you a new prescription. This is especially true for opioid pain medications, such as hydrocodone, oxycodone or morphine. While these drugs are approved by the U.S. Food and Drug Administration for acute and chronic pain, they can have serious side effects, including addiction and even death. Misuse of opioids have led to the current drug overdose crisis in the United States. The majority of overdose deaths in this country involve opioids, according to the U.S. Centers for Disease Control and Prevention. The FDA offers some tips for using these medications safely. Start by asking your doctor how long your pain is likely to last and what medication is being prescribed. If the drug is an opioid, ask if there are non-opioid alternatives. If your doctor decides an opioid is best, ask how long you should take the medication. Find out when and how to stop using it. Ask for the lowest dose possible for the shortest time needed and in the smallest quantity, the FDA advised. Also ask about a follow-up appointment. While prescription opioids can be safe and effective, using them in a way that differs from what was prescribed or for non-medical reasons can lead to dependence, addiction and even death, the FDA cautioned. Side effects from opioid use include dizziness, drowsiness,… read on > read on >

The U.S. Food and Drug Administration on Friday approved the first nonhormonal medication aimed at easing menopause hot flashes. The new pill, called Veozah (fezolinetant), is from a class of drugs called neurokinin 3 (NK3) receptor antagonists. It targets a specific brain neuron that’s thought to be set off balance as estrogen levels naturally decline during menopause. “It works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature,” the FDA explained in a news release issued Friday. “Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Dr. Janet Maynard, who directs the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine at the agency’s Center for Drug Evaluation and Research. “The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women,” she said in the news release. According to the FDA, over 80% of menopausal women experience sudden, often debilitating hot flashes lasting several minutes that can be accompanied by sweating, flushing and chills. While estrogen-based hormone replacement therapy has long been used to help ease these symptoms, long-term use has been linked to a heightened risk for breast cancer and stroke. In addition, “some… read on > read on >

Outside advisors for the U.S. Food and Drug Administration voted Thursday to recommend approval of Neffy, the first epinephrine nasal spray for severe allergic reactions. Although most of the Pulmonary-Allergy Drugs Advisory Committee members supported the spray for adults (16:6) and children (17:5), key questions linger about whether more data is needed from its maker, ARS Pharmaceuticals, CBS News reported. But Richard Lowenthal, co-founder, president and CEO at ARS, said in a company statement following the vote that, “We believe our clinical data from more than 600 individuals demonstrate Neffy’s absorption-enhancing nasal spray technology is comparable to injectable products in delivering potentially lifesaving epinephrine, but with unique advantages of being small, needle-free and conveniently sized.” Lowenthal added, “We are committed to making it easier for patients and caregivers to carry and administer epinephrine without the anxiety and hesitation associated with using a needle-based device.” Neffy delivers a 2-milligram dose of epinephrine. Instead of large clinical trials, the drug company compared its product to already approved injectable epinephrine products, such as the EpiPen. It showed the results for Neffy were neither substantially higher or lower than injectable epinephrine. “Patients need options — with different administration methods — to facilitate actual epinephrine use in an emergency event,” Dr. Carlos Camargo, a professor of emergency medicine at Harvard Medical School in Boston, said in the company’s news release.… read on > read on >