31 August 2018
FRIDAY, Aug. 31, 2018 (HealthDay News) — You risk serious injury if you consume or handle food and drink products where liquid nitrogen is added just before consumption, the U.S. Food and Drug Administration warned Friday. These products — which have names such as “Dragon’s Breath,” “Heaven’s Breath” and “nitro puff” — are available in food courts, kiosks, state or local fairs, and other places where food and drinks are sold. Examples of such products include liquid nitrogen-infused colorful cereal or cheese puffs that emit a misty or smoke-like vapor, and alcoholic and nonalcoholic drinks prepared with liquid nitrogen that emit a fog. Liquid nitrogen isn’t toxic, but its extremely low temperature can cause severe damage to skin and internal organs if mishandled or consumed, the FDA said in a news release. Inhaling the vapor released by liquid nitrogen in food or drinks can also cause breathing problems, especially among people with asthma, according to the agency. “The main issue is that liquid nitrogen must be fully evaporated from food or beverage before it is served,” explained Dr. Robert Glatter, an emergency room physician at Lenox Hill Hospital in New York City. “In liquid form, it can cause burns to the mouth, esophagus and upper airway, leading to perforation or rupture of the organs — which could be deadly,” Glatter said. “It may also cause burns of the fingers or hands when it is handled in the liquid state.” And people with asthma or lung disease who inhale the vapors might experience constriction of their airways, triggering an asthma attack or worsening of their lung disease, he added. “Beyond this, it may also lead to inflammation in the lungs and aspiration, which can reduce the ability to breathe, as well as trigger infections such as pneumonia,” Glatter said. In fact, the FDA said it has received reports of severe and life-threatening injuries caused by liquid nitrogen in food and drinks, and also reports of breathing problems. “With state fairs upon us, parents and teens need to understand the potential risks of foods such as nitro popcorn and nitrogen-infused cereals, which promise excitement and thrill but may end with a trip to the emergency department,” Glatter noted. People who’ve suffered an injury after handling or consuming food or drinks prepared with liquid nitrogen should consult a health care provider, and also consider reporting their injury to MedWatch, the FDA’s safety reporting program, the agency said. More information The U.S. Food and Drug Administration has more on food safety.
30 August 2018
THURSDAY, Aug. 30, 2018 (HealthDay News) — Rare but serious genital infections, as well as one death, have been reported in some patients taking a certain class of type 2 diabetes medicine, the U.S. Food and Drug Administration says. As a result, the FDA has ordered a new warning about this risk to be added to the prescribing information and patient medication guide of all sodium-glucose cotransporter-2 (SGLT2) inhibitors. The bacterial infection of the genitals and area around the genitals is called necrotizing fasciitis of the perineum, also called Fournier’s gangrene. The bacteria typically enter the body through a cut or break in the skin. Between March 2013 and May 2018, the FDA identified 12 cases of Fournier’s gangrene in patients taking an SGLT2 inhibitor. However, this number includes only reported cases and those found in the medical literature, so there may be more cases, the FDA said in a news release. Fournier’s gangrene developed within several months after the 12 patients starting taking an SGLT2 inhibitor, and use of the drug was stopped in most cases. All 12 patients were hospitalized and required surgery. Some patients required multiple disfiguring surgeries, some developed complications, and one patient died, according to the FDA. A review of more than 30 years of data identified only six cases of Fournier’s gangrene among patients taking other classes of diabetes drugs, the FDA said. All six of those cases occurred in men, but five of the 12 recently reported cases involved women. In 2017, about 1.7 million U.S. patients filled prescriptions for an SGLT2 inhibitor at outpatient retail pharmacies, the FDA said. SGLT2 inhibitors were first approved by the FDA in 2013, and include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin. Brand names of FDA-approved SGLT2 inhibitors include Invokana, Invokamet, Invokamet XR, Farxiga, Xigduo XR, Qtern, Jardiance, Glyxambi, Synjardy, Synjardy XR, Steglatro, Segluromet and Steglujan. Patients taking these drugs should seek medical attention immediately if they have any tenderness, redness or swelling of the genitals, or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell, the FDA advised. The agency said health care providers should assess patients for Fournier’s gangrene if they have such symptoms. If Fournier’s gangrene is suspected, start treatment immediately with broad-spectrum antibiotics and surgery if necessary, discontinue the SGLT2 inhibitor, closely monitor blood sugar levels, and provide appropriate alternative therapy for blood sugar control, the agency added. More information The National Organization for Rare Disorders has more on Fournier’s gangrene.
30 August 2018
THURSDAY, Aug. 30, 2018 (HealthDay News) — People with sleep apnea have higher chances of developing gout, a new study suggests. Researchers analyzed data on nearly 16,000 people with sleep apnea and more than 63,000 people without apnea who were followed for a median of nearly six years. (Half were followed longer, half for less time.) Overall, 4.9 percent of sleep apnea patients and 2.6 percent of the others developed gout. People with sleep apnea had a 42 percent higher risk of gout, the study found. The increased risk was highest one to two years after sleep apnea diagnosis, and was greater for patients with normal body weight than among those who were overweight or obese, the researchers said. Of course, the study couldn’t prove that apnea causes gout, just that there was an association. Gout is a painful form of arthritis caused by a buildup of uric acid in the body. It causes swollen, red, hot and stiff joints. The study was published Aug. 30 in the journal Arthritis & Rheumatology. “People with sleep apnea are at an increased risk of gout in both the short and long term. Since this risk was highest in people with normal body mass index, doctors and other health professionals should consider the possibility of gout in patients with sleep apnea regardless of body mass index,” study co-leader Edward Roddy said in a journal news release. Roddy is a clinical lecturer in rheumatology at Keele University in Staffordshire, England. It’s believed that periodic low levels of oxygen caused by sleep apnea lead to overproduction of uric acid, causing gout, the researchers said. “Sleep apnea is commonly treated with continuous positive airways pressure — or CPAP — therapy. Since CPAP treatment corrects low oxygen levels it might also be expected to reduce uric acid levels, which could possibly reduce the risk of developing gout or treat existing gout,” said study co-leader Milica Blagojevic-Bucknall. She said more research is needed to investigate the effect of CPAP treatment in people with gout. Blagojevic-Bucknall is a lecturer at Keele University. More information The U.S. National Institute of Arthritis and Musculoskeletal and Skin Diseases has more on gout.
29 August 2018
WEDNESDAY, Aug. 29, 2018 (HealthDay News) — A certain type of clay appears effective against disease-causing bacteria in wounds, including some that are antibiotic-resistant, researchers say. In some cultures, wet clay or mud is used as a skin treatment or poultice, and the use of mud as medicine stretches far back in human history. “We showed that this reduced iron-bearing clay can kill some strains of bacteria under the laboratory conditions used, including bacteria grown as biofilms, which can be particularly challenging to treat,” said study senior author Dr. Robin Patel. She is a clinical microbiologist and infectious diseases specialist at the Mayo Clinic in Rochester, Minn. Biofilms, which occur when bacteria develop a film or protective coating that increases their resistance to antibiotics, appear in two-thirds of the infections seen by doctors, the study authors explained in a Mayo Clinic news release. According to Enriqueta Barrera, program director of the National Science Foundation’s Division of Earth Sciences, “This study is an important advance in understanding how clays, specifically blue clay from Oregon, have shown medicinal properties by attaching to pathogenic bacteria.” The foundation funded the study, which was published online recently in the International Journal of Antimicrobial Agents. The study authors noted that the findings are preliminary. They also cautioned that not all types of clay are beneficial. Some may help bacteria grow. More information DermNet NZ has more on wound infections.
28 August 2018
TUESDAY, Aug. 28, 2018 (HealthDay News) — Those full-body scanners used for security checks in airports, train stations and some public buildings are safe for people with implanted heart pacemakers and defibrillators, a new study found. Nearly 4 million people worldwide have these types of devices, but it’s been unclear whether their functioning is affected by body scanners, the study authors said. The scanners emit millimeter waves that bounce off the skin and create an image of the body and any hidden objects, explained the authors, who presented their findings this week at the annual meeting of the European Society of Cardiology, in Munich, Germany. The study included 300 patients in Germany with a pacemaker, implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device. The functioning of the devices was monitored as the patients underwent a full-body security scan in a hospital. “We found no evidence of electromagnetic interference or device malfunction with the full-body scanner we tested and can conclude that scanning is safe for patients with implanted cardiac devices,” said study author Dr. Carsten Lennerz, of the German Heart Centre Munich, and the German Center for Cardiovascular Research. “This may be because cardiac devices filter out high-frequency signals such as millimeter waves, the waves hardly penetrate the body at all, and the scan time is very short [usually around 100 milliseconds],” he said in a society news release. Lennerz said a multicenter survey of 800 patients with cardiac devices found that 80 percent worry about the safety of security body scanners and would refuse a scan, preferring a manual check instead. “This takes more time and requires giving medical details to security staff,” he said. “The study suggests that millimeter wave body scanners pose no threat to patients with pacemakers, ICDs and CRT devices, and there is no need for specific protocols or restrictions on their use,” Lennerz concluded. The society’s meeting concludes Wednesday. Research presented at medical meetings is usually viewed as preliminary if it hasn’t been published in a peer-reviewed journal. More information The American Heart Association has more on implantable medical devices.
27 August 2018
MONDAY, Aug. 27, 2018 (HealthDay News) — A furrowed brow could be a red flag for your heart health, a new French study suggests. People who have more deep forehead wrinkles than is typical for their age might have a higher risk of dying from heart disease, researchers found. Those with the deepest wrinkles on their brow had nearly 10 times the death risk from heart problems as those with no wrinkles at all, even after adjusting for other risk factors, researchers report. “The higher your wrinkle score, the more your cardiovascular mortality risk increases,” said lead researcher Yolande Esquirol, an associate professor of occupational health at the Centre Hospitalier Universitaire de Toulouse in France. But the study did not prove that forehead wrinkles cause heart risks to rise, and other heart experts remained skeptical. “I’m not so sure I would put too much on this until we have more evidence,” said Dr. Roxana Mehran, a professor of cardiology and director of interventional cardiovascular research and clinical trials with the Icahn School of Medicine at Mount Sinai in New York City. “To imagine this could be a risk factor for cardiovascular mortality, it would need further investigation, I think.” The French researchers explored forehead wrinkles as a marker for heart health problems “because it’s so simple and visual,” Esquirol said. “Just looking at a person’s face could sound an alarm, then we could give advice to lower risk.” The research team assessed the forehead wrinkles of about 3,200 working adults and then followed them for 20 years. The people were 32, 42, 52 or 62 at the beginning of the study. Each person was assigned a “wrinkle score” from zero to 3. A score of zero meant no wrinkles, while a score of 3 meant the person had numerous deep wrinkles. People with initial wrinkle scores of 2 and 3 had 9.6 times the heart-related death risk of people who had wrinkle scores of zero, after accounting for other risk factors, the study found. People with a wrinkle score of 1 were more than five times more likely to die of heart problems than those without wrinkles, the researchers added. The other risk factors included in the analysis were age, gender, education, smoking status, blood pressure, heart rate, diabetes and cholesterol levels. The researchers presented the findings Sunday at the European Society of Cardiology’s annual meeting, in Munich, Germany. They said they don’t know why forehead wrinkles might be linked to heart disease, but they said it could be due to hardening of the arteries (atherosclerosis). Wrinkle formation and hardening of the arteries both involve changes in collagen protein and oxidative stress, the researchers explained. Blood vessels in the forehead are so small they may be more sensitive to plaque build-up, meaning wrinkles could be one of the early signs of vessel aging and hardening. It also could be that hard-charging people who regularly make the sort of faces that promote forehead wrinkles — frowns of worry, stress or anger — are somehow putting a greater strain on their heart, Mehran said. “We think of wrinkles as a cosmetic issue. It would be interesting if they really portray more about a person and the stresses they have, and whether there is a correlation between that and cardiovascular disease,” Mehran said. “This is intriguing and we need to explore it further.” Dr. Satjit Bhusri, a cardiologist with Lenox Hill Hospital in New York City, noted that “no specific biochemical relationships between forehead wrinkles and heart disease were identified. “We are continually finding associations with heart disease and patient profiles, but in the end it comes down to metabolic risk factors that don’t unfortunately unmask themselves visually in our patients,” Bhusri said. It’s possible that the models used by the researchers did not account for all of the effects of aging and smoking, or for all potential risk factors, said Donna Arnett, dean of the University of Kentucky’s College of Public Health. “I would want to see these findings replicated,” Arnett said. Esquirol said that although the study results do need to be confirmed by other researchers, doctors could start checking people’s foreheads now as a potential warning sign of heart health. “It doesn’t cost anything and there is no risk,” Esquirol said in a meeting press release. People concerned about their heart health should learn their numbers for cholesterol, blood pressure, blood sugar and body mass index, and “get treatment if your risk factors or elevated,” Arnett said. Eating right and exercising will also help. Research presented at meetings is considered preliminary until published in a peer-reviewed journal. More information The American Heart Association has more about heart risk factors.
23 August 2018
THURSDAY, Aug. 23, 2018 (HealthDay News) — A combination of two drugs that work with the immune system can help beat back melanoma that has moved to the brain, an early clinical trial has found. The study included 94 patients with advanced melanoma that had invaded the brain. All were treated with two “immunotherapy” drugs — Opdivo (nivolumab) and Yervoy (ipilimumab) — which help the immune system find and destroy tumors. Overall, 57 percent of the patients saw their brain tumors disappear, shrink or remain stable for at least six months. For most, the responses were still evident at their latest follow-up, at the 14-month mark. And after one year, more than 80 percent of all patients were still alive. “That’s really tremendous,” said lead researcher Dr. Hussein Tawbi, of the University of Texas M.D. Anderson Cancer Center in Houston. “Without treatment, that rate would be about 20 percent.” Experts said the findings represent another step forward against advanced melanoma, the deadliest form of skin cancer. Once melanoma spreads to distant sites in the body, the prognosis has traditionally been grim. When it infiltrates the brain, the typical life expectancy has hovered around four to five months, according to Tawbi. But in recent years, several new drugs have been approved to fight advanced melanoma. They include Opdivo and Yervoy, which are already used in combination. The drugs belong to a group of immunotherapies called checkpoint inhibitors. They essentially free up immune-system T-cells to seek and destroy tumor cells. But major trials of the drugs, Tawbi said, have excluded patients with brain metastases (melanoma that has spread to the brain). Right now, he said, the typical treatment for those patients is surgery to remove the tumors, if possible, as well as radiation. Then they might receive immunotherapy drugs. Tawbi’s team took a different approach: They used Opdivo and Yervoy as a first-time treatment for patients with brain metastases that were discovered during MRI scans. All received infusions of both drugs every three weeks, for up to four doses. After that, they continued with Opdivo infusions every two weeks, until their cancer progressed or the side effects became too toxic. Opdivo maker Bristol Myers-Squibb partially funded the trial. “Our first concern was whether it would be safe,” Tawbi said. One worry was that if T-cells flooded the brain to attack the cancer, it would cause dangerous brain inflammation. But, Tawbi said, the side effects were similar to what’s seen in melanoma patients without brain metastases. Most often, that meant fatigue, diarrhea, nausea and increases in liver enzymes that can indicate liver damage. One patient died of a heart complication blamed on the treatment. And 20 percent went off the drugs because of severe side effects. As for the benefits, 26 percent of patients saw their brain tumors disappear. Tumors shrank in another 30 percent, and two patients remained stable for at least six months. The overall survival rate at one year was 81.5 percent. “That’s exactly what you’d expect to see in patients without brain metastases,” said Dr. Mario Sznol. Sznol is a melanoma expert with the American Society of Clinical Oncology, and co-directs the cancer immunology program at Yale Cancer Center in New Haven, Conn. He said the findings suggest that many patients with brain metastases can skip radiation — and its side effects — and go straight to immunotherapy. That’s not true of all patients, stressed Sznol, who was not involved with the study. The trial did not include people with large brain tumors, for example — which may require surgery and radiation first. The immunotherapy drugs do have a high rate of side effects, Sznol noted, but those problems are usually medically manageable. The drugs are also very pricey: The list price for the first year of therapy with both tops $250,000. But on balance, Sznol said, “I think the risk-benefit ratio falls in favor of treatment.” A couple of small trials have tested the effects of Opdivo or Yervoy alone in patients with brain metastases, but only about one-quarter responded, according to Tawbi. So, he said, the combination appears more effective. Sznol said the findings offer a hopeful message to patients. “It’s becoming a myth that melanoma patients with brain metastases will do poorly,” he said. “Some will. But that’s not necessarily the case anymore.” The study was published Aug. 23 in the New England Journal of Medicine. More information The American Society of Clinical Oncology has more on immunotherapy for melanoma.
22 August 2018
WEDNESDAY, Aug. 22, 2018 (HealthDay News) — Many people with spinal cord injuries suffer the loss of bladder control, but a small new study shows that stimulation of the lower spine might help them regain some of that control. The study included five male patients. For four months, they received 15 minutes a week of noninvasive, painless lower spinal cord stimulation conducted through the skin using a magnetic device. After four sessions, the patients saw measurable improvements in bladder control, the researchers said. “All five of the men regained the ability to urinate on their own during stimulation,” said principal investigator Daniel Lu. He’s an associate professor of neurosurgery at the University of California, Los Angeles. “In one case, the patient was able to stop using a catheter and empty his bladder several times a day — up to two weeks after his last treatment,” Lu added in a university news release. The other four patients still had to use a catheter at least once each day, but that was much less than the average of more than six times a day before treatment, according to the report. “Most spinal cord injuries are not anatomically complete; the spinal cord retains a weak, residual connection with the brain. We are restoring bladder function by amplifying these faint signals and enhancing the spinal circuits’ ability to respond to them,” Lu explained. “We were excited to see a positive effect in all five patients after only four sessions of mild magnetic stimulation,” he said. “The benefit gradually wore off over two weeks, suggesting that the spinal cord’s neural circuitry retains a ‘memory’ of the treatment.” The study was published Aug. 22 in the journal Scientific Reports. More than 80 percent of the 250,000 Americans with a spinal cord injury lose the ability to urinate at will after their injury and rely on a catheter to drain urine. But long-term catheter use is inconvenient and can pose infection risks. Lu and his team plan to conduct another larger study to learn more about how magnetic stimulation improves bladder control in spinal cord injury patients. The magnetic stimulation device is approved by the U.S. Food and Drug Administration for human use, but this type of use is experimental. More information The U.S. National Institute of Neurological Disorders and Stroke has more on spinal cord injury.
20 August 2018
MONDAY, Aug. 20, 2018 (HealthDay News) — A maple leaf extract may help prevent wrinkles, scientists say. In a new study, researchers found that certain compounds in maple leaves block the release of an enzyme called elastase, which breaks down a protein called elastin as people age. Elastin helps maintain skin elasticity. Previous work by the same University of Rhode Island researchers found that these same compounds in maple leaves might help protect skin from inflammation and lighten dark spots, such as freckles or age spots. “You could imagine that these extracts might tighten up human skin like a plant-based Botox, though they would be a topical application, not an injected toxin,” principal investigator Navindra Seeram said in an American Chemical Society (ACS) news release. Such products would provide a new option for people who want natural, plant-based skincare products, and also might provide economic benefits in the United States and Canada, the researchers said. “Many botanical ingredients traditionally come from China, India and the Mediterranean, but the sugar maple and the red maple only grow in eastern North America,” Seeram said. Woodlot owners who currently only harvest sap from the maple trees could use the leaves as an additional source of income. The process would be sustainable because the leaves could be collected during normal pruning or when they fall from the trees in autumn, Seeram said. The team’s research is continuing, and it’s also formulating the findings into a patent-pending product. The study findings are scheduled for presentation Monday at the annual meeting of the ACS, in Boston. Research presented at meetings should be considered preliminary until published in a peer-reviewed journal. More information The U.S. National Institute on Aging has more about skin care.