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Breast-Feeding may Reduce Risk of retinopathy of prematurity

Breast-feeding a premature infant may help reduce the risk of a serious eye problem known as retinopathy of prematurity (ROP), new research suggests.

The researchers said that when babies were exclusively fed breast milk, the risk of any-stage ROP appeared to drop by about 75 percent. And the risk of severe ROP seemed to be reduced by 90 percent, the researchers added.Retinopathy-of-Prematurity-Lawsuit-lawyer-attorney

“Human milk feeding potentially plays a strong role in protecting very preterm newborns from any-stage ROP and severe ROP,” the international team of study authors wrote.

Retinopathy of prematurity causes blood vessels to grow in the retina, the light-sensitive tissue in the back of the eye. When the vessels grow, they can cause the retina to detach, destroying vision, according to the U.S. National Eye Institute.

For the study, researchers from China, Canada and the United Kingdom reanalyzed the results of five published studies on ROP. The studies included more than 2,200 preterm infants, comparing how often babies had been fed human milk or formula, and whether or not they developed ROP.

However, the new analysis only showed an association between breast milk and a reduced risk of ROP. It did not prove a cause-and-effect relationship due to the study’s design.

Results of the study were published online Nov. 16 in Pediatrics.

Extremely preterm babies are most at risk of ROP. In the United States, 59 percent of babies born at 22 to 28 weeks have the disorder, said study researcher Dr. Chao Chen, a neonatologist at Children’s Hospital of Fudan University, in Shanghai. He added that in China, a previous study showed the incidence of ROP was 50 percent in infants with a birth weight under 1,000 grams (2.2 pounds).

ROP “has become a leading cause of childhood blindness in recent time,” Chen said. “In general, there are more ROP cases in developed countries, but more severe cases and higher rates of blindness in developing countries.”

The greater incidence of ROP is likely due to the increasing survival rate of very preterm babies in developed countries, according to Chen. In developing countries, preterm babies are less likely to survive. When they do, the screening and treatments are not as good, Chen said, so blindness may be more likely.

Babies in the studies had a range of gestational ages, from 26 to about 30 weeks. Their weights ranged from about 1.7 pounds to about 3 pounds. No information was given about how long the breast-feeding continued.

In re-evaluating the studies, Chen’s team found that breast-feeding in any amount appeared to reduce the risk of ROP. And it appeared that the more breast milk, the better. Exclusive breast-feeding seemed to drop the odds of ROP by 75 percent compared to exclusive formula use. And any breast-feeding appeared to reduce the odds of the serious eye disease by 46 percent, the research showed.

How might human milk offer protection from the eye disorder? The antioxidants in human milk may help, Chen said. Human milk also has immune-protective properties, the researchers said. Breast-feeding also seems to help prevent two conditions known as sepsis and necrotizing enterocolitis that may require oxygen therapy, which has also been linked to a higher risk of ROP, the study authors said.

Dr. Adolfo Llanos, a neonatologist at Nicklaus Children’s Hospital in Miami, who was not involved with the new study, said the “quality of this analysis is very good. It’s reassuring to see the benefit we see with breast milk.”

He said breast milk may help by reducing inflammation in the body. “Preemies don’t regulate inflammation in their bodies well,” he said.

The takeaway from this study, Llanos said, is to breast-feed as long as possible, if possible.

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FDA Approves Narcan Nasal Spray

Today the U.S. Food and Drug Administration approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose. Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illegal drug heroin.

Drug overdose deaths, driven largely by prescription drug overdoses, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. In 2013, the Centers for Disease Control and Prevention reported the number of drug overdose deaths had steadily increased for more than a decade. When someone overdoses on an opioid, it can be difficult to awaken the person, and breathing may become shallow or stop – leading to death if there is no medical intervention. If naloxone is administered quickly, it can counter the overdose effects, usually within two minutes.

“Combating the opioid abuse epidemic is a top priority for the FDA,” said Stephen Ostroff, M.D., acting commissioner, Food and Drug Administration. “We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.”

Until this approval, naloxone was only approved in injectable forms(most commonly delivered by syringe or auto-injector. Many first responders and primary caregivers, however, feel a nasal spray formulation of naloxone is easier to deliver, and eliminates the risk of a contaminated needle stick. As a result, there has been widespread use of unapproved naloxone kits that combine an injectable formulation of naloxone with an atomizer that can deliver naloxone nasally. Now, people have access to an FDA-approved product for which the drug and its delivery device have met the FDA’s high standards for safety, efficacy and quality.

Narcan nasal spray does not require assembly and delivers a consistent, measured dose when used as directed. This prescription product can be used on adults or children and is easily administered by anyone, even those without medical training. The drug is sprayed into one nostril while the patient is lying on his or her back, and can be repeated if necessary. However, it is important to note that it is not a substitute for immediate medical care, and the person administering Narcan nasal spray should seek further immediate medical attention on the patient’s behalf.

The FDA granted fast-track designation and priority review for Narcan nasal spray. Fast track is a process designed to facilitate development and expedite review of drugs intended to treat serious conditions and that demonstrate the potential to address an unmet medical need. The agency’s priority review program provides for an expedited review of drugs that offer a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. Narcan nasal spray is being approved in less than four months, significantly ahead of the product’s prescription drug user fee goal date of January 20, 2016.

In clinical trials conducted to support the approval of Narcan nasal spray, administering the drug in one nostril delivered approximately the same levels or higher of naloxone as a single dose of an FDA-approved naloxone intramuscular injection, and achieved these levels in approximately the same time frame.

“We heard the public call for this new route of administration, and we are happy to have been able to move so quickly on a product we are confident will deliver consistently adequate levels of the medication – a critical attribute for this emergency life-saving drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The National Institute on Drug Abuse played a critical role in the development of Narcan nasal spray as well, forming a public-private partnership by designing and conducting the clinical trials required to determine that the intranasal formulation delivered naloxone as quickly and as effectively as an injection. NIDA then worked with its private sector partners to obtain FDA approval.

“This easy-to-use intranasal formulation will no doubt save many lives,” said Nora Volkow, M.D., director, National Institute on Drug Abuse at the National Institutes of Health. “While prevention is the ultimate goal, the drug’s successful development illustrates how public/private scientific partnerships can play an important role in responding to a national crisis right now.”

Increasing access to and the use of naloxone is part of the targeted strategy that Health and Human Services Secretary Sylvia M. Burwell put forward in March to address the opioid epidemic and save lives. In July, addiction and advocacy groups called for expanded availability of naloxone during an FDA-sponsored public workshop exploring the uptake and use of the drug.

The use of Narcan nasal spray in patients who are opioid dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

 

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Brain Differences May Explain Why hallucination occurs in Schizophrenia

Researchers believe they’ve identified brain structure differences that increase the risk of hallucinations in people with schizophrenia.

“Hallucinations are very complex phenomena that are a hallmark of mental illness and, in different forms, are also quite common across the general population,” said study first author Jane Garrison, from the University of Cambridge in England. “There is likely to be more than one explanation for why they arise, but this finding seems to help explain why some people experience things that are not actually real,” she said in a university news release.

The researchers analyzed brain scans of schizophrenia patients and people without the mental illness. They found that schizophrenia patients with hallucinations had structural differences in a certain part of the brain compared to patients who did not hallucinate and people without the disease.

Specifically, schizophrenia patients with hallucinations had a shorter paracingulate sulcus (PCS), a fold near the front of the brain. A 1-centimeter (0.4-inch) reduction in the fold’s length was associated with a nearly 20 percent increased risk of hallucinations. The effect held for both auditory and visual hallucinations.

The paracingulate sulcus is one of the last structural folds to develop in the brain before birth, and varies in size between people, according to background information with the study, published Nov. 17 in the journal Nature Communications.

Study leader Jon Simons, a neuroscientist from Cambridge’s psychology department, said, “Schizophrenia is a complex spectrum of conditions that is associated with many differences throughout the brain, so it can be difficult to make specific links between brain areas and the symptoms that are often observed.

“By comparing brain structure in a large number of people diagnosed with schizophrenia with and without the experience of hallucinations, we have been able to identify a particular brain region that seems to be associated with a key symptom of the disorder,” he explained in the news release.

Garrison, also a member of the psychology department, said the investigators think “PCS is involved in brain networks that help us recognize information that has been generated ourselves.” People with a shorter paracingulate sulcus “seem less able to distinguish the origin of such information, and appear more likely to experience it as having been generated externally,” she said.

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More Gluten Before Age 2 have a greater risk of developing celiac disease

Children who eat more foods with gluten before they’re 2 years old have a greater risk of developing celiac disease if they carry a genetic risk factor for the condition, new research suggests.

“This finding offers insight into why some, but not all, children at genetic risk develop celiac disease,” lead study author Carin Andren Aronsson, from the department of clinical sciences at Lund University in Sweden, said in a prepared statement.

“Our study provides convincing evidence that the amount of gluten ingested at an early age plays a role in disease course,” Aronsson added.

It’s important to note, however, that while the study found an association between eating more gluten early in life and celiac disease, it wasn’t designed to prove a cause-and-effect relationship.

The findings were published online in the journal Clinical Gastroenterology and Hepatology. The study was funded by the U.S. National Institutes of Health.

About 1 percent to 3 percent of the world’s population has celiac disease, according to background information in the report. Celiac disease is an autoimmune condition that causes damage to the small intestine when someone with the disease eats foods containing gluten, according to the Celiac Disease Foundation. Gluten is a protein found in grains, such as wheat, rye and barley.

For the study, the researchers matched 146 children with celiac disease to 436 children who didn’t have the disease. All of the children were from Sweden. Each group shared the same age, gender and specific combination of genetic risk factors. Approximately half of white people have genetic risk factors for celiac disease, the study authors noted.

The children in the study were between 15 months old and 8 years old when they were diagnosed with celiac disease.

The children’s gluten intake was tracked at 9, 12, 18 and 24 months of age. Babies in Sweden tend to consume more gluten-containing foods than they do in other countries, the study authors pointed out. Foods with gluten are also often introduced into a baby’s diet sooner than tends to occur in other countries, the researchers said.

The researchers found that children who consumed more than 5 grams of gluten per day before age 2 had a higher risk of celiac disease than those who consumed less than 3.4 grams of gluten per day.

Dr. Joseph Levy is a professor of pediatrics and director of special projects in the division of pediatric gastroenterology at NYU Langone Medical Center in New York City. He said, “If you are to conclude something from this study, it’s that reducing the amount of gluten in the first few years of life might reduce the risk of celiac in children who are predisposed genetically for celiac disease.” Levy was not involved with the study.

Another expert agreed.

“At this point, it’s too early to say all newborns should moderate their gluten intake. But those at the highest risk, with affected parents or siblings, may want to avoid doses higher than 5 grams per day during early life,” said Dr. Arun Swaminath, director of the inflammatory bowel disease program at Lenox Hill Hospital in New York City.

“Whether there is a ‘low but safe’ boundary isn’t clear,” Swaminath added.

But, Levy emphasized, skipping or reducing gluten for a few years is not a guarantee of escaping celiac disease.

“What this study doesn’t tell us is what happens later in life because you don’t only develop celiac disease in childhood,” Levy explained. “You can develop celiac disease at any time in life. It could occur from a trigger, such as a viral infection, or something else. So what would be very interesting is to see what happens to these cohorts of children later.”

There’s also no need for parents to rush out to test their children for the genetic risk factors for celiac disease, Levy said.

 

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Lowering Body Temperature May Help Cardiac Arrest Patients

Lowering the body temperature after someone’s heart has stopped beating may improve the odds of surviving with good brain function, a new study suggests

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In fact, patients whose body temperatures were lowered (therapeutic hypothermia) were nearly three times more likely to survive cardiac arrest, the study found. Those treated with the cold therapy were also 3.5 times more likely to have better mental function than those who didn’t receive the therapy, the researchers said.

“Our findings provide support for the idea that all unconscious post-arrest patients should receive aggressive care with therapeutic hypothermia,” said lead researcher Dr. David Gaieski, an associate professor of emergency medicine at the School of Medicine at Thomas Jefferson University in Philadelphia.

“Withholding [this treatment] does not make sense given these data and other data from other studies at many institutions around the world,” he said.

The report was published Nov. 16 online in the journal Circulation.

The body gets too little blood when the heart stops beating, or when blood flow is blocked by a blood clot or stroke, Gaieski said. In these situations, lowering the body’s temperature can help protect it, he explained.

Earlier studies have shown that the cold treatment can improve survival and brain function in people with “shockable” rhythms, such as ventricular fibrillation, the study said. Ventricular fibrillation is a condition where the lower chambers quiver, preventing the heart from pumping blood and causing cardiac arrest, the American Heart Association notes. In many of these cases the heart can be “shocked” into a normal rhythm, Gaieski said.

But there are cases of patients in cardiac arrest with “nonshockable” rhythms. This is when there is no electrical activity in the heart, or when there is electrical activity, the heart isn’t contracting and blood isn’t flowing, he explained. Currently, there aren’t a lot of hospitals using temperature-lowering therapy for patients who have a nonshockable rhythm, the researchers said.

For the study, Gaieski’s team looked at data from more than 500 patients whose hearts stopped beating between 2000 and 2013. All had nonshockable rhythms. Lowering the body’s temperature increased survival rates and brain function in these patients, the study said.

Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York City and a spokesman for the American College of Emergency Physicians, said, “This important trial demonstrates that cooling should be tried in all patients with cardiac arrest, regardless of the initial heart rhythm.”

Glatter noted that the actual number of patients who survive mentally intact remains low. But, he added, reducing the body temperature has been shown to have a positive effect on improving outcomes.

“There has been a slow adoption of this treatment from lack of understanding the benefits of this easily implemented therapy,” he said.

Glatter added that lowering body temperature doesn’t require special equipment. It can be accomplished using equipment already in every hospital, he said.

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Rectal Thermometer Remains Gold Standard for Spotting Fever

Although it’s no one’s favorite method, a rectal thermometer is the best way to determine someone’s body temperature, experts say.

Accurate body temperature readings are important because they are used to make diagnoses, check for infectious diseases, evaluate whether or not a treatment is working, and guide patient management, the study authors explained.

Rectal thermometers are considered the gold standard, the researchers said. But the accuracy of thermometers used in the mouth or under the arm (peripheral thermometers) has been unclear.

So, the researchers reviewed 75 published studies. They found that peripheral thermometers are less accurate than rectal thermometers, particularly for low-grade fevers.

The findings were published online Nov. 16 in the journal Annals of Internal Medicine.

Health care workers should use rectal thermometers when a patient’s temperature will influence diagnosis and treatment, the researchers said in a news release from the American College of Physicians.

Rectal thermometers can be used for most children and adults. When that isn’t possible, a calibrated ear thermometer (or a bladder thermometer for patients with bladder catheters) are good alternatives, according to Dr. Daniel Niven from Alberta Health Services in Canada, and colleagues.

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FDA Finalizes New Food Safety Rules

In the wake of wide-ranging outbreaks of foodborne illness, the U.S. Food and Drug Administration on Friday finalized new rules to help keep contaminated food out of American kitchens.

These food safety regulations for fruit and vegetable farms and food importers were developed as a result of the Food Safety Modernization Act of 2011

Taylor said that outbreaks caused by leafy greens, cantaloupes, cilantro and other produce underscore the need for the new requirements

“A recent outbreak of salmonella in imported cucumbers killed four Americans and sent more than 157 to the hospital,“ he said. “These outbreaks are just the kind of food safety problems today’s rules are meant to prevent.”

The establishment of regulations changes the FDA’s mission from reacting to outbreaks of foodborne illness to making the food industry responsible for preventing them, Taylor said.

The new farm rule sets requirements for water quality; employee health and hygiene; wild and domesticated animals; compost and manure; and equipment, tools and buildings, the FDA said.

Also, food importers must verify that foreign suppliers are producing foods that meet U.S. safety standards. And the suppliers’ facilities must achieve the same level of food safety as domestic farms and food facilities.

The FDA will also empower accredited independent auditors to conduct food safety inspections of foreign food facilities. In some cases, the FDA can require certification that imported food is safe.

Each year some 48 million Americans — one in six — are sickened by foodborne diseases. About 128,000 people are hospitalized and 3,000 die from contaminated food, according to the U.S. Centers for Disease Control and Prevention.

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Study suggests vitamin D deficiency may cause erectile dysfunction

Low levels of vitamin D may be associated with erectile dysfunction, a new study suggests.

Researchers analyzed data from more than 3,400 American men, age 20 and older, who did not have heart disease. Thirty percent were vitamin D deficient, which means their levels of the “sunshine vitamin” were below 20 nanograms per milliliter of blood. And 16 percent had erectile dysfunction.

Vitamin D deficiency was present in 35 percent of men with erectile dysfunction, compared with 29 percent of those without erectile dysfunction, the study found.

“Vitamin D deficiency is easy to screen for and simple to correct with lifestyle changes that include exercise, dietary changes, vitamin supplementation and modest sunlight exposure,” study lead investigator Dr. Erin Michos, an associate professor of medicine at Johns Hopkins University School of Medicine, said in a university news release.

The researchers concluded that men with vitamin D deficiency were 32 percent more likely to be impotent than those with sufficient vitamin D levels. This association held even after the study authors accounted for other factors associated with erectile dysfunction, such as drinking, smoking, diabetes, higher blood pressure, inflammation and certain medications.

The researchers emphasized that their findings are observational and don’t prove cause and effect. They said more research is needed to determine if there’s a direct link between low vitamin D levels and erectile dysfunction. If that’s the case, they said it could lead to new treatment approaches.

“Checking vitamin D levels may turn out to be a useful tool to gauge ED risk,” Michos said. “The most relevant clinical question then becomes whether correcting the deficiency could reduce risk and help restore erectile function.”

About 40 percent of men older than 40 and 70 percent of those older than 70 are unable to attain and maintain an erection, the researchers said. Vitamin D deficiency affects up to 40 percent of adult Americans, according to the U.S. Centers for Disease Control and Prevention.

The study was presented Tuesday at the American Heart Association’s annual meeting in Orlando, Fla. Research presented at meetings should be considered preliminary until it’s published in a peer-reviewed medical journal.

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Study says Medicines Last as Long in Space as Here on Earth

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Medicines don’t degrade faster in space than they do on Earth, a new study finds.

Researchers analyzed nine medications that were stocked on the International Space Station for 550 days and returned unused to Earth, where they were kept under controlled conditions for three to five months.

The medications included pain relievers, sleeping aids, antihistamines/decongestants, an anti-diarrheal and an alertness drug.

The researchers assessed whether the active ingredients and the amount of degradation in the medications met United States Pharmacopeia (USP) guidelines for viability.

One medication met the USP standards five months after its expiration date, four met the standards up to eight months after their expiration dates, and three met the standards when tested three months before their expiration dates. A dietary supplement/sleeping aid did not meet the standards when tested 11 months after its expiration date.

No unusual degradation was found in any of the medications, according to the study published online Nov. 6 in the AAPS Journal.

Until now, there has been little information about how long periods of time in space affect medications.

While the International Space Station is regularly resupplied with medications, this may not be possible on long missions to more distant locations in space, said study leader Virginia Wotring. She’s with the Center for Space Medicine and Department of Pharmacology at Baylor College of Medicine in Houston.

Researchers said further studies in this area are necessary before planning long-term space flights, such as missions to Mars.

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FDA Approves Adynovate for Hemophilia A

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The U.S. Food and Drug Administration today approved Adynovate, Antihemophilic Factor (Recombinant), PEGylated for use in adults and adolescents, aged 12 years and older, who have Hemophilia A. Adynovate is modified to last longer in the blood and potentially require less frequent injections than unmodified Antihemophilic Factor when used to reduce the frequency of bleeding.

Adynovate is approved for on-demand (as needed) treatment and control of bleeding episodes and to reduce the frequency of bleeding episodes (prophylaxis) in patients with Hemophilia A. Adynovate consists of the full-length Coagulation Factor VIII molecule (historically known as Antihemophilic Factor) linked to other molecules, known as polyethylene glycol (PEGylated). This link makes the product last longer in the patient’s blood.

“The approval of Adynovate provides an important therapeutic option for use in the care of patients with Hemophilia A and reduces the frequency of Factor VIII infusions needed to avoid bleeding,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. Hemophilia A is an inherited, sex-linked, blood-clotting disorder that primarily affects males, which is caused by defects found in the Factor VIII gene. According to the Centers for Disease Control and Prevention, Hemophilia A affects one in every 5,000 male births in the United States. Patients with hemophilia A may experience repeated episodes of serious bleeding, primarily into the joints, which can be severely damaged as a result. The safety and efficacy of Adynovate were evaluated in a clinical trial of 137 adults and adolescents aged 12 years and older, which compared the recommended routine prophylactic (preventative) treatment regimen to on-demand therapy. The trial demonstrated that Adynovate was effective in reducing the number of bleeding episodes during routine care. Additionally, Adynovate was effective in treating and controlling bleeding episodes. No safety concerns were identified during the trial. Adynovate is manufactured by Baxalta US Inc., based in Westlake Village, California.