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Ninlaro Approved for Multiple Myeloma

Ninlaro (ixazomib), in combination with two other drugs, has been approved by the U.S. Food and Drug Administration to treat people with multiple myeloma who have had at least one prior treatment with a different therapy.

Multiple myeloma is a type of cancer that forms in infection-fighting white blood cells produced in bone marrow. Symptoms include a weakened immune system and bone and kidney problems.

Ninlaro, from a class of drugs called proteasome inhibitors, is designed to block enzymes that spur the growth and survival of multiple myeloma cells, the FDA said Friday in a news release.

Almost 27,000 cases of multiple myeloma will be diagnosed in the United States this year, and more than 11,000 people are projected to die from it, the FDA said, citing the National Cancer Institute.

Ninlaro is approved in combination with another multiple myeloma drug, Revlimid (lenalidomide), and the corticosteroid drug dexamethasone. The drug combination was evaluated in clinical studies involving 722 people. Those who took Ninlaro in tandem with the other two drugs lived for more than 20 months without their disease progressing, compared with about 14 months among those who took a placebo and the other two drugs, the FDA said.

Side effects of Ninlaro included diarrhea, constipation, low blood platelets, nerve damage of the hands and feet, nausea/vomiting and back pain.

Ninlaro, the third multiple myeloma drug approved by the FDA this year, is produced by the Japanese drugmaker Takeda Pharmaceuticals.

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Exercise Can Reduce Heart Failure Risk, No Matter Your Age

Starting to exercise later in life can still reduce your risk of heart failure, and even modest increases in activity could provide some protection, researchers say.

“Our findings suggest that when it comes to exercise and heart failure, the better-later-than-never axiom rings particularly true, and that even small boosts in activity can cut risk,” senior investigator Dr. Chiadi Ndumele said in a Johns Hopkins University School of Medicine news release. He is a preventive cardiologist and assistant professor of medicine at the medical school

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The researchers studied the exercise habits of about 11,000 American men and women in a 20-year government study on aging and heart disease. All were between the ages of 45 and 64. None had heart disease at the start of the study. Activity levels were assessed on two consecutive visits over six years.

Compared to those who were inactive at both visits, people who met or exceeded recommended physical activity levels of 150 minutes of moderate exercise or 75 minutes of vigorous exercise per week at both visits were 33 percent less likely to develop heart failure, the study found. Those who were consistently getting modest amounts of exercise — less than 149 minutes of moderate activity or less than 74 minutes of vigorous activity a week — had a 20 percent lower risk, the study revealed.

But the researchers also found that inactive people who got moving to reach recommended physical activity levels at some point during the study reduced their risk of heart failure — by 22 percent. Inactive folks who increased their activity levels to about 30 minutes of walking four times a week reduced their risk by 12 percent, the researchers said.

The study was presented earlier this month at the American Heart Association’s annual meeting in Orlando, Fla. Findings presented at meetings are generally viewed as preliminary until published in a peer-reviewed journal.

Study first author Dr. Roberta Florido, a cardiology fellow at Hopkins, said in the news release, “Many people get discouraged if they don’t have the time or ability to exercise vigorously, but our findings demonstrate that every little bit of movement matters and that picking up exercise later in life is decidedly better than not moving at all.”

About 5 million Americans and 23 million people worldwide have heart failure, the researchers said.

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Yoga May Boost Quality of Life for Prostate Cancer Patients

Yoga may benefit men who are undergoing radiation therapy for prostate cancer, according to a small study.

Many such patients experience side effects, including fatigue, erectile dysfunction, urinary incontinence and a decline in their quality of life, the researchers said.

The new study included 27 men who attended 75-minute yoga classes twice a week. These patients saw their quality of life and side effects remain stable throughout their radiation treatment.

“Data have consistently shown declines in these important measures among prostate cancer patients undergoing cancer therapy without any structured fitness interventions, so the stable scores seen with our yoga program are really good news,” Dr. Neha Vapiwala, an associate professor in the radiation oncology department of the Perelman School of Medicine at the University of Pennsylvania, said in a university news release.

Yoga may help reduce cancer- and treatment-related fatigue, the study authors suggested. It may also strengthen pelvic floor muscles and increase blood flow, which could improve erectile dysfunction and urinary incontinence

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“There may also be a psychosocial benefit that derives from participation in a group fitness activity that incorporates meditation and promotes overall healthiness. And all of this ultimately improves general quality of life,” Vapiwala added.

The study was presented this week at the Society of Integrative Oncology’s international conference in Boston. Research presented at meetings should be viewed as preliminary until published in a peer-reviewed journal.

Previous research has suggested that yoga may benefit cancer patients, but those studies have focused mainly on breast cancer.

Nearly 240,000 American men are diagnosed with prostate cancer each year, according to the American Cancer Society, which funded the study.

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Childhood Cancer Survivors May Suffer Physically, Mentally Decades Later

Childhood cancer survivors can have poor mental and physical health as adults, according to two new studies.

These health problems may be related to some of the toxic medications needed to treat cancer, experts say.

“We are doing a lot better at curing childhood cancers, but there are a lot of late effects of treatment that need to be looked at,” said Dr. Karen Effinger, a pediatrics instructor at Stanford School of Medicine. Because they are so young when treated, children and teens with cancer are the most vulnerable to long-term effects of treatment, she noted.

In one study, Danish researchers found that cancer survivors were more likely to be hospitalized as adults. In the other, kids who survived bone cancer were more likely to have poor reading and thinking skills, investigators found.

Both studies were published Nov. 19 online in JAMA Oncology.header-img_1

“Survivors after cancer in adolescence and young adulthood should be knowledgeable about their increased risk for health problems related to their treatment,” said Kathrine Rugbjerg, of the Danish Cancer Society Research Center in Copenhagen.

“Increased attention to symptoms that might indicate a disease and being treated early might prevent a disease from developing,” added Rugbjerg. She led a study of the hospitalization risk for more than 33,000 young cancer survivors who were diagnosed from 1943 through 2004.

Survivors of leukemia, brain cancer or Hodgkin lymphoma had the highest risk of hospitalization — roughly double — up to 34 years after their battle with cancer, the study found.

Overall, the researchers identified more than 53,000 hospitalizations for at least one of 97 diseases, including cancer; heart, lung or endocrine diseases; nervous system disorders, and infectious diseases, she said.

In the other and smaller study, lead researcher Kevin Krull, of St. Jude Children’s Research Hospital in Memphis, and colleagues examined the mental abilities of survivors of childhood osteosarcoma, a type of bone cancer.

These cancer survivors had lower scores in reading, attention, memory and the speed at which their brain processes information, Krull said.

But a powerful drug used to treat osteosarcoma — methotrexate — doesn’t seem to have caused that mental decline, the study concluded.

The study included 80 patients with an average age of nearly 39, whose cancer was diagnosed almost 25 years earlier. The researchers compared them with 39 people who had not had cancer.

Krull said that although methotrexate is linked to brain problems when given in high doses, the survivors’ mental impairment appeared related to current health conditions, not that drug.

But these patients also reported having heart problems, he said. “These problems could result from another type of drug these patients received, called anthracyclines, which can damage the heart, Krull said.

“These heart problems are producing reduced blood flow to the brain,” he said. “These heart difficulties seem to be causing the mental problems.”

Whatever the cause, the mental problems have real-world consequences, Krull said. Survivors with mental problems were less likely to graduate college. They were also almost four times more likely to be unemployed and three times more likely to earn less than $40,000 a year, he said.

“Care of the cancer patient doesn’t stop with the cancer,” Krull said. “We have to continue to monitor these chronic health conditions because they can impact brain growth and development and affect daily life skills.”

Effinger, who co-authored of an accompanying editorial in the journal, called for more study on the long-term consequences of cancer treatment in kids.

“We know that there are late effects that come from treatment, and we need to figure out what we can do to reverse those effects and protect patients and give them an improved quality of life,” she said.

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Coffee Drinkers May Live Longer

Coffee lovers may live longer than those who don’t imbibe — with lower risks of early death from heart disease and neurological conditions such as Parkinson’s disease, a large U.S. study finds.

Researchers said the study, published online Nov. 16 in Circulation, adds to a large body of evidence on the good side of coffee.

People often think of coffee-drinking as a bad habit that they need to break, said study leader Dr. Frank Hu, a professor of nutrition and epidemiology at Harvard School of Public Health in Boston.

But, Hu said, many studies have linked moderate coffee intake to lower risks of developing various diseases — from heart disease and diabetes, to liver cancer, to neurological diseases such as Parkinson’s, multiple sclerosis and Alzheimer’s.

His team’s study, funded by the U.S. National Institutes of Health, adds another layer of evidence. It found that coffee drinkers were not only less likely to develop certain diseases — they also tended to live longer.

Over 30 years, nonsmokers who drank three to five cups of coffee a day were 15 percent less likely to die of any cause, versus nondrinkers. Specifically, they had lower rates of death from heart disease, stroke, neurological conditions and suicide.

Both regular coffee and decaf were linked to longer survival, the study found.

None of that proves coffee, itself, extends people’s lives or directly protects against certain diseases, Hu said. Other factors might explain the connection.

But, Hu added, his team did account for many of those factors. And the coffee benefit remained.

The findings are based on more than 200,000 U.S. doctors, nurses and other health professionals who were surveyed repeatedly over almost three decades. During that time, almost 32,000 study participants died.

It turned out that people who drank one to five cups of coffee at the outset had lower odds of dying during the study period when other lifestyle habits and certain health problems, such as high blood pressure and diabetes, were taken into account.

The relationship grew stronger when the researchers looked only at nonsmokers: Those who drank three to five cups of coffee a day were 15 percent less likely to die during the study period, compared with adults who didn’t drink coffee. Lower risks were even seen among the heaviest coffee drinkers (more than five cups a day), who had a 12 percent lower death risk than nondrinkers.

“The body of evidence does suggest coffee can fit into a healthy lifestyle,” Hu said.

That evidence, Hu noted, has already been incorporated into the latest U.S. dietary guidelines, which say that a healthy diet can include up to three to five cups of coffee a day.

But overall lifestyle is key, Hu said. That is, there’s a difference between a person who gets little sleep, then uses coffee to function during the day, and a person who sleeps well, exercises, and eats a balanced diet that includes some coffee.

Alice Lichtenstein, a spokesperson for the American Heart Association, agreed.

“This doesn’t mean you should start drinking coffee in the hopes of getting health benefits,” said Lichtenstein, who is also a professor of nutrition science and policy at Tufts University in Boston.

But, she added, the new findings build on years of evidence that coffee is not the bad guy many believe it is. “There’s this lingering idea that coffee must be bad for you because it’s enjoyable,” Lichtenstein said. “It’s almost like we’ve been trying to find something wrong with it.”

There are caveats, though. “You do need to be careful about what you’re putting in your coffee,” Lichtenstein pointed out. Some milk is fine, she said, but watch the sugar and heavy cream.

And why would coffee be related to health benefits? It’s not clear from this study, Hu said, but other research has suggested that compounds in coffee can reduce inflammation, act as antioxidants, and improve blood sugar regulation, among other things.

Also, when it comes to some neurological conditions, such as Parkinson’s disease, Hu said, there’s evidence that caffeine offers benefits.

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study suggests ,Falls,Fights Cause Most Serious Eye Injuries

Falls and fights are the leading causes of eye injuries that land people in the hospital, a new study finds.

Also, the cost of treating such injuries is going up. The analysis of data from nearly 47,000 people hospitalized for eye injuries between 2002 and 2011 showed that treatment costs rose 62 percent during that time and is now more than $20,000 per injury.

“While we have some clues, we still can’t be certain why it’s more expensive to get treated for an eye injury now than before,” wrote lead researcher Dr. Christina Prescott, an ophthalmology professor at Johns Hopkins University in Baltimore.

“It could be related to drug prices or administrative costs. Either way, it’s clear we need more targeted interventions to help reduce these types of injuries, many of which are preventable,” she added.

Overall, fighting and assaults caused the second highest number of eye injuries, accounting for nearly 8,000 hospitalizations. However, this was the most common cause of eye injuries among those aged 10 to 59.

Among children aged 10 and younger, the leading cause of eye injury was accidentally being hit by a person or object, followed by car crashes and accidentally being hit, pierced or cut by sharp objects such as scissors.

Research presented at meetings is considered preliminary until published in a peer-reviewed medical journal.

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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.