New cancer-causing toxin found in recalled blood pressure pills

(Reuters) – U.S. health regulators said on Friday a third cancer-causing toxin was found in some blood pressure pills recalled by India’s Hetero Labs Ltd a day earlier, adding to a global recall of commonly used drugs to treat hypertension.

The U.S. Food and Drug Administration is also looking into whether these types of impurities could be found in other classes of drugs, a spokeswoman for the regulator said.

The latest toxin, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), identified in 87 lots of Hetero’s losartan potassium pills, was not found in medicines that were previously recalled by a number of drugmakers.

Most recently, the U.S. unit of Indian generic drugmaker Aurobindo Pharma Ltd expanded the recall of its hypertension medicines containing valsartan to 38 more lots due to the presence of probable carcinogen, N-nitrosodiethylamine (NDEA), the FDA said on Friday.

Global authorities have been clamping down on sales of some blood pressure medicines as they are suspected to be tainted with NDEA and another probable carcinogen N-nitrosodimethylamine (NDMA).

The drugs, including losartan, belong to a class of widely used medicines for treating high blood pressure called angiotensin II receptor blockers, or ARBs. Some generic versions of other ARBs, such as valsartan and irbesartan, have also been recalled.

The FDA said increased risk of cancer in patients exposed to the new impurity, NMBA, appeared to be the same as those exposed to NDMA, but less than the risk from NDEA.

The recalls began last year after regulators said ingredients used by Chinese manufacturer Zhejiang Huahai Pharmaceuticals Co to produce valsartan contained cancer-causing impurities.

Since then, generic drugmakers such as Mylan NV, Teva Pharmaceutical and Novartis’ Sandoz have recalled products containing the tainted ingredients.

In January, the FDA warned of the possibility of additional shortages of hypertension drugs in the United States due to the recalls.

The FDA also said it is working to develop testing methods to detect other cancer-causing impurities.

Reporting by Saumya Sibi Joseph in Bengaluru and Michael Erman in New York; Editing by Saumyadeb Chakrabarty and Dan Grebler

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Many sleepless Americans trying meditation and yoga

(This February 28 story has been refiled to use initial caps in paragraph 7 to indicate that Transcendental Meditation is a registered trademark)

FILE PHOTO: People practice yoga in Times Square as part of a Summer Solstice and International Day of Yoga celebration in New York June 21, 2015. REUTERS/Eduardo Munoz

By Lisa Rapaport

(Reuters Health) – Roughly half of U.S. adults suffer from sleep problems, and research suggests that many of them are practicing mind-body exercises like yoga and meditation that might help make it easier to get a good nights’ rest.

Mind-body medicine can include a range of health practices that combine efforts to focus the mind, control breathing and move the body in ways that promote relaxation. These practices are a key component of many forms of complementary and integrative medicine that previous studies have linked to improvements in sleep, researchers note in Sleep Medicine.

For the current study, researchers examined data from a nationally representative health survey of 26,742 adults conducted in 2017. Overall, 49 percent reported sleep troubles.

Among those with sleep problems, 30 percent of people said they practice some form of mind-body exercises. That compares to only 18 percent of the individuals without sleep problems.

Yoga was most common, practiced by about 16 percent of the entire survey population, followed by spiritual meditation at 14 percent and mindfulness meditation at 8 percent.

“There are several things that people can do to help ease sleep problems, especially if they have a psychological basis,” said Sanford Nidich, director of the Center for Social and Emotional Health at the Maharishi University of Management Research Institute in Fairfield, Iowa.

One approach with a proven track record is what’s known as Transcendental Meditation, which has been shown to ease sleep disorders with a psychological component, Nidich, who wasn’t involved in the study, said by email. Transcendental Meditation involves closing the eyes and thinking of a mantra to help conjure a state of restful alertness that can help people feel calm and less stressed.

“This can easily and effortlessly be practiced in one’s own home or office twice a day for twenty-minutes,” Nidich said.

Another approach is to get more exercise and to practice yoga daily, Nidich said. Previous research has linked both practices to improvements in sleep quantity and quality.

“Lastly, modifying one’s diet and eating the largest meal in the middle of the day when the digestive ‘fires’ are strongest rather than at night, based on traditional Ayurveda medicine, can have a profound effect on sleep quality,” Nidich advised.

In the study, people with sleep problems practiced an average of two different forms of mind-body medicine.

But less than 2 percent of the survey population practiced tai chi, which has also been shown to improve sleep, the study authors note.

People who used mind-body medicine were more likely to be under 30 years old, female, non-Hispanic white, living in the Western U.S., more highly educated and diagnosed with heart disease.

Overall, about 38 percent of the participants in the study had problems staying asleep and about 35 percent struggled to fall asleep.

About 5 percent of people with sleep problems reported getting four hours or less of rest each night, while 42 percent slept six hours or less.

Even among people who didn’t report difficulties falling or staying asleep, about 1 percent slept four hours or less and about 22 percent slept six hours or less.

The study wasn’t designed to determine whether specific practices like yoga or tai chi or meditation might be better suited to reducing insomnia or other sleep problems.

Researchers also lacked data on whether participants had been diagnosed with insomnia and whether people were practicing mind-body medicine in order to address sleep issues or for other reasons.

Study co-author Melanie Desiree Hoextermann of the University of Duisburg-Essen in Germany didn’t respond to requests for comment.

SOURCE: Sleep Medicine, online January 18, 2019.

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Too Much TV Might Dull the Aging Brain

News Picture: Too Much TV Might Dull the Aging BrainBy Dennis Thompson
HealthDay Reporter

Latest Alzheimer’s News

THURSDAY, Feb. 28, 2019 (HealthDay News) — The old saying, “TV rots your brain,” could have some validity for folks as they age.

In a new study, middle-aged people who watched television for more than 3.5 hours a day experienced a decline in their ability to remember words and language over the next six years, British researchers found.

What’s worse, it appears that the more TV you watch, the more your verbal memory will deteriorate, researchers said.

“Overall, our results suggests that adults over the age of 50 should try and ensure television viewing is balanced with other contrasting activities,” said lead researcher Daisy Fancourt. She’s a senior research fellow at University College London.

For the study, researchers relied on data from a long-term study of aging involving more than 3,600 residents of England.

Participants reported the amount of hours of TV they watched daily. They also had their thinking and reasoning skills regularly tested as part of the study.

People who watched less than 3.5 hours of TV a day didn’t seem to suffer any deterioration in their brain power, Fancourt said.

But more than that amount, people became increasingly apt to struggle with words or language in tests conducted six years later.

The decline in language skills is similar to that experienced by the poor as they age, Fancourt said.

“We already know from a number of studies that being of low socio-economic status is a risk factor for cognitive decline,” Fancourt said. “If we compare the size of association for watching television for greater than 3.5 hours a day, it has a similar-sized association with verbal memory as being in the lowest 20 percent of wealth in the country.”

The worst deficits occurred in those people who watched more than seven hours of television daily, researchers found.

While only an association was seen in the study, there are a couple of potential reasons why this might happen.

“Due to the fast-paced changes in images, sounds and action, yet the passive nature of receiving these — i.e., television does not involve interaction as gaming or using the internet does — watching television has been shown in laboratory studies to lead to a more alert, but less focused, brain,” Fancourt explained.

Some TV viewing is also stressful, and stress has been associated with a decline in brain power, she added.

The specific effect on verbal skills indicates that avid TV viewing could be replacing other activities that would be better for the brain, said Rebecca Edelmayer, director of scientific engagement at the U.S.-based Alzheimer’s Association.

“You’re spending more time not engaging with your family, your friends and having social conversations, because they’re specifically reporting a decrease in verbal recall,” Edelmayer said. “We know engagement with others in conversation is something that supports and protects verbal recall.”

People who want to protect their thinking skills need to socialize often and engage in other activities that “stretch” their brain, Edelmayer said.

In fact, a long-term study published just last week in the journal Neurology found that exercising both the brain and body during middle age may guard against dementia. Such mental exercise includes reading, playing music, sewing or painting, according to the report.

“The recommendation would always be to stretch yourself and stay as engaged as you can be, whatever the connection is,” Edelmayer said. “We’re asking you for best brain health to go outside your normal passive box.”

The new study was published Feb. 28 in the journal Scientific Reports.

Copyright © 2019 HealthDay. All rights reserved.

SOURCES: Daisy Fancourt, Ph.D., senior research fellow, University College London; Rebecca Edelmayer, Ph.D., director, scientific engagement, Alzheimer’s Association, Chicago; Feb. 28, 2019, Scientific Reports

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5 ways to help prevent colon cancer

Colorectal cancer is one of the leading cancer-related killers. It’s the third most common cancer in the U.S. and the second leading cause of death from cancer. Colorectal cancer affects all racial and ethnic groups and is most often found in people 50 and older.

Colon cancer is generally treatable when caught early enough. The best way to prevent colorectal cancer is to get screened regularly starting at age 50. There are often no signs or symptoms of colorectal cancer—that’s why it’s so important to get screened. You don’t have to do it alone—Medicare covers many preventive services including colorectal cancer screenings to help you detect and prevent colorectal cancer, and you’ll pay nothing for most of them.

March is National Colorectal Cancer Awareness Month, so this is a great time to do 5 things to stop this cancer in its tracks.

  1. Get screened
  2. Exercise
  3. Maintain a healthy weight
  4. Don’t drink too much alcohol
  5. Don’t smoke

Do what you can so you’re not one of the 145,000 Americans diagnosed with colorectal cancer this year, and let Medicare help.

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Spring into action—practice prevention

Spring is a welcome reminder of new beginnings. Longer hours of daylight, blooming flowers, and warmer weather all point to a new season, and a new reason, to practice preventive care.

Preventive services are valuable to your wellbeing, because they can help you keep from getting sick and find health problems early, when treatment works best. Taking advantage of them is a crucial step in maintaining a healthy lifestyle, and every little bit helps.

When you have Medicare, you have access to a variety of preventive tests and screenings, most at no cost to you. If you’re new to Medicare, we cover a “Welcome to Medicare” preventive visit during your first 12 months of Part B coverage. This visit includes a review of your medical and social history related to your health and education and counseling about preventive services, including certain screenings, shots, and referrals for other care, if needed. If you’ve had Part B for longer than 12 months, you can get a yearly wellness visit to develop or update a personalized prevention plan based on your current health and risk factors.

Medicare also covers screening tests for breast cancer, diabetesheart disease, obesity management, and osteoporosis, just to name a few. Check out our complete list of Medicare-covered preventive services and watch our preventive benefits video.

Start this spring by practicing preventive care, so you can you stay healthy and live longer.

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Translucent wonder material used on stadium roofs helps measure protein particles

Understanding how proteins clump together is essential in modern pharmaceuticals. When these tiny particles aggregate, they can alter the effectiveness of both vaccines and drugs, especially many of the new, popular formulations derived from monoclonal antibodies. Despite its importance, the industry has yet to find an effective, large-scale way to measure particle clumping accurately. A new reference material, released today by the National Institute of Standards and Technology (NIST), aims to solve this protein problem with help from a translucent wonder material that’s often used on stadium roofs.

Biologic drugs are being prescribed today for a wide variety of ailments and diseases, including cancer, psoriasis, colitis and rheumatoid arthritis. Unlike the conventional medicines, biologics are full of living proteins. Those proteins can clump together during manufacture, shipping, or storage. Scientists would like a way to know when that happens because such protein particles can cause unwanted immune responses, so for years, they sought to create a “reference material” that could help with quality assurance and instrument calibration.

A body’s immune system is designed to recognize viruses and bacteria that are anywhere from 10 nanometers to 10 micrometers in size. Clumps of proteins that can form in biologic drugs are often this same size, which can be problematic.

“If you put something in the body that is within that same size range, it potentially raises a red flag for the body,” explained NIST scientist Dean Ripple. “Sometimes that’s desirable. In the case of many vaccines, you intentionally make particles or add clumped particles so that the body will say, ‘Oh, I really need to pay attention to what I’ve just been injected with.’ It causes a positive immune response.”

But when working with a drug product, Ripple added, “you want to quietly sneak that into the body and not raise the immune system’s alarms. You don’t want the drug product to look like an invader.”

In both vaccines and biological drugs, being able to quickly and precisely measure the aggregations would be useful. The most popular method uses light to identify particles by measuring how they scatter or absorb a beam of light passing through the sample. A detector measures changes in beam intensity as particles in a flowing sample stream through the beam. A bigger reduction in light intensity means a bigger particle is in the sample. Another method uses a microscope that captures images of a flowing sample and automatically identifies particles in the images.

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Polystyrene spheres, made of the same material used in beach coolers and packing peanuts, are typically used to calibrate instruments, essentially helping to teach the automated machine what particles look like. The polystyrene spheres come in various sizes and are widely available. But they are extremely regular in shape, unlike protein particles, which tend to be irregular and wispy. Polystyrene also refracts, or bends, light quite strongly, while protein particles cause much weaker refraction.

A NIST team, led by Ripple, began working on solving this clumping measurement problem after the Food and Drug Administration identified it as an issue in the development of new biological drugs.

The team considered many substitutes for the spheres and beads before finding inspiration from a surprising source: the building industry, where a product called Ethylene Tetrafluoroethylene (EFTE) has become a favorite of architects who like its resilience and the way it can be beautifully backlit for aesthetic purposes. Several new sports stadiums, including the one used by the Minnesota Vikings, are clad in EFTE and are lit up with the team’s colors on game days. Ripple wondered if he could damage it in a very controlled manner that would make small particles of EFTE into a new, helpful size and shape.

“After examining the stuff, I found myself saying, let’s try to make something with this ourselves. I brought in some sandpaper usually used for hobby projects and put on some nitrile gloves and began rubbing a sample of EFTE with the paper until we had enough to play with under a microscope,” he says.

What the team found was that the sturdy, light-refractive particles became wispy and tangled in shape, very much like protein particles.

Since the initial tinkering, NIST has scaled up and formalized the production process and developed a reference material that anyone can purchase for both research and manufacturing applications. In addition, a private company is beginning large-scale manufacturing of abraded EFTE particles for use by the biopharmaceutical industry.


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