Sandoz recalls wrongly-packed TB drug batch from 5 States

Drug-maker Sandoz has been asked to recall a batch of wrongly-packaged tuberculosis (TB) drugs from the market. The incorrect packaging was first discovered in Mumbai and the recall will cover five States.

Maharashtra Food and Drug Administration (FDA) Joint Commissioner S. D. Patil said Sandoz has been asked to recall all 4D and 4D-Plus batches of the tuberculosis combination product after a Mumbai-based doctor complained that his patient suffered from stomach ache and vomiting.

“There has been a mix up in the packaging of two products (4D and 4D-Plus), and so all stocks from the private market, stockists and retailers have been recalled,” said Patil. The products have been made by a third-party manufacturer, Themis Medicare of Haridwar. The State FDA in Uttarakhand has also been alerted, he added.

A Sandoz spokesperson said that while 4D was marketed across India, “according to our records, this particular batch is restricted to the domestic private market in the five States of Gujarat, Madhya Pradesh, Maharashtra, Bihar and Chhattisgarh.”

Confirming that the third-party drug maker was Themis, the spokesperson added that as investigations were still on, more details were not being shared.

Themis representatives were not willing to comment on the development.

As a precautionary measure, Sandoz is recalling one batch of the product (No DD 4670) pending further investigation. “In addition, we are investigating a potential second fault related to 4D-Plus, also used to treat tuberculosis, and of a higher strength,” the spokesperson said.

RESISTANCE CONCERNS

Though details on the quantum of stocks recalled are not available, the FDA official clarified that the problem did not relate to all stocks. But they were being recalled “as you cannot take a chance with TB drugs”.

India faces a huge problem of resistance to tuberculosis drugs, wherein medicines become ineffective in treating patients. Resistance occurs when patients do not follow a doctor’s advice and discontinue the medicine or take it erratically.

Source: Business Line

 


CDC importing meningitis vaccine to fight Princeton outbreak

Federal health officials have agreed to import a meningitis vaccine approved in Europe and Australia but not the U.S. as officials at Princeton University consider measures to stop the spread of the disease on the Ivy League campus.

The Food and Drug Administration this week approved importing Bexsero for possible use on Princeton’s campus, said Barbara Reynolds, a spokeswoman for the Centers for Disease Control and Prevention. Princeton officials confirmed the school’s seventh case of meningitis in 2013 this week and a spokesman said trustees will discuss the issue this weekend.

No vaccine for use against the type B meningococcal bacteria which caused the cases at Princeton is available in the U.S., Reynolds said, adding that the decision to receive the vaccine would be optional if Princeton and CDC officials agree to offer it to students.

Bacterial meningitis can cause swelling of the membranes covering the brain and spinal cord. The disease is fairly rare in the United States. Those who get it develop symptoms quickly and can die in a couple of days. Survivors can suffer mental disabilities, hearing loss and paralysis.

The bacteria are spread by coughing, sneezing and kissing, and most cases occur in previously healthy children and young adults. The disease can easily spread in crowded conditions, like dorm rooms. All students living in dorms are required by state law to have a licensed meningitis vaccine, but it does not protect against type B.

The school is telling students to wash their hands, cover their coughs and not to share items such as drinking glasses and eating utensils.

Source: WGN tv

 


Mini-Kidney’ Structures Generated from Human Stem Cells for First Time

Diseases affecting the kidneys represent a major and unsolved health issue worldwide. The kidneys rarely recover function once they are damaged by disease, highlighting the urgent need for better knowledge of kidney development and physiology.

Now, a team of researchers led by scientists at the Salk Institute for Biological Studies has developed a novel platform to study kidney diseases, opening new avenues for the future application of regenerative medicine strategies to help restore kidney function.

For the first time, the Salk researchers have generated three-dimensional kidney structures from human stem cells, opening new avenues for studying the development and diseases of the kidneys and to the discovery of new drugs that target human kidney cells. The findings were reported November 17 in Nature Cell Biology.

Scientists had created precursors of kidney cells using stem cells as recently as this past summer, but the Salk team was the first to coax human stem cells into forming three-dimensional cellular structures similar to those found in our kidneys.

“Attempts to differentiate human stem cells into renal cells have had limited success,” says senior study author Juan Carlos Izpisua Belmonte, a professor in Salk’s Gene Expression Laboratory and holder of the Roger Guillemin Chair. “We have developed a simple and efficient method that allows for the differentiation of human stem cells into well-organized 3D structures of the ureteric bud (UB), which later develops into the collecting duct system.”

The Salk findings demonstrate for the first time that pluripotent stem cells (PSCs) — cells capable of differentiating into the many cells and tissue types that make up the body — can made to develop into cells similar to those found in the ureteric bud, an early developmental structure of the kidneys, and then be further differentiated into three-dimensional structures in organ cultures. UB cells form the early stages of the human urinary and reproductive organs during development and later develop into a conduit for urine drainage from the kidneys. The scientists accomplished this with both human embryonic stem cells and induced pluripotent stem cells (iPSCs), human cells from the skin that have been reprogrammed into their pluripotent state.

After generating iPSCs that demonstrated pluripotent properties and were able to differentiate into mesoderm, a germ cell layer from which the kidneys develop, the researchers made use of growth factors known to be essential during the natural development of our kidneys for the culturing of both iPSCs and embryonic stem cells. The combination of signals from these growth factors, molecules that guide the differentiation of stem cells into specific tissues, was sufficient to commit the cells toward progenitors that exhibit clear characteristics of renal cells in only four days.

The researchers then guided these cells to further differentiated into organ structures similar to those found in the ureteric bud by culturing them with kidney cells from mice. This demonstrated that the mouse cells were able to provide the appropriate developmental cues to allow human stem cells to form three-dimensional structures of the kidney.

In addition, Izpisua Belmonte’s team tested their protocol on iPSCs from a patient clinically diagnosed with polycystic kidney disease (PKD), a genetic disorder characterized by multiple, fluid-filled cysts that can lead to decreased kidney function and kidney failure. They found that their methodology could produce kidney structures from patient-derived iPSCs.

Because of the many clinical manifestations of the disease, neither gene- nor antibody-based therapies are realistic approaches for treating PKD. The Salk team’s technique might help circumvent this obstacle and provide a reliable platform for pharmaceutical companies and other investigators studying drug-based therapeutics for PKD and other kidney diseases.

“Our differentiation strategies represent the cornerstone of disease modeling and drug discovery studies,” says lead study author Ignacio Sancho-Martinez, a research associate in Izpisua Belmonte’s laboratory. “Our observations will help guide future studies on the precise cellular implications that PKD might play in the context of kidney development.”

Source: Science Daily

 

 


CPR for 38 Minutes or Longer Chance to Survive Cardiac Arrest

Performing CPR for 38 minutes or longer can improve a patient’s chance of surviving cardiac arrest, according to a study presented at the American Heart Association’s Scientific Sessions 2013.

Sustaining CPR that long also improves the chances that survivors will have normal brain function, researchers said.

Cardiac arrest occurs when electrical impulses in the heart become rapid or chaotic, causing it to suddenly stop beating.

About 80 percent of cardiac arrests — nearly 288,000 people — occur outside of a hospital each year, and fewer than 10 percent survive, according to the American Heart Association.

Research has found that early return of spontaneous circulation — the body pumping blood on its own — is important for people to survive cardiac arrest with normal brain function. But little research has focused on the period between cardiac arrest and any return of spontaneous circulation.

Using a massive registry tracking all out-of-hospital cardiac arrests in Japan in 2005-11, researchers studied how much time passed between survivors’ collapse and the return of spontaneous circulation, and how well brain function was preserved a month later.

Survivors were considered to have fared well neurologically if they were alert and able to return to normal activities or if they had moderate disability but were well enough to work part-time in a sheltered environment or take part in daily activities independently.

The time between collapse and return of spontaneous circulation for those who fared well was 13 minutes compared to about 21 minutes for those who suffered severe brain disability, said Ken Nagao, M.D., Ph.D., professor and director-in-chief of the Department of Cardiology, CPR and Emergency Cardiovascular Care at Surugadai Nihon University Hospital in Tokyo.

After adjusting for other factors that can affect neurological outcomes, researchers found that the odds of surviving an out-of-hospital cardiac arrest without severe brain damage dropped 5 percent for every 60 seconds that passed before spontaneous circulation was restored.

Based on the relationship between favorable brain outcomes and the time from collapse to a return of spontaneous circulation, the researchers calculated that CPR lasting 38 minutes or more was advisable.

“It may be appropriate to continue CPR if the return of spontaneous circulation occurs for any period of time,” said Nagao.

The 2010 AHA Guidelines for CPR and ECC advice bystanders to perform CPR until emergency crews arrive.

Source: Eureka Science News


3 healthy Thanksgiving swaps

Healthy, gluten-free living is an easy endeavor when you consider using “this” instead of “that”. By swapping out less health-conscious ingredients for more nutritious ones, you’re sure to be eating a balanced diet you can smile about.

Try these easy swaps and then check out my gluten-free, dairy-free and vegan Almond Cookies – they’re the perfect guilt-free Thanksgiving dessert!

Apple cobbler

Make your own homemade apple cobbler using almond flour, ground cinnamon and baked apples instead of white flour with refined sugar. It isn’t necessary to use a ton of butter or oil in your holiday baking; use nonstick baking spray to coat the baking dish and bake the apples until tender to ensure they release their natural, sweet juices.

Gravy

Pass on the salty canned gravy. Instead, make your own gravy by saving the drippings from your roasted turkey and adding a bit of fresh herbs, such as 

herbs de Provence, for an extra kick of flavor without the additives in processed gravy.

Potatoes

Swap your white mashed potatoes for sweet potatoes. You can serve mashed sweet potatoes or enjoy sweet potato casserole without the added butter and cream. Simply bake the 

potatoes then mash them together, along with olive oil, sea salt and freshly ground pepper for a flavorful side dish without the added saturated fat.

Source: Fox News

 


World Bank Urges Cleaner Stoves to Save Lives, Fight Global Warming

Simple measures to reduce pollution from cooking stoves in developing nations could save a million lives a year and help slow global warming, a World Bank study showed on Monday.

Tighter restrictions on diesel emissions, for instance from car exhausts, could also avert 340,000 premature deaths annually by reining in soot and other heat-trapping pollutants that are also stoking climate change, the report claimed.

The study called for tough limits on pollution from methane and soot, which can settle on snow and ice and hasten a thaw by darkening its surface, in everything from cooking and heating to mining and flaring by the oil and gas industry.

“The damage from indoor cooking smoke alone is horrendous – every year, four million people die from exposure to the smoke,” World Bank President Jim Yong Kim said in a statement of the study “On Thin Ice: How Cutting Pollution can Slow Warming and Save Lives”.

Many people in developing nations cook on open fires with wood or coal, exposing people – mainly women and children – to fumes that cause everything from respiratory problems to heart disease.

“If more clean cook-stoves – stoves that use less or cleaner fuel – would be used it could save one million lives,” the report said.

Permafrost

Mass produced, such stoves can cost a few dollars each.

Monday’s study was co-written by the International Cryosphere Climate Initiative – the cryosphere is the world’s ice, snow and permafrost, from Siberia to Antarctica.

New stoves use fans to improve combustion, or less-polluting fuels such as gas from crop waste or manure.

“If we act fast and cut common pollutants like soot and methane we can slow the rate of warming… and if we did so we can save millions of lives,” Rachel Kyte, World Bank vice president for sustainable development, told a telephone news conference.

Tighter controls on pollution could also boost crop growth, the report said. Plant growth can be hampered by a haze of pollution.

A 2011 U.N. study estimated that measures to limit air pollutants such as methane and soot could slow the pace of global warming by 0.5 degrees Celsius (0.9 Fahrenheit) by mid-century.

A study in August 2013, however, said the benefits would be far less. Temperatures have risen by about 0.8 C (1.4 F) compared to before the Industrial Revolution.

Almost 200 nations will meet in Warsaw from Nov. 11-22 to consider ways to combat global warming. They have agreed to work out by the end of 2015 a deal that will enter into force from 2020.

Source: Voice of America

 


4 minor measures that could save your life

Breathe easy: Simply switching inhalers could prevent more than half of the 2.1 million asthma-related ER trips per year, according to a recently released U.K. study.

What gives? The bulk of asthma-related ER visits result from people losing track of how much medication they have left—or taking breaths from inhalers that are actually empty, researchers say.

But a rescue inhaler—featuring a dose counter that shows how much medicine is left—can cut hospital admissions. The gadgets are widely available, but if you’re insurance doesn’t cover them, companies like Puff Minder offer an attachment that will help you keep track.

Give your airways a break by avoiding these 5 Health Threats to Your Lungs.

Here are three other simple tips or innovations that could save your life:

The right kind of smoke detector

Unlike ionization detectors—the most-common type in the U.S. and great at sensing flames—photoelectric detectors are quicker to recognize the smoldering, toxic smoke released by slow burns from frayed electrical cords or forgotten cigarettes. That’s according to experiments from Texas AM professor B. Don Russell, who recommends ponying up a few extra bucks to buy a dual detector equipped with both technologies. First Alert offers a popular option.

Can’t remember the last time you checked to see if your smoke alarm was working? Know these 4 Dangerous Home Mistakes You don’t know you’re Making.

Car technology

Like airbags and electronic stability control, forward collision assistance—auto-braking—is one of those innovations that works so well it’ll probably be in every car a decade from now. Your risk of ending up in an accident falls 20 percent if your ride has this technology, according to research from the Insurance Institute for Highway Safety. If you can afford it, most luxury car brands currently offer these systems.

We drove thousands of miles to find Our Favorite Road Trip Cars that are perfect for any vacation.

Coffee

Swallowing some Joe could counteract some of the airway-closing effects of a severe reaction to allergens like nuts, shows research from Korea. By blocking the release of throat-tightening histamine, coffee’s compounds cut the rate of death among allergy-ridden rodents by half, the research shows. It’s not yet proven to be effective in humans, so never count on it over emergency help—but if you ever find yourself waiting for paramedics or without an epinephrine shot, it’s worth a try.

Don’t fall into the medicine trap! Check out these 5 Allergy Medicines to Avoid.

Source: health Medicine Network

 


Non-surgical nose job offers patients results without commitment

We all have that one thing that we would like to change about ourselves – weight, height, hair color. For 35-year-old Olivia Kraus – it was her nose.

“When I see my nose I’m not satisfied because I see this dent and crack in it,” Kraus said. “I don’t like it.”

Kraus worried that it was a problem that would only worsen with age.

“My father has the crack in his nose and it has drooped as he’s gotten older,” Kraus said. “So I live in fear about how it’s going to progress.”

Kraus said she was always scared to get a nose job because it would be permanent. So when a friend told her about a non-surgical procedure to fix the crack in her nose, she decided to go see Dr. Eric Schweiger, a dermatologist in New York City.

“It’s a procedure that can be done in about 15 minutes,” Schweiger said. “The patient comes in and has an identifiable issue with their nose, like a bump or a downward turning of their nose, and we use filling material to correct that problem.”

After applying a topical anesthetic, Dr. Schweiger injected a filler, called Radiesse, into Kraus’ nose. The filler is made of a protein that commonly found in human bone.

“We can physically mold the filler when it’s under the skin into the place that we want it to be,” Schweiger said. “We also put a little bit of Botox in the muscle that kind of pulls down the nose – and that, in about five days can kind of help push up the nose.”

Not everyone is a candidate for the procedure and possible side effects, which typically go away within five to seven days after the procedure, include bruising and swelling.  The results are not permanent, Schweiger said, which means most patients will have to come back in for touch ups every nine months to a year.

Kraus, however, believed the results were worth it.

“The crack is gone and it looks really good,” Kraus said. “I can’t wait to see how it progresses over the next couple of days. But if it stayed the way it is right now I’d be really happy.”

Source: Airing News

 


Gestational diabetes on the rise: What every mom should know

The percentage of women diagnosed with gestational diabetes is increasing in the United States and the American Diabetes Association estimates that it will occur in up to 18 percent of all pregnancies.

Experts agree that it’s not just a problem during pregnancy; it can actually cause a lifetime of complications in both mothers and their children.

Learn what the latest research on gestational diabetes suggests and what you can do to prevent and manage it.

Are you at risk?

Gestational diabetes is a medical condition that causes blood sugar levels to rise during pregnancy. When you eat, the food is converted to glucose, which the body uses for energy. But the only way glucose gets into the cells is through insulin, and when the cells become resistant to insulin, diabetes occurs.

Gestational diabetes can be genetic and some ethnic groups – American Indian, African American, Asian, and Hispanic – are more prone. Women over the age of 25, and especially those over 35, have a higher risk.

If you had a baby who weighed more than 9 pounds, even if you were never diagnosed with gestational diabetes, chances are you could have it during your next pregnancy.

Some studies show that 50 percent of women who have gestational diabetes have no other risk factors. Yet experts agree that lifestyle is the most important predictor.

“More people are going into pregnancy overweight,” said Dr. Danine Fruge, director of women’s health and family medicine at the Pritikin Longevity Center and Spa in Miami, Fla.

If you’re overweight or obese, your chances of having gestational diabetes is two and four times higher, respectively, than a woman at a normal weight, according to a report in the journal Diabetes Care. If you smoke, your chances double.

Many women who aren’t diabetic going into pregnancy may still have metabolic syndrome and insulin resistance – risk factors they may not have had if they had a normal body mass index (BMI), Fruge said.

Health problems for moms and babies

During pregnancy, moms with gestational diabetes can also have high blood pressure, preeclampsia and eclampsia.

And because babies born to moms with the condition also have elevated blood sugar levels, they’re likely to be overweight, which can cause birth complications, interventions, and can up the chances of having a cesarean section.

After birth, when insulin starts to kick in and the baby’s blood sugar drops, the infant is at risk for seizures, jaundice, polycythemia vera, low calcium and low magnesium, according to Dr. Timothy Morley, medical director for Women’s Healthy Hormones and Founder of BodyLogicMD in New York City.  However, these conditions are very rare.

A lifelong condition

Gestational diabetes goes away after giving birth, but its effects on both mom and baby can last a lifetime.

Women with gestational diabetes are at risk for high blood pressure, type 2 diabetes and heart disease. By age 50, women who had gestational diabetes have a 26 percent higher 10 year-risk for heart disease, according to a recent study in the journal Circulation.

“You are not out of the woods just because you’re not pregnant anymore,” Fruge said.

Your baby may also face high blood pressure, heart problems, and diabetes, and he or she is more likely to be overweight or obese later on in life.

If you’re at risk for gestational diabetes, the good news is that there are things you can do to prevent and manage it now:

Lower your BMI

“Before you’re pregnant, lose weight.” Morley said. If you had a baby that was more than 9 pounds, ask your doctor about pre-family planning for your next pregnancy, which can help you get your weight under control.

Monitor your blood sugar

If you have gestational diabetes, daily blood sugar monitoring at home is what will determine how healthy your pregnancy will be, according to Fruge.

Clean up your diet

Before, during and after pregnancy, limit processed foods, salt and sugar – and focus on eating fresh fruits and vegetables, whole grains, lean protein and healthy fats. Your doctor can refer you to a medical nutrition therapist who can help you with a diet plan and set healthy pregnancy weight gain goals.

Exercise

Thirty minutes of exercise five to six days a week before pregnancy is important, but if you have gestational diabetes, you should exercise up it to seven days a week. “Your body is having tremendous difficulty doing its daily work, and exercise is such an incredible helper to using the blood sugar for energy,” Fruge said.  Be sure to talk to your doctor about the type of exercise and intensity that’s right for you

Source: Heal  con


Simple Health Tips That Could Save 200,000 Lives a Year

With heart disease still America’s No. 1 killer, the CDC emphasizes simple health tips to save the lives of people under 65.

Simple changes to Americans’ routines could help prevent 200,000 deaths a year, according to the U.S. Centers for Disease Control (CDC).

Specifically, better attention to heart and cardiovascular health could drastically improve the health of the nation.

“Nothing is more important than lowering the rate of heart disease and stroke,” Tom Frieden, CDC director, told reporters Tuesday morning. “They are the No. 1 killer in the U.S.”

Heart disease and stroke accounted for an estimated 200,000 preventable deaths—one out of every three—in the U.S. in 2010, according to the CDC’s monthly report on preventable diseases.

As a doctor, Frieden said he finds these statistics heartbreaking.

“One preventable death is one too many,” he said. “These findings are really striking because we’re talking about hundreds of thousands of deaths that don’t have to happen.”

More than half of those deaths occurred in people under the age of 65 and could have been prevented with lifestyle changes, better medical care, or stronger public health policies.

While progress has been made in lowering the rates of death from preventable heart disease in the 64 to 75 age range, the population in that group is increasing, so the numbers have remained unchanged over the last decade. African-Americans and men remain the highest at-risk groups.

Zip Code vs. Genetic Code

For many people, the risk of early death from heart disease and stroke may be “more influenced by your zip code than your genetic code,” Frieden said.

While many people have a genetic disposition for heart disease, many states carry a three- to ten-fold higher risk compared to states and counties with the lowest rates. For instance, Minnesotans average 36.3 deaths per 100,000 people, while Washington D.C. has 99.6 deaths per 100,00 people.

The areas with the highest risk of heart-related premature death are concentrated primarily in southern Appalachia and much of Tennessee, Arkansas, Mississippi, Louisiana, and Oklahoma. States in the West, Midwest, and Northeast regions had much lower rates.

“That difference reflects the improvements we can make overall,” Frieden said.

How to Prevent Death from Heart Disease

The U.S. Department of Health and Human Services has launched its “Million Hearts Campaign” to try to prevent 1 million heart disease deaths by 2017 by increasing public knowledge about heart attacks, strokes, and other serious health problems.

Frieden says smoking cessation and better management of blood pressure and cholesterol are the easiest and most effective ways to lower your heart disease risk. Increased exercise and a better diet are a great way to start.

While access to quality preventative healthcare, including access to cholesterol-lowering drugs, has been an issue in the past, Frieden says the new Marketplace under the Affordable Care Act, which opens Oct. 1, will hopefully close that coverage gap and offer people the care they need.

To improve the health of its residents, Frieden said local communities should focus on more open spaces for exercise, including places to walk, and fewer places that allow smoking.

“Despite progress against heart disease and stroke, hundreds of thousands of Americans die each year from these preventable causes of death,” Frieden said. “Many of the heart attacks and strokes that will kill people in the coming year could be prevented by reducing blood pressure and cholesterol and stopping smoking.”

Source: health Line