FDA Orders More Stringent Labeling For Opioid Drugs

The US Food and Drug Administration has announced safety labeling changes and post-market study requirements for extended-release and long-acting opioid analgesics

The US Food and Drug Administration has recently announced safety labeling changes and post-market study requirements for extended-release and long-acting opioid analgesics.

Earlier this year the Center for Disease Control’s Vital Signs report showed that prescription painkiller overdoses killed nearly 48,000 women between 1999 and 2010. The new regulations aim to cut the number of deaths per year from opioid dependence.

“The FDA is invoking its authority to require safety labeling changes and post-market studies to combat the crisis of misuse, abuse, addiction, overdose and death from these potent drugs that have harmed too many patients and devastated too many families and communities. Today’s action demonstrates the FDA’s resolve to reduce the serious risks of long-acting and extended release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain,”FDA Commissioner Margaret Hamburg said.

Oxycontin, Opana ER, Embeda, Palladone and MS Contin fall into this class of drugs. The medications contain narcotics such as oxycodone or morphine.

One warning restricts the use of these painkillers to those who need it on daily basis, long-term pain management and for whom non-narcotic drugs haven’t worked.

A second warning targets pregnant women to the danger of narcotic withdrawal syndrome in their newborns.

The FDA is requiring the drug companies that make these product to conduct further studies and clinical trials as more information’s is needed to assess the serious risks associated with long term use of ER/LA opioids.

“The FDA remains committed to improving the safety of opioids and to continuing to engage in efforts to evaluate and mitigate the risks associated with opioid use,” said Dr Douglas Throckmorton, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.

Source: http://www.counselheal.com/articles


NSW offers $7.5m incentive to add fluoride to water

Health minister hopes to persuade 15 local authorities to change their minds on fluoridation, but won’t force them

The New South Wales government is offering a $7.5m incentive that it hopes will persuade recalcitrant councils to fluoridate their drinking water.

But the state health minister, Jillian Skinner, said the government would not support a Labor bill that would give state authorities power to force local councils to put the tooth-strengthening chemical in their drinking water.

The government wanted to support councils in making their own decisions, rather than take a “big stick” approach.

“It is for this reason we are boosting our infrastructure support for councils who have avoided fluoridation to encourage them to deliver this vital service to the community,” Skinner said.

The minister says the funds are aimed at encouraging those councils to reverse their decisions.

Last week, Lismore council overturned a ban on fluoride after seven years of lobbying by local health professionals. However, there are still 15 council areas across the state that don’t fluoridate their water, the government says.

Councils can currently choose not to add the dental health booster to their water supplies, with several recent attempts by councils to block fluoridation.

A bill introduced into NSW parliament this month by opposition health spokesman Andrew McDonald would give the government power to mandate fluoridation in council public water supplies.

Skinner on Wednesday said the government wouldn’t support the proposed legislation.

“Recent outcomes have shown that with education and information, local councils are able to make informed decisions about fluoridation,” she said in a statement.

Source: The guardian.com


Love hormone play role in social interaction

A special type of social behavior tied to the presence of oxytocin receptors in the nucleus accumbens

Researchers at the Stanford University School of Medicine have shown that oxytocin – often referred to as “the love hormone” because of its importance in the formation and maintenance of strong mother-child and sexual attachments – is involved in a broader range of social interactions than previously understood.

The discovery may have implications for neurological disorders such as autism, as well as for scientific conceptions of our evolutionary heritage.

Scientists estimate that the advent of social living preceded the emergence of pair living by 35 million years. The new study suggests that oxytocin’s role in one-on-one bonding probably evolved from an existing, broader affinity for group living.

Oxytocin is the focus of intense scrutiny for its apparent roles in establishing trust between people, and has been administered to children with autism spectrum disorders in clinical trials. The new study, to be published Sept. 12 in Nature, pinpoints a unique way in which oxytocin alters activity in a part of the brain that is crucial to experiencing the pleasant sensation neuroscientists call “reward.” The findings not only provide validity for ongoing trials of oxytocin in autistic patients, but also suggest possible new treatments for neuropsychiatric conditions in which social activity is impaired.

“People with autism-spectrum disorders may not experience the normal reward the rest of us all get from being with our friends,” said Robert Malenka, MD, PhD, the study’s senior author. “For them, social interactions can be downright painful. So we asked, what in the brain makes you enjoy hanging out with your buddies?”

Some genetic evidence suggests the awkward social interaction that is a hallmark of autism-spectrum disorders may be at least in part oxytocin-related. Certain variations in the gene that encodes the oxytocin receptor – a cell-surface protein that senses the substance’s presence – are associated with increased autism risk.

Malenka, the Nancy Friend Pritzker Professor in Psychiatry and Behavioral Sciences, has spent the better part of two decades studying the reward system – a network of interconnected brain regions responsible for our sensation of pleasure in response to a variety of activities such as finding or eating food when we’re hungry, sleeping when we’re tired, having sex or acquiring a mate, or, in a pathological twist, taking addictive drugs. The reward system has evolved to reinforce behaviors that promote our survival, he said.

For this study, Malenka and lead author Gül Dölen, MD, PhD, a postdoctoral scholar in his group with over 10 years of autism-research expertise, teamed up to untangle the complicated neurophysiological underpinnings of oxytocin’s role in social interactions. They focused on biochemical events taking place in a brain region called the nucleus accumbens, known for its centrality to the reward system.

In the 1970s, biologists learned that in prairie voles, which mate for life, the nucleus accumbens is replete with oxytocin receptors. Disrupting the binding of oxytocin to these receptors impaired prairie voles’ monogamous behavior. In many other species that are not monogamous by nature, such as mountain voles and common mice, the nucleus accumbens appeared to lack those receptors.

“From this observation sprang a dogma that pair bonding is a special type of social behavior tied to the presence of oxytocin receptors in the nucleus accumbens. But what’s driving the more common group behaviors that all mammals engage in – cooperation, altruism or just playing around – remained mysterious, since these oxytocin receptors were supposedly absent in the nucleus accumbens of most social animals,” said Dölen.

For more : medical news today


Is your doctor prescription-happy?

25 percent of those cases, the drugs were prescribed for viruses, which can’t be treated with antibiotics

When you’re sick, you’ll generally take whatever prescription your doctor writes up. After all, he’s the one who went to med school. But failing to ask him a few questions could result in a serious dose of unnecessary antibiotics, according to a new study in the Journal of Antimicrobial Chemotherapy.

Researchers examined two major medical surveys over 2 years and found that 60 percent of the time, doctors chose the strongest types of antibiotics when doling out prescriptions. In 25 percent of those cases, the drugs were prescribed for viruses, which can’t be treated with antibiotics.

That’s a problem because strong antibiotics—often referred to as broad spectrum—can kill “good” bacteria, which could trigger future problems like eczema, asthma, inflammatory bowel disease, and obesity, says study coauthor Adam L. Hersh, M.D., Ph.D., of the University of Utah. “When these antibiotics are overused, they’re less likely to work in the future when they’re needed,” Hersh says. (And while you’re at it, make sure you know the

So how can you know if you really need that one-a-day knockout pill?

1. You don’t always need a doctor.

Viruses don’t respond to antibiotics, and most of the time infections go away on their own, says Men’s Health family medicine advisor Ted Epperly, M.D. If your fever is less than 102 degrees and you can function pretty well, wait and see if the usual symptoms—fatigue, headache, sore throat, diarrhea—get worse before scheduling an appointment.

2. Ask for a narrow spectrum antibiotic—if your condition calls for it.

Docs most commonly over-prescribe antibiotics for upper respiratory conditions like coughs, colds, and bronchitis. If you’ve got something less common, like a skin infection, ask your M.D. for a narrow spectrum antibiotic. (Standard options include penicillin and cephalosporin, or Keflex.) In fact, request the narrowest spectrum possible for the shortest period of time, advises Dr. Epperly. Doctors will prescribe for 10- to 14-day cycles, when in reality you might only need 3 to 5 days, he says.(Give your airways a break by avoiding these

3. Be upfront with your doc.

Most physicians feel like they have to do something for you or you won’t be happy, which can lead to an unnecessary antibiotic, says Dr. Epperly. Say, “If you think this might be a virus, its okay with me if I don’t get an antibiotic.” That will open up the door for your doc to say, “No, I don’t think you really need one” or “Let’s give it a few days.”

4. But don’t be pushy.

You might think antibiotics have magical properties, but don’t nudge your doctor into giving you a pill if he doesn’t think it’s necessary. Doctors often cite patient pressure as the reason for prescribing inappropriately, Hersh says. Don’t be the guy saying, “Can I get a Z-Pak today?” if your doesn’t doc think it’s a good idea. (Do the research and get the truth about your doctor’s next prognosis

Source: Fox news


Girl with fatal brain infection is now discharged from hospital

A 12-year-old Arkansas girl who survived a rare and often fatal infection caused by a brain-eating amoeba says she is lucky to be alive.

 

A 12-year-old Arkansas girl who survived a rare and often fatal infection caused by a brain-eating amoeba says she is lucky to be alive.

Kali (KAY’-lee) Hardig, her parents and doctors spoke to reporters Wednesday before she was to be released from Arkansas Children’s Hospital.

Kali says she has missed playing with her dog and seeing friends after being hospitalized in July.

The girl was diagnosed with an infection caused by a brain-eating amoeba. Health officials say there were 128 reported infections in the United States between 1962 and 2012. Before Kali, doctors could only point to one known survivor in the U.S. and another in Mexico.

Health officials believe Kali became sick after a trip to an Arkansas lake. The amoeba is often found in warm, fresh water.

This article is appeared in fox news

 


Chobani recalls moldy yogurt after complaints, FDA probe

Chobani_AP2.jpgU.S. yogurt-maker Chobani is officially recalling moldy cups of Greek yogurt after customers complained that the product tasted runny and fizzy and some reported illnesses.

The recall, announced on Thursday, follows nearly a week after Chobani sought to quietly remove the yogurt from store shelves without alerting the public, a strategy the U.S. Food and Drug Administration called “unusual.”

Privately-held Chobani said it is removing the product “due to some claims of illness,” though a spokeswoman, Amy Juaristi, downplayed the claims, saying the mold, which can occur in dairy, “is unlikely to have ill health effects.” Juaristi said tainted cups would be replaced.

FDA spokeswoman Tamara Ward said the agency is continuing its discussions with Chobani. She declined to give further details. On Wednesday Ward said the FDA was looking into the situation to assess the level of risk to the public and to determine whether the company was communicating appropriately with the public.

Chobani’s problems began last Friday, when unhappy yogurt-eaters began to complain, flooding the company’s Facebook and Twitter pages reporting foul smells, bloated containers, and gastrointestinal distress.

Some commented on the characteristically thick Greek yogurt’s “runny” consistency and said they would not buy Chobani again.

The company had asked some retailers last week to remove certain yogurt cups from store shelves but did not issue a formal recall.

Thursday’s recall was “a voluntary decision to remove any final products that might have been out there,” Juaristi said.

The private company said the problem had affected less than 5 percent of its production and that 95 percent of the tainted cups had been identified by Thursday morning. The mold was limited to yogurt cups produced at Chobani’s Idaho plant. The company also has a plant in New York and one in Australia.

Chobani said cups with the code 16-012 and expiration dates between 9/11/2013 and 10/7/2013 would be replaced.

Euromonitor, a sales tracking firm, ranks Chobani the second-best selling brand in the U.S. Greek-style yogurt market, after Yoplait. Chobani’s chief executive and founder is Hamdi Ulukaya.

Greek-style yogurt, which is thicker, creamier and often higher in protein than other types of yogurt, now makes up more than 40 percent of the U.S. yogurt market, Reuters has reported.
Read more: http://www.foxnews.com/health/2013/09/06/chobani-recalls-moldy-yogurt-after-complaints-fda-probe/#ixzz2eC1qecVf

 


Health officials caution against drug ‘Molly’ festival deaths

Carl Hart many people continue to use Molly is because of ineffective scare tactics

The popular New York City music festival Electric Zoo was cancelled on Sunday after two concert-goers overdosed and died while using the drug Molly. The deaths have prompted the Drug Enforcement Agency (DEA) and other health officials to better educate the public about the dangers of the drug, Medical Daily reported.

Molly is considered to be a “pure” form of the methamphetamine derivative MDMA, which is often mixed with other substances to create ecstasy. The drug has been linked to a growing number of casualties throughout the United States, as many users tend to disassociate it from other street drugs.

However, representatives for the DEA warn that Molly isn’t as “innocent” as most people believe it to be.

“There’s no ‘good batch’ of molly, MDMA, Ecstasy,” Anthony Pettigrew, a spokesman for the DEA New England division, told the Boston Herald. “This is stuff that’s made in somebody’s bathtub in Asia, the Netherlands, Canada; you have no idea what is in this stuff. Dealers want to make more money, so they’ll mix and adulterate the stuff with meth and any number of other drugs to addict people to it.”

Molly lacks many of the adverse side effects associated with other illegal substances, possessing low addiction rates and few apparent withdrawal symptoms.  However, users can experience devastating health effects if they continue to take the drug in higher and higher doses.  Large amounts of Molly can lead to sharp increases in body temperature, resulting in rare instances of hyperthermia or liver, kidney or cardiovascular system failure.

Carl Hart, an associate professor of psychology at Columbia University in New York City, told Medical Daily that the reason so many people continue to use Molly is because of ineffective scare tactics.  Since many young individuals have already tried the drug without experiencing adverse complications, health officials need to focus on the rare events that can occur from taking the drug.

“What we’ve done and what we consistently do is we include people that exaggerate the harms,” Hart told reporters. “Kids are not listening because they’ve already had the experience. … They (think they) should reject everything we’re saying because we’re not being accurate, and they know it.”
Read more: Fox news


European men grow 11cm in a century

The average height of European men grew by a surprising 11 centimeters from the early 1870s to 1980, reflecting significant improvements in health across the region, according to new research published on Monday.

Contrary to expectations, the study also found that average height accelerated in the period spanning the two World Wars and the Great Depression, when poverty, food rationing and hardship of war might have been expected to limit people’s growth.

The swift advance may have been due to people deciding to have fewer children in this period, the researchers said, and smaller family size has previously been found to be linked to increasing average height.

“Increases in human stature are a key indicator of improvements in the average health of populations,” said Timothy Hatton, a professor economics at Britain’s University of Essex who led the study.

He said the evidence – which shows the average height of a European male growing from 167 cm to 178 cm in a little over a 100 years – suggests an environment of improving health and decreasing disease “is the single most important factor driving the increase in height”.

The study, published online in the journal Oxford Economic Papers, analyzed data on average men’s height at around the age of 21 from the 1870s up to around 1980 in 15 European countries.

The study only looked at men, the researchers said, because extensive historical data on women’s heights is hard to come by.

For the most recent decades, the data on men were mainly taken from height-by-age surveys, while for the earlier years the analysis used data for the heights of military conscripts and recruits.

On average, men’s height had grown by 11 centimeters (cm) in just over a century, the researchers found, but there were differences from country to country.

In Spain, for example, average male height rose by around 12 cm from just under 163 cm in 1871-1875 to just under 175 cm in 1971-5, while in Sweden, men’s average height increased by 10 cm from just over 170 cm to almost 180 cm in the same period.

The researchers found that in many European countries – including Britain and Ireland, the Scandinavian countries, Netherlands, Austria, Belgium and Germany – there was a “distinct quickening” in the pace of advance in the period spanning the two World Wars and the Great Depression.

“This is striking because the period largely predates the wide implementation of major breakthroughs in modern medicine and national health services,” they wrote.

Hatton said one possible reason, alongside the decline in infant mortality, for the rapid growth of average male height in this period was that there was a strong downward trend in fertility at the time – and smaller family sizes have previously been found to be linked to increasing height.

Other height-boosting factors included higher per capita incomes, more sanitary housing and living conditions, better education about health and nutrition and better social services and health systems
Source: http://www.foxnews.com/health/2013/09/03/bigger-and-healthier-european-men-grow-11cm-in-century/#ixzz2dtumDGot

 


Ali Hussain – a 14 year old with 110 year old body

The fourteen year old boy from Bihar suffers from the rare disorder which causes rapid ageing

A boy born with the appearance and physical maladies of an old man – the story sounds familiar. After all most of us have seen `The curious case of Benjamin Button`, a film in 2008 which is loosely based on F Scott Fitzgerald`s 1922 short story of the same name, said to be one of the earliest literary pieces to have highlighted progeria, an extremely rare genetic disease characterized by rapid ageing.
The condition was highlighted by R Balakrishnan in the 2009 Bollywood film `Paa` with Amitabh Bachchan as the lead protagonist diagnosed with the disorder.

Kids born with this rare genetic disorder have dramatically tougher lives.

Ali Hussain Khan`s story is no different. The fourteen year old teenager from Bihar suffers from the rare disorder which causes rapid ageing and is known to affect just 80 people worldwide.

Ali, whose body ages eight times faster than normal, has seen five of his siblings die from the same genetic condition.

Ali’s parents Nabi Hussain Khan, 50, and Razia, 46, are first cousins and have had eight children in total. Only two of the girls out of eight were born healthy.

Progeria or Hutchinson-Gilford Progeria Syndrome is an extremely rare genetic disease wherein symptoms resembling aspects of ageing are manifested at a very early age. The disorder has a very low incident rate, occurring in an estimated 1 per 8 million live births. Children born with the rare disorder live only till their mid teens and early twenties.

Children with progeria usually develop the first symptoms during their first few months, characterized by changes in skin, abnormal growth and loss of hair. There has been no significant breakthrough in the treatment of this disease or reversing the symptoms of aging.

Source: http://zeenews.india.com/news/health/diseases/the-curious-case-of-ali-hussain-a-14-year-old-with-110-year-old-body_23587.html

 


Dancing is good for health of Scots:

http://i1.dailyrecord.co.uk/incoming/article1254099.ece/ALTERNATES/s615/4145153-1254099.jpg

Activities such as dancing, reading and going to the theatre have a “positive impact” on the health of Scots, new research has suggested.

The Scottish government-commissioned study was based on data from the Scottish Household Survey 2011.  It found that people who take part in or attend culture events are more likely to report “good health and life satisfaction” than those who do not.

The report comes on the day Commonwealth Games tickets go on sale.

Glasgow will host the event in the summer next year.

The research found that regardless of factors such as age, economic status, income, education and disability, cultural participation was positive for health and wellbeing.

Its key findings included:

  • Those who attended a cultural place or event in the previous 12 months were almost 60% more likely to report good health than those who did not
  • Those who visited a library or a museum were almost 20% more likely to report good health than those who had not
  • Those who visited a theatre were almost 25% more likely to report good health than
  • Those who participated in dance were 62% more likely to report good health than those who did not
  • And those who read for pleasure were 33% more likely to report good health than those who did not

Culture Secretary Fiona Hyslop said in response to the report, The Impact of Cultural Engagement and Sports Participation on Health and Satisfaction with Life in Scotland 2013, said: “Starting young, and being encouraged to take part in culture as a child, makes it more likely that the benefits of taking part will be experienced as an adult.

“That’s why this government has funded activities like Bookbug, Scottish Book Trust’s Early Years program, which encourages parents and children to read together from birth, and the Royal Scottish National Orchestra’s Astar CD, which is helping parents in Scotland to introduce their babies to the joy of music.”

A total of 14,358 households were interviewed in the 2010/11 survey with the questions on culture being put to about 75% of the total sample, giving a sample size of 9,683 adults.