Thursday, September 19, 2013

Angelina Jolie's Double Mastectomy: Q&A

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U.S. Women Delay Motherhood, Teen Births Historically Low: CDC

Preterm births, low birth weight babies declined in 2011, report says

By Steven Reinberg

HealthDay Reporter

FRIDAY, June 28 (HealthDay News) -- As American women continue to delay parenthood, rates of teenage births and births for women in their early 20s are at all-time lows, federal health officials reported Friday.

U.S. women have their first baby at age 25.6 on average, according to 2011 figures released by the U.S. Centers for Disease Control and Prevention (CDC). This is up slightly from 2010 and significantly older than the 1970 average of 21.4 years.

Births to girls 15 to 19 declined 8 percent between 2010 and 2011, and births to women 20 to 24 years old dropped 3 percent to a record low, the CDC report stated.

"If this [trend] results in more births being planned and intended it is difficult to object to it," said Dr. Jeffrey Ecker, director of Obstetrical Clinical Research and Quality Assurance at Massachusetts General Hospital in Boston.

"If we are talking about a shift from early 20s to late 20s or early 30s, the expectation is that outcomes would be safe and healthy. The message isn't that it's fine to wait until a woman is in her late 30s or 40s to think about becoming pregnant," added Ecker, who is also chair of the American College of Obstetricians and Gynecologists' Committee on Obstetric Practice.

As women get older it is more difficult to become pregnant, Ecker said, adding that the likelihood of miscarriage and other complications also increases.

Overall, 3.9 million U.S. births were reported in 2011, representing the lowest general birth rate since 1998 -- 63.2 births per 1,000 women aged 15 to 44 -- and 1 percent less than in 2010, the CDC reported.

Birth rates were unchanged for women aged 30 to 34 but rose for women 35 to 44.

Births to unmarried women declined in 2011 for the third year in a row -- down another 2 percent from 2010.

Experts found good news in the report.

In terms of health, highlights are a leveling off of cesarean births and the continued decline in the preterm birth rate, said lead author Joyce Martin, an epidemiologist at CDC's National Center for Health Statistics, Division of Vital Statistics, Reproductive Statistics.

In 2011 the rate of cesarean delivery remained about the same as the year before -- nearly 33 percent of all births. Previously, the number of women undergoing C-sections had increased steadily, jumping 60 percent from 1996 to 2009.

Meanwhile, the rate of preterm deliveries (before 37 weeks) dropped in 2011 for the fifth straight year to 11.7 percent of all births, down 2 percent from 2010 and 8 percent from its high in 2006.

The rate of babies born at a low birth weight in 2011 was 8.10 percent -- down somewhat from 8.15 percent in 2010 and 2 percent lower than the 2006 peak of 8.26 percent.


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Superga Create World's Largest Shoe

Well that's one way to make an entrance. To announce their arrival in Hong Kong and China, Italian trainer brand Superga went big - creating a giant replica of the 2750 Classic Superga® featuring exclusive artwork designed by the students of SCAD Hong Kong, and installing it at the Marine Deck, a loading area for Cruise Ships in Hong Kong's Harbour City.

So mammoth was the shoe that the Guinness Book Of World Records have confirmed that it's the biggest in the world - measuring in at a whopping six metres high, two metres wide and three metres long.

Constructed by 18 design students from the city, the whopper of a trainer took 43 days to create , and uses 23 metres of shoelaces - and 42 buckets of paint were used to create the deisgn - a mash up of an Italian and Hong Kong landscape.  But our favourite fact of all from the team that created this masterpiece? 965 slices of pizza were munched during construction. 

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Cheap Protein

I bought some pork shoulder "Boston Butt" for $1.29/lb. I decided to try something new and make Char Siu. 

I had to trim the meat and there's a bone in it, so my yield is more like $1.6-1.7/lb, but that's still pretty cheap.


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FDA Approves New Drug to Fight Advanced Prostate Cancer

Xofigo was fast-tracked for approval and is meant for tumors that have spread to the bonesXofigo was fast-tracked for approval and is meant

By EJ Mundell

HealthDay Reporter

WEDNESDAY, May 15 (HealthDay News) -- The U.S. Food and Drug Administration announced Wednesday that it has approved a drug to help men with advanced prostate cancer whose disease has spread to the bones.

The drug, Xofigo, is targeted to patients with late-stage, metastatic disease that has spread to the bones but not to other organs, the FDA said in a news release. It is meant for patients who have already undergone surgery and/or drug therapies such as hormone-based treatments.

The FDA said Xofigo was approved more than three months ahead of the original August 2013 deadline the agency had set for a complete review. Instead, the drug was reviewed under the agency's "priority" review program, designated for medicines that appear safe and effective in a context where no good alternative therapy exists.

"Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, explained in the news release.

In a clinical trial involving more than 800 men with symptomatic prostate cancer that was resistant to hormonal therapy and had spread to the bones, men on Xofigo survived a median of 14 months compared to a little over 11 months for men taking a placebo. Side effects from Xofigo included nausea, diarrhea, vomiting and swelling of the legs and feet. Low levels of red and white blood cells, as well as platelets, were also reported among some patients taking Xofigo, the FDA said.

Pazdur noted that "Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer." The other drug, Xtandi, was approved by the FDA last August for men with hormone treatment-resistant prostate cancers that have spread or recurred, and who had previously been treated with the drug docetaxel.

According to the American Cancer Society, prostate cancer remains the leading cancer type among men outside of skin cancer, and about one man in every six will develop the illness during his lifetime. Caught early, it is often curable. About 239,000 new cases of prostate cancer are diagnosed among American men each year, and nearly 30,000 men die from the disease annually.

Xofigo is co-marketed in the US by Wayne, N.J.-based Bayer Pharmaceuticals and Algeta US of Cambridge, Mass.


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Looking for my twin on CC! 218,5'3",F,53. Westies218dVaugha

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The Best Road Races for Beginners

Newbie runners, we love you: We love your #UpnOut style, your workout mantras your willingness to try new things. Seriously -- we have our very own Running Virgin on staff!

So when you're confident enough to try your first race, we've got just one thing to say: You will rock it.

To help you pop your race-day cherry (sorry, we couldn't help ourselves), we've got the top 10 best races around the country for beginner runners. What makes 'em newbie-friendly? Great courses matched with a non-competitive atmosphere. So if you're into great views, bright colors,  supportive crowds or sweet swag there's a race here for you.

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Image Credit: Courtesy of Runner's World


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Yoga May Help Ease High Blood Pressure, Study Finds

Numbers were lowered when people engaged in a few sessions per weekNumbers were lowered when people engaged in a few

By Robert Preidt

HealthDay Reporter

WEDNESDAY, May 15 (HealthDay News) -- People who follow the ancient practice of yoga may be getting an added health boost, with a new study suggesting it can fight high blood pressure -- also known as hypertension.

"This study confirms many people's feelings that exercise may be useful in the control of hypertension," said Dr. Howard Weintraub, a cardiologist and associate professor of medicine at NYU Langone Medical Center in New York City. Weintraub was not connected to the new study.

Based on the new findings, "yoga would be a useful adjunct in the lowering of blood pressure in certain populations," he said.

In the study, researchers led by Dr. Debbie Cohen of the University of Pennsylvania tracked 58 women and men, aged 38 to 62, for six months.

Although the study couldn't prove a cause-and-effect relationship, doing yoga two to three times a week was associated with an average drop in blood pressure readings from 133/80 to 130/77, the researchers said.

In comparison, the average decrease in blood pressure was smaller (134/83 to 132/82) among people who ate a special diet but did not do yoga.

In a bit of a surprise, doing yoga in tandem with a special diet did not outperform doing yoga alone -- blood pressure numbers fell only slightly (135/83 to 134/81) among people who ate a special diet and also did yoga, the researchers said.

The small decline in blood pressure among people who ate a special diet and did yoga may be because doing both required a greater amount of time, making it more difficult for participants to stick with their regimens, the authors said.

Weintraub said the study shows that "yoga can have a favorable effect" on hypertension. Although the amount of change was small, he said, "some large population studies have suggested that changes of this magnitude could have very significant long-term benefits."

The study did have some limitations, including its relatively short length and the fact that most participants were young and had milder forms of high blood pressure, Weintraub said.

Another expert agreed that the ancient Indian practice of yoga might ease hypertension.

"Yoga, along with deep breathing exercises, meditation and inner reflection, is a good adjunctive and integrative cardiovascular approach to better health, including lowering blood pressure, as this data suggests," said Dr. David Friedman, chief of Heart Failure Services at the North Shore-LIJ Plainview Hospital, in Plainview, N.Y.

"In addition to proper diet and aerobic physical fitness most days of the week, I recommend that my patients take time each day for the above measures of finding disciplined inner peace, for improved health and well-being," he said.

The findings were presented Wednesday at the annual scientific meeting of the American Society of Hypertension, in San Francisco. Findings presented at medical meetings typically are considered preliminary until published in a peer-reviewed journal.


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Why are berries considered to be so healthy?

Posted June 29, 2013, 2:00 am Berries on Wooden Background

Berry season is here again, and I keep hearing that berries are healthy. What’s in them that makes them so good for you?

Here in the Northeast, we’re enjoying strawberries and looking forward to raspberries, blueberries and even blackberries further down the road.

Berries are perhaps the easiest way to follow the fruit part of the “eat more fruit and vegetables” advice you hear all the time, including from me. Berries naturally come in bite-sized portions. They’re sweet but have a nice low calorie count, partly because they contain a lot of water. If you don’t need to watch your calories — yes, there are people who are born thin — you can “pig out” on them. (Just don’t sprinkle much sugar on them.)

Berries contain vitamins (C and a little bit of E, because of the seeds) and some lesser-known nutrients. But they also, somewhat surprisingly, contain a fair amount of fiber. A cup of raspberries contains 8 grams of fiber, which is more fiber than you’ll find in a serving of oatmeal.

But what makes berries stand out nutritionally (and visually) are substances called anthocyanins. These substances give berries their vivid red, blue and purplish colors. Anthocyanins are antioxidants, which keep oxygen ions and other unstable molecules from damaging DNA, messing with cells’ energy-making machinery, stirring up inflammation in the body and having a variety of other harmful effects.

Vitamin supplements with antioxidants in them have generally not been proven to benefit your health as many had hoped. However, there’s still a lot of evidence that antioxidants are good for you, and foods that naturally contain antioxidants are thought to promote better health.

Anthocyanins are concentrated in the skin of berries (as well as other fruits). In general, the more intense the color, the higher the anthocyanin content. So blueberries and blackberries usually contain more anthocyanins than strawberries or raspberries. And wild berries have more antioxidants than their larger, paler, domesticated relations. Raspberries also contain a substance called ellagitannin, which imparts flavor and has antioxidant properties that add to the effects of anthocyanins.

Be sure to wash your berries right before eating them. Berries can harbor viruses, bacteria and other pathogens that cause foodborne illnesses.

For me, the best way to start a day is with a bowl of fresh, delicious berries. In fact, that’s what I had for breakfast today — with toast and coffee.

I have a patient who is very knowledgeable about food and reportedly a good cook. She once chastised me for writing about how healthy certain foods were. “The point you should be emphasizing is that they are delicious, because they are. The fact that they’re also healthy is the icing on the cake.” She’s right. And berries are healthier than the icing on the cake.

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Latest Edition of Psychiatry's 'Bible' Launched Amid Controversy

Authors say it defines disorders more concisely; critics say it will lead to over-diagnosis and unnecessary treatmentsAuthors say it defines disorders more concisely;

By Dennis Thompson

HealthDay Reporter

FRIDAY, May 17 (HealthDay News) -- As the American Psychiatric Association unveils the latest edition of what is considered the "bible" of modern psychiatry this weekend, the uproar over its many changes continues.

"This is unprecedented, the amount of commentary and debate and criticism," said Dr. Jeffrey Lieberman, president-elect of the American Psychiatric Association (APA). "It's been an interesting phenomenon, but the evidence is what it is. You have to evaluate it and then make your own determination of how compelling it is, and what would be best clinical practice."

The APA believes that changes made in this fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) will allow for more precise diagnoses of mental illnesses in patients, because this edition better characterizes and categorizes disorders.

But it has drawn fire from critics who are concerned that the revised version will lead to the diagnosis of mental illness in people who are simply being challenged by life.

More than 1,500 experts from 39 countries representing a wide variety of medical fields contributed to the new DSM-5, which was more than a decade in the making. Drafts of the manual were made available online as part of three open-comment periods that drew more than 13,000 responses.

One of the most notable naysayers has been Dr. Allen Frances, chairman of the task force that created the DSM-4, the previous version of the guide that has been in use since 1994.

In a commentary released the day of the DSM-5's release, Frances wrote that this latest revision introduces "several high-prevalence diagnoses at the fuzzy boundary with normality," and predicted that the changes "will probably lead to substantial false-positive rates and unnecessary treatment."

"In DSM-5, normal grief becomes a major depressive disorder, temper tantrums become disruptive mood dysregulation disorder, worrying about medical illness becomes somatic symptom disorder, gluttony becomes binge eating disorder and almost everyone will soon qualify for attention-deficit disorder," Frances said in an interview.

The main points of contention regarding the DSM-5 include:

The combination of a number of autism-related disorders into a single category called autism spectrum disorder. Although some clinicians believe that placing autism on a continuum from mild to severe will allow for more accurate diagnoses, others are concerned that high-functioning people with autism will find themselves unable to receive services or treatment. This is particularly true of people with Asperger's Syndrome, a diagnosis that has been eliminated from the DSM-5, critics of the new version contend.

"We're concerned that people who have Asperger's -- who have high-functioning autism -- are going to be dismissed as just being different when the majority of adults with Asperger's will need people to assist them in parts of their lives," said Karen Rodman, president and founder of Families of Adults Affected With Asperger's Syndrome.

"We are very concerned that medicine is going to drop the ball again, and the children who need services won't get them," Rodman said. "Fortunately, clinicians and physicians and the public around the world are still going to refer to Asperger's as Asperger's. It's like saying people don't have a right arm anymore.

"Many people with Asperger's are [also] concerned there will be a stigma -- that everyone will be considered autistic -- and when people think of that they think of a child sitting in a corner and spinning," Rodman added.

Changes made to the diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD). Critics are concerned that changes made to better diagnose ADHD will instead lead to over-diagnosis. In the previous version of the DSM, a person needed to show the onset of symptoms before age 7 to be diagnosed with ADHD. The new version now says 12 is the latest age at which ADHD symptoms can manifest themselves. The DSM-5 also reduces the number of criteria needed to arrive at a diagnoses of adult ADHD from six to five.A new diagnostic category for children who are hostile or acting out. The DSM-5 includes a new category called disruptive mood dysregulation disorder, which would apply to children who have extreme irritability but fall short of the standards for bipolar disorder or depression. The category was created to deal with the upswing in bipolar diagnoses among children, but there is concern that some clinicians will label a simple childhood temper tantrum as a treatable mental illness.Breaking out obsessive-compulsive disorders into their own category. Obsessions such as hoarding, hair-pulling and skin-picking had been considered anxiety disorders, but in the DSM-5 they will have their own category. Critics are concerned that this change has more to do with reality television's recent focus on hoarders than with the need for a new category of mental illness.

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demotivated

Hey all am haifa 21 year old student

Started my weight loss journey again on 2 of June And I had a goal of losing 1 kg/ 2 lbs a week which means 4 kgs a month It's almost the end of the month and I only lost 2 kg :'( I feel so sick and tired of my self I don't know what's wrong with my body but I don't seem like I lose weight fast It's driving me crazy

I started at 82 and reached 79 after 3 MONTHS ! Why is my body resisting weight loss ?! Please help me


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Cancer Patients May Face Higher Bankruptcy Odds

News Picture: Cancer Patients May Face Higher Bankruptcy OddsBy Barbara Bronson Gray
HealthDay Reporter

WEDNESDAY, May 15 (HealthDay News) -- People diagnosed with cancer are almost three times more likely to declare bankruptcy than are those without the disease, a large new study suggests.

And younger people with cancer have up to five times higher bankruptcy rates compared to older patients with the disease, the researchers found.

Of almost 200,000 people with cancer in the study based in Washington state, about 2 percent filed for bankruptcy protection after being diagnosed. Of those who were not diagnosed with cancer, 1 percent filed.

Although the risk of bankruptcy for those with cancer is still relatively low, researchers said it is significant.

"Bankruptcy is such an extreme measure of financial distress, and we didn't include the other forms of financial difficulties people encounter," said Catherine Fedorenko, a study co-author and technical project coordinator at the Fred Hutchinson Cancer Research Center, in Seattle.

Whether people suffer substantial debt or have to go so far as to declare bankruptcy, their financial problems are likely to be stressful, said Karma Kreizenbeck, a study co-author and project director at the Hutchinson Institute for Cancer Outcomes Research.

"This paper shows how medical debt associated with a cancer diagnosis could be more likely to lead to a bankruptcy," Kreizenbeck said. "But it could also mean people have to take second jobs, end up with lower credit scores or have to make other decisions."

Celeste Smith, 63, was diagnosed five years ago with breast cancer. A Seattle realtor who was just starting to do well in a new job, she found she had to stop working when she was faced with months of radiation and chemotherapy. Despite the fact that she had health insurance, her mortgage and car payment bills began to mount. "It's a horrible circle trying to get over cancer and deal with all the financial stress," she said. Smith ended up filing for bankruptcy and moving from her foreclosed house to affordable living for seniors.

Researchers have noted before that the financial burden on people with cancer can be substantial. Data from the Medical Expenditure Panel Survey in 2004 showed that 6.5 percent of the $20.1 billion spent on cancer care by those not yet on Medicare each year comes directly from the patients themselves, according to study background information.

A small study presented last year at an American Society of Clinical Oncology meeting showed that four of every five cancer patients and their spouses or caregivers said they had concerns about meeting medical costs and suffered associated financial and mental stress.

The new research, published online May 15 and in the June print issue of Health Affairs, is based on data taken from a registry of people 21 and older who lived in Washington and were diagnosed with cancer from 1995 through 2009. They were compared to a randomly sampled population of people without cancer, matched by age, gender and ZIP code. Cancer cases were identified using a cancer registry based at the Fred Hutchinson Cancer Research Center, part of a U.S. National Cancer Institute epidemiology database.

Key findings of the new study include the following:

Cancer patients were 2.65 times more likely than people without cancer to go bankrupt.Those cancer patients who filed for bankruptcy were more likely to be younger, female and nonwhite than were cancer patients who didn't file. The youngest age groups had up to 10 times the bankruptcy rate compared to the older age groups. The youngest groups in the study were diagnosed at a time when their debt was typically high and their income was not, the study noted. Bankruptcy filings went up as time went by. While the proportion of cancer patients who filed for bankruptcy within one year of diagnosis was 0.52 percent, it went up to 1.7 percent after five years. Bankruptcy rates were highest for people with the diagnosis of thyroid and lung cancer, and lowest for melanoma, breast and prostate cancer. The authors suggested that the higher rate of bankruptcy associated with thyroid cancer was likely due to the fact that it affects younger women more often than do other cancers.

The study, based on data from 1995 to 2009, did not take into account the potential impact of the implementation of the Affordable Care Act (ACA) in 2010, an expert pointed out.

"The problem of bankruptcy was one thing the ACA was designed to address," said Peter Cunningham, a senior fellow and director of quantitative research at the Center for Studying Health System Change, in Washington, D.C.

Cunningham expressed concern that the researchers didn't note whether the cancer patients or the control participants had health insurance. "So we don't know how much of a difference having health insurance makes in terms of avoiding bankruptcy," he said. "It would have been nice to see what the impact of health insurance coverage is in being able to prevent bankruptcy and how many people lost their health insurance coverage because of their cancer diagnosis."

What should people do to avoid the stress of money troubles when faced with a serious disease? "The study points to the value of having health insurance," Cunningham said.

MedicalNews
Copyright © 2013 HealthDay. All rights reserved. SOURCES: Catherine Fedorenko, technical project coordinator, Fred Hutchinson Cancer Research Center, Seattle; Karma Kreizenbeck, project director, Hutchinson Institute for Cancer Outcomes Research, Seattle; Peter J. Cunningham, Ph.D., senior fellow and director of quantitative research, Center for Studying Health System Change, Washington, D.C.; Celeste Smith, Seattle; June 2013, Health Affairs



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Cara Delevingne: "I want tattoos all over my body!"

Cara Delevingne: "I want tattoos all over my body!" - celebrity news (Glamour.com UK) GlamourSearch Glamour Dos & Don'ts Style Dos and Don'ts Hair Dos and Don'ts Celebrity Celebrity News Pics Just In! Celebrity Galleries Entertainment Celebrity A-Z GLAMOUR TV Quizzes Festivals Sexiest Men GLAMOUR Awards Fashion Style Tribe Shopping Celebrity Fashion Who Wore It Best? Street Style Style Jury Weddings Fashion News New Trends Catwalk Show Photos Fashion Week Beauty & Hair Hair & Hairstyles Beauty News A-List Hair & Beauty Beauty Features Get the Look GLAMOUR Apps Spas & Salons Life, Love & Sex Sex & Relationships Health & Fitness Living & Travel Horoscopes GLAMOUR Diets Love Calculator The Oracle Quizzes The Detox Bible Features Magazine The GLAMOUR List Subscribe To GLAMOUR Covers 2001-13 The Beauty Desk GLAMOUR Careers Ts and Cs Glam Happenings Digital Edition Competitions Best Dressed Comp May Beauty Giveaway Join In Newsletters Twitter Facebook GLAMOUR Apps Meet The Team //$('.adLeaderboard .no-ad,.adLeaderboard img[src$=817-grey.gif]').closest('.adLeaderboard').hide(); PushDownAd.init("http://ad.uk.doubleclick.net"); /* var PUSHDOWNAD = window.parent.EXPANDABLEAD || {}; PUSHDOWNAD.registerExpansion = function (expansionUrl) { PUSHDOWNAD.register(document.getElementById('PushDownHeaderImage'), expansionUrl); }; PUSHDOWNAD.writeHeader = function (cardImageSrc) { document.write("\"\""); }; PUSHDOWNAD.writeExpansion = function (expansionUrl) { document.write(""); }*/ Glamour Celebrity Celebrity News Cara Delevingne: "I want tattoos all over my body!" Celebrity News Cara Delevingne: "I want tattoos all over my body!" By Rebecca Cox Friday, 17 May 2013 Tweet Cara Delevingne: Getty Images Just days after showing off herfirst tattoo, Cara Delevingne has well and truly caught theink bug. 

Speaking at a party in Cannes lastnight, the supermodel revealed to GLAMOUR that shedoesn't intend to stop at the small lion tattoo on her left indexfinger. 

She toldus: "I want loads more. All over mybody!"

But you won't catch Cara in aUK tattoo parlour any time soon.

"I wouldn't go anywhere but BangBang in New York," she  continued. "Rihanna recommended me, and I'll definitely begoing back."

Other A-list clients at thefamous New York-based parlour include Cara's 'wifey' Rita Ora,Nicole Scherzinger and Justin Bieber. 

« Back to more Celebrity News Related stories Street Style Photoblog - Cathy Mee, Law Student Cathy Mee, Law Student Read more » Cara Delevingne returning home - celebrity news Cara Delevingne returning home Read more » Cara Delevingne on the street in New York - celebrity fashion Cara Delevingne on the street in New York Read more » Previous Next Vote Do-Vote » Don't-Vote » Bored-Vote » Inspired-Vote » In love!-Vote » Share Your Vote Facebook» Twitter» Add your comments Your name
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If there’s anyone that can teach the contestants a thing or two about singing, it’s Jessie J, seen here busting a high note in a revealing tropical print playsuit and a super-short ice blonde ‘do. »

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I need a buddy!

28 yrs old medium build 9 months post partum. Gained way too much weight while pregnant!! I weigh about 170lbs now and am looking to get down to 128. I'm also currently breastfeeding. Anyone in a similar shaped boat?

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FDA: Lower Ambien's Dose to Prevent Drowsy Driving

Blood levels from nighttime dose of sleep aid can remain too high the next morning, agency saysBlood levels from nighttime dose of sleep aid can

By Amanda Gardner

HealthDay Reporter

WEDNESDAY, May 15 (HealthDay News) -- The U.S. Food and Drug Administration has approved new, lower-dose labeling for the popular sleep drug Ambien (zolpidem) in an effort to cut down on daytime drowsiness that could be a hazard while performing certain tasks such as driving.

The move follows the FDA's request to manufacturers in January that drugs containing zolpidem carry instructions that lower the recommended dose and provide more safety information to patients.

"FDA has approved these changes because of the known risk of next-morning impairment with these drugs," the agency said in a statement released Tuesday on its website.

Sleep medications containing zolpidem include Ambien, Ambien CR, Edluar and Zolpimist, as well as generic versions of Ambien and Ambien CR.

"The purpose of the lowering is to help decrease the risk of next-morning impairment of activities that require alertness," Dr. Ellis Unger, director of the Office of Drug Evaluation I at the FDA's Center for Drug Evaluation and Research, said at the time of the agency's request to manufacturers. "We're particularly concerned about driving. A large fraction of the population drives and driving is an inherently dangerous activity."

Lowering the nighttime dose means there will be less residual drug in the blood by the time the person wakes up. Extended-release forms of the drugs tend to stay in the body longer, the FDA said.

The FDA has told manufacturers that recommended doses for women should be cut in half, from 10 milligrams to 5 milligrams for immediate-release products (Ambien, Edluar and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR).

For men, the agency has asked manufacturers to change the labeling to recommend that doctors and other health-care professionals consider prescribing lower doses, meaning 5 mg for immediate-release products and 6.25 mg for extended-release products.

In explaining the different recommendations for men and women, Unger said that "women appear to be more susceptible to risk for next-morning impairment because they eliminate zolpidem from their bodies more slowly."

It's not clear why women eliminate the substance from their bodies more slowly than men.

Although there have been reports of adverse events, including motor vehicle accidents possibly related to zolpidem, the link has not and probably cannot be definitely established, Unger said.

The changes were spurred by new driving-simulation studies showing that currently prescribed levels of drugs containing zolpidem may be high enough to impair alertness the next day, he explained.

The FDA will be requiring driving-simulation studies for new sleep medications, and it is assessing other insomnia medications on the market. Eventually, Unger said, "we want driving data on all sleep medications."

Unger emphasized that next-day impairment is not limited to medications containing zolpidem but to all sleep medications.

"For all sleep medications, doctors should prescribe and patients should take the lowest dose," he said.

People taking any kind of sleep medication should not change their dose without first talking to their health-care professional, he stressed.


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