FDA: Lower Ambien's Dose to Prevent Drowsy Driving

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.

Copyright © 2013 HealthDay. All rights reserved. SOURCES: May 14, 2013, news release, U.S. Food and Drug Administration; Feb. 14, 2013, statement, FDA; Jan. 10, 2013, news conference with Ellis Unger, M.D., director, Office of Drug Evaluation I, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

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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 says

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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How Estrogen May Help Prevent Urinary Tract Infections After Menopause

Laboratory study suggests vaginal supplementation would benefit some women

By Serena Gordon

HealthDay Reporter

THURSDAY, June 20 (HealthDay News) -- Estrogen treatment delivered vaginally may help prevent repeat urinary tract infections in postmenopausal women, new laboratory research suggests.

Urinary tract infections are common among women, with one-quarter experiencing recurring infections. And age-related changes increase the likelihood of these infections developing after menopause, when estrogen production plummets.

Until now, taking antibiotics prophylactically -- to ward off recurrent urinary tract infections -- has been the gold standard for these women, said Thomas Hannan, a research instructor in pathology and immunology at Washington University School of Medicine in St. Louis. "But antibiotic resistance is increasing, and some women are resistant to everything we have," Hannan said. "We need other options. We need non-antibiotic options."

This study, published in the June 19 issue of the journal Science Translational Medicine, "suggests a more holistic approach by changing the way women respond to bacteria," said Hannan, co-author of an editorial accompanying the study in the journal.

The results support the use of vaginal estrogen as a preventive measure for postmenopausal women with recurrent urinary tract infections, he wrote in the editorial.

Working in the laboratory and with animal models, the researchers identified a number of ways that estrogen -- the female sex hormone -- helps keep recurrent urinary tract infections at bay.

"This study presents some underlying mechanisms for the beneficial effect of [topical estrogen formulations] after menopause and supports the application of estrogen in postmenopausal women suffering from recurrent UTIs," wrote the study's authors, from the Karolinska Institute in Stockholm, Sweden.

About half of all women will experience at least one urinary tract infection in their lifetime, according to the study. For about 25 percent of these women, the infection will come back again within six months.

Low estrogen levels have previously been linked to recurrent infections, and the new study sought to identify exactly how estrogen might affect a woman's risk of recurrent urinary tract infections.

For the study, the researchers used human cells from postmenopausal women who had used supplemental vaginal estrogen for two weeks. They also worked with mice that were given bacteria that would cause urinary tract infections like those in humans.

They found that estrogen encourages production of natural antimicrobial substances in the bladder. The hormone also makes the urinary tract tissue stronger by closing the gaps between cells that line the bladder. By gluing these gaps together, estrogen makes it harder for bacteria to penetrate the deeper layers of the bladder wall, the study authors said.

Estrogen also helps prevent too many cells from shedding from the top layers of the bladder wall.

"Normally, there's an innate response to infection and some cells die -- sort of taking one for the team -- and then these cells shed," Hannan said. "But shedding too much could allow bacteria to get into the deeper tissue, so this exfoliation is a double-edged sword."

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Iron Supplements May Prevent Anemia During Pregnancy

The benefits also include improved birth weights, analysis shows

By Robert Preidt

HealthDay Reporter

FRIDAY, June 21 (HealthDay News) -- Taking iron supplements during pregnancy reduces women's risk of anemia and is linked with an increase in birth weight and a reduced risk of low birth weight, a new analysis finds.

Researchers examined more than 90 studies that included a total of nearly 2 million pregnant women and found that daily iron supplements significantly reduced women's risk of anemia during pregnancy.

Anemia during the first or second trimester was associated with a significantly higher risk of low birth weight and preterm birth, according to the study, which was published online June 20 in the journal BMJ.

In addition, the investigators found that for every 10 milligram increase in iron dose per day (up to 66 mg), mothers had a 12 percent lower risk of anemia, birth weight increased by 15 grams and the risk of low birth weight fell by 3 percent.

The World Health Organization recommends that pregnant women take 60 mg of iron per day, the study authors noted in a journal news release.

They also said iron deficiency is the most common nutritional deficiency in the world, and the most common cause of anemia during pregnancy, particularly in low- and middle-income countries. It is estimated that iron deficiency affected 32 million pregnant women worldwide in 2011.

"Our findings suggest that use of iron in women during pregnancy may be used as a preventive strategy to improve maternal [blood] status and birth weight," Batool Haider, of the departments of epidemiology and nutrition at Harvard School of Public Health in Boston, and colleagues wrote.

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Are there exercises I can do to strengthen my weak ankles and prevent sprains?

Posted June 15, 2013, 2:00 am

I tend to sprain my ankle fairly often. Are there any exercises that could help me strengthen my ankles and prevent future sprains?

Your ankles are remarkable joints. They must bear the full weight of your body, yet stay nimble and flexible. Every step, every jump, every move puts your ankles through a surprising range of motion. Even when you stand quietly, your ankles are constantly making minute adjustments to help you stay balanced.

Your central ankle bone is called the talus. Your shin bone, the large bone in your lower leg, connects to the talus. A second, smaller bone in the lower leg ends alongside the talus. Bracketed by two bony bumps (each called a malleolus) on either side of the ankle, the talus acts as a hinge that allows you to point and flex your foot.

Two other joints on the talus permit sideways movements. Two ligaments (the strong, usually inelastic, tissue that bind joints) link the inner malleolus to the ankle bones. Three more ligaments bind the outer malleolus to the talus and heel bone. Ligaments play an important role in ankle anatomy — and ankle sprains.

Ankle sprains occur when you roll your foot inward or outward, or turn or twist an ankle. Probably the most common cause of an ankle sprain is when your foot comes down on the floor or ground, and instead of landing on the sole of the foot you land on the outer edge of the foot. The force of your weight on the outer edge puts a great strain on the ligaments of the outer part of your ankle.

That stretches, or even tears, the ligaments that keep the bones and joints properly positioned. Depending on the force applied as you land, the sprain can be mild, moderate or severe.

The same injuries that cause ankle sprains can also cause ankle fractures. It can be hard even for your doctor to determine if you’ve broken a bone just by examining your ankle; an X-ray often is needed. Weak ankles not only have a tendency toward repeated sprains; they also are more easily fractured.

Weak ankles often can be traced to repeated sprains that loosen the ligaments — and loose ligaments increase the risk of future ankle sprains. It’s a vicious cycle.

However, loose ligaments are not the only reason ankles have a tendency to suffer from sprains. Weakness of muscles that support the ankle also make sprains more likely. That’s where exercises come in.

You’re likely to benefit from an ankle workout that incorporates strength exercises and stretches. These exercises will help you increase flexibility in your ankles and build up ankle-supporting muscles.

If possible, work with a physical therapist. He or she can design an individualized program to meet your needs. In the meantime, I’ve put a few ankle-strengthening exercises below.

Reps: 1 per leg

Sets: 1–3

Intensity: Moderate to hard

Hold: 60 seconds

Rest: 30–90 seconds between sets

Starting position: Stand up straight with your feet hip-width apart.

Movement: Lift your right foot a few inches off the floor, bending your knee slightly, and balancing on your left leg. Hold for 60 seconds, then lower your foot to the starting position. Repeat with your left leg. This completes one set

Tips and techniques:

Maintain neutral posture with your shoulders down and back.Tighten the muscles around your hips and buttocks for stability.Keep your abdominal muscles contracted.Too hard? Hold on to a chair or counter for support, or perform for less than 60 seconds.

Too easy? Stand on a soft mat to make it more difficult to balance.

Reps: 10

Sets: 1–3

Intensity: Light to moderate

Tempo: 3-1-3

Rest: 30–90 seconds between sets

Starting position: Stand up straight with your feet hip-width apart and your hands at your sides.

Movement: Slowly lift up on your toes so that your heels rise off the floor as high as possible. Pause, then slowly return to the starting position.

Tips and techniques:

Maintain neutral posture with your shoulders down and back.Stand evenly on your toes and heels before lifting and when returning to the starting position.Exhale as you lift.Too hard? Hold on to a chair or counter for support.

Too easy? Hold weights (3 to 5 pounds) in your hands while doing the exercise.

Reps: 10 front, 10 side-to-side

Sets: 1–3

Intensity: Light to moderate

Tempo: 1-1

Rest: 30–90 seconds between sets

Starting position: Stand up straight with your hands on your hips and your feet hip-width apart. Move your right foot forward so the right heel is in line with the toes of your left foot.

Movement: This is a two-step exercise.

Step 1: While keeping your heel grounded on the floor, lift the toes of your right foot as high as you can and tap them on the floor 10 times.

Step 2: Still keeping your heel grounded, lift up the toes of your right foot, then tap in and out (to the left and right) 10 times. Repeat both steps with your left foot. This completes one set.

Tips and techniques:

Maintain neutral posture with your shoulders down and back.Keep toe taps smooth and controlled.Too hard? Perform the exercise while seated in a chair with both feet on the floor.

Too easy? Secure a 1- to 3-pound ankle weight around your foot behind the toes.

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After a Prediabetes Diagnosis: How to Prevent Diabetes

What to do to stop prediabetes from becoming diabetes.

Getting diagnosed with prediabetes is a serious wake-up call, but it doesn't have to mean you will definitely get diabetes. There is still time to turn things around.

“It’s an opportunity to initiate lifestyle changes or treatments, and potentially retard progression to diabetes or even prevent diabetes,” says Gregg Gerety, MD, chief of endocrinology at St. Peter’s Hospital in Albany, N.Y.

Making these seven changes in your daily habits is a good way to start.

Becoming more active is one of the best things you can do to make diabetes less likely.

If it's been a while since you exercised, start by building more activity into your routine by taking the stairs or doing some stretching during TV commercials, says Patti Geil, MS, RD, author of What Do I Eat Now?

“Physical activity is an essential part of the treatment plan for prediabetes because it lowers blood glucose levels and decreases body fat,” Geil says.

Ideally, you should exercise at least 30 minutes a day, five days a week. Let your doctor know about your exercise plans and ask if you have any limitations.

If you're overweight, you might not have to lose as much as you think to make a difference.

In one study, people who had prediabetes did 30 minutes a day of moderate exercise and lost 5% to 7% of their body weight (just 10-14 pounds in someone who weights 200 pounds) cut their chances of getting diabetes by 58%.

See your doctor every three to six months, Gerety says. 

If you're doing well, you can get positive reinforcement from your doctor. If it's not going so well, your doctor can help you get back on track. 

"Patients like some tangible evidence of success or failure," Gerety says.

Load up on fruits and vegetables, especially the less-starchy kinds such as spinach, broccoli, carrots, and green beans. Add more high-fiber foods into your day. Choose whole-grain foods instead of processed grains -- for example, brown rice instead of white rice.

Also, swap out high-calorie foods. “Drink skim milk rather than whole milk, diet soda rather than regular soda,” Geil says. “Choose lower-fat versions of cheese, yogurt, and salad dressings.”

Instead of snacking on high-fat, high-calorie chips and desserts, choose fresh fruit, or whole wheat crackers with peanut butter or low-fat cheese, Geil says.  

Not getting enough sleep  regularly makes losing weight harder, says Theresa Garnero, author of Your First Year With Diabetes.

A sleep shortfall also makes it harder for your body to use insulin effectively and may make type 2 diabetes more likely.

Set good sleep habits. Go to bed and wake up at the same time every day. Relax before you turn out the lights. Don't watch TV or use your computer or smartphone when you're trying to fall asleep. Avoid caffeine after lunch if you have trouble sleeping.

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Switch to Skim Milk Won't Prevent Toddler's Obesity: Study

Title: Switch to Skim Milk Won't Prevent Toddler's Obesity: Study
Category: Health News
Created: 3/18/2013 8:35:00 PM
Last Editorial Review: 3/19/2013 12:00:00 AM

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Breast-Feeding Won't Prevent Pre-Teen Obesity, Study Finds

Nursing exclusively has no effect on later weight, but many other benefits exist

By Serena Gordon

HealthDay Reporter

TUESDAY, March 12 (HealthDay News) -- Breast-feeding has many benefits, but preventing overweight and obesity later in a child's life probably isn't among them, according to a new study.

The study included nearly 14,000 children from Belarus whose mothers were involved in a study to promote exclusive breast-feeding for longer periods. When the researchers checked on the children around age 11, they found that breast-feeding duration and exclusivity didn't make a difference in child's later weight.

Still, the study authors pointed out that breast-feeding has many advantages, and mothers should still be encouraged to breast-feed their infants.

"Although breast-feeding is unlikely to stem the current obesity epidemic, its other advantages are amply sufficient to justify continued public health efforts to promote, protect and support it," said the study's lead author, Richard Martin, a professor of clinical epidemiology at the University of Bristol in England.

Results of the study appear in the March 13 issue of the Journal of the American Medical Association.

The children in the study were initially recruited with their mothers for a study designed to assess a breast-feeding intervention program. The breast-feeding program was based on the World Health Organization/Unicef Baby-Friendly Hospital Initiative, which promotes exclusive breast-feeding and breast-feeding for longer periods of time.

Some of the practices included in the breast-feeding program included having a written breast-feeding policy, showing mothers how to initiate and maintain breast-feeding, having babies in the same room as their mothers 24 hours a day, and giving no pacifiers to the infants, Martin said.

The study included 31 hospitals in Belarus, a country in eastern Europe. Infants and their mothers were randomly selected to be in the breast-feeding-promotion group or in a group given the hospital's usual care.

The intervention substantially increased the duration of exclusive breast-feeding, according to the study. At 3 months, 43 percent of women in the intervention group were exclusively breast-feeding their babies, compared to 6 percent of those in the usual-care group. At 6 months, about 8 percent of women from the breast-feeding-program group were still breast-feeding exclusively, versus less than 1 percent of the usual-care group.

Although some previous studies suggested that breast-feeding exclusively for longer periods might curb childhood obesity, the researchers found no significant differences in body mass or in the risk of overweight or obesity when they followed up with the children about 12 years later, according to the study.

Dr. Deborah Campbell, director of the division of neonatology at Montefiore Medical Center in New York City, said she doesn't think this study is the final word on whether breast-feeding might affect later weight.

Campbell noted that, unlike a U.S. population, which would be more diverse, most of the people in Belarus have the same ethnic and racial background. They also have universal health care, and a population with higher education levels than the United States. These differences make it difficult to translate these findings to a U.S. population, she said.

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Health Tip: Help Prevent Constipation

Title: Health Tip: Help Prevent Constipation
Category: Health News
Created: 2/22/2013 8:35:00 AM
Last Editorial Review: 2/22/2013 12:00:00 AM

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High-Antioxidant Diet May Not Prevent Stroke, Dementia, Study Finds

By Carina Storrs

HealthDay Reporter

WEDNESDAY, Feb. 20 (HealthDay News) -- Antioxidants are celebrated as "brain foods" and "super foods," but a new study suggests that not all diets high in antioxidants reduce the risk of dementia and stroke.

The study involved more than 5,000 people in the Netherlands who were 55 years and older. Researchers determined each participant's antioxidant score, based on questionnaires about the foods they typically ate, and kept track of whether they developed dementia or had a stroke over the next 14 years.

"We asked, 'Is the [measure] of total antioxidant levels the important predictor for dementia and stroke, irrespective of what foods are contributing?'" said Elizabeth Devore, an instructor in medicine at Harvard Medical School in Boston and lead author of the study.

Although the study did not find lower rates of dementia and stroke among people with antioxidant-rich diets, similar research in other populations has come to different conclusions. For example, a study of older Italian adults found that higher antioxidant levels were linked to lower stroke risk.

The difference between the Dutch and Italian groups could lie in the types of antioxidants they eat, Devore said.

Almost 90 percent of the variability in antioxidant levels among the Dutch participants was due to coffee and tea consumption, whereas the antioxidants in the Italian cohort came largely from eating fruits and vegetables.

"There's a lot of [studies] to suggest that higher fruit and vegetable intake is associated with lower risk of stroke," Devore said. "It is possible that, though the Italian study did report diet antioxidant score, that is really being driven by those specific foods."

"It is not about total antioxidant level, it is about specific antioxidant-rich foods," Devore added.

The research in the Dutch population was published Feb. 20 in the online issue of the journal Neurology.

"It's a little bit hard to interpret the finding that total antioxidant capacity of the diet does not have a role, because of the abundance of evidence showing that oxidative stress [on cells] has a role in these diseases," said Gene Bowman, a nutritional epidemiologist at Oregon Health and Science University, in Portland.

However, "it may be that the antioxidants that they're capturing aren't the ones that are the big players," Bowman said.

Still, the idea of looking at total antioxidant capacity instead of individual antioxidant-rich foods is a new and important approach, he said.

"We've already had large observational studies showing us that certain antioxidants are linked to less stroke and dementia risk, but when giving these antioxidants in clinical trials to reduce risk for less stroke and dementia, the results have been disappointing," Bowman said.

The current study included almost 5,400 people who did not show signs of dementia and almost 5,300 people who had never had a stroke.

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Progesterone Shots May Not Prevent Preterm Birth of Twins: Study

Title: Progesterone Shots May Not Prevent Preterm Birth of Twins: Study
Category: Health News
Created: 2/14/2013 2:36:00 PM
Last Editorial Review: 2/15/2013 12:00:00 AM

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Health Tip: Help Prevent Norovirus

Title: Health Tip: Help Prevent Norovirus
Category: Health News
Created: 2/14/2013 8:35:00 AM
Last Editorial Review: 2/14/2013 12:00:00 AM

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Health Tip: Prevent Produce Problems

Title: Health Tip: Prevent Produce Problems
Category: Health News
Created: 2/12/2013 8:35:00 AM
Last Editorial Review: 2/12/2013 12:00:00 AM

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