October 2008


Oct. 31, 2008 -- A scientific panel has formally urged the FDA to rethink a recent conclusion that a chemical used in baby bottles and infant formula packing is safe at current levels.

The chemical, called bisphenol A (BPA), is an ingredient in hard plastics and in the lining of many food cans. Consumer and environmental groups and several foreign regulatory bodies have called for the chemical to be banned over concerns that it may pose a health risk.

BPA is a known toxin. But the vast majority of studies are in animals. That forces scientists in many cases to take studies in mice or rats and extrapolate the results to humans.

The FDA concluded in August that the levels humans typically consume are safe. Earlier this week, a scientific subcommittee rejected that view, saying the agency ignored several studies and that it was premature to declare the chemical safe for human consumption.

On Friday, a scientific advisory board signed off on that report, in effect urging the agency to reconsider its conclusion.

The agency has until February to officially respond to the report. But a response is likely to come more quickly than that, says Stephen Sundlof, PhD, director of the FDA's Center for Food Safety and Applied Nutrition.

"We don't feel like we have to wait until February," Sundlof tells WebMD.

The agency has not urged consumers to avoid BPA-containing bottles or stop buying formula packaged in cans containing the chemical.

Still, some of the panel's members urged the agency to take immediate steps limiting infants' exposure to BPA.

Panel member Larry Sasich of the Lake Erie College of Medicine School of Pharmacy says the FDA is "losing credibility with the public" by failing to take clear steps limiting BPA exposure. "They expect us to come up with some solutions to this problem," Sasich says.

The FDA -- although revisiting its assumptions about safe BPA levels -- is still not recommending any change in consumer behavior. The agency is concerned that switching away from formula could pose a nutritional risk to infants that outweighs any benefit of avoiding BPA.

"We're very concerned that mothers will find and create their own infant formula," he says.

Groups representing formula manufacturers and packaging companies maintain that BPA is safe.

"They're not saying this is an imminent risk. They're just saying FDA needs to revisit its process," says John M. Rost, CEO of the North American Metal Packaging Alliance.

Consumer groups have urged the FDA to warn the public against potential BPA dangers while it searches for more conclusive scientific data about its safety. A number of major retailers, including Wal-Mart and Target, have said they would stop selling baby bottles that contain bisphenol A.

"The FDA should not draw conclusions that are biased and premature," says Diana Zuckerman, PhD, president of the National Research Center for Women and Families. "While the FDA is deciding what to do about BPA in food containers, they should at the very least empower consumers by requiring that food and beverage containers list whether or not they contain BPA."

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SOURCES:

Stephen Sundlof, PhD, director, center for Food Safety and Applied Nutrition, FDA.

Larry Sasich, Lake Erie College of Medicine School of Pharmacy; member, FDA advisory panel.

John M. Rost, CEO, North American Metal Packaging Alliance.

Diana Zuckerman, PhD, president, National Research Center for Women and Families.

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Oct. 31, 2008 -- The FDA has approved a new prescription drug called Toviaz to treat overactive bladder (OAB) in adults.

Toviaz relaxes the bladder's smooth muscle tissue, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence that are characteristic symptoms of OAB.

"Patients who suffer from overactive bladder face quality of life issues that can hamper their ability to enjoy life to its fullest. This new drug will provide an additional treatment option to help them manage problems with an overactive bladder," George Benson, MD, says in a news release. Benson is the deputy director of the Division of Reproductive and Urologic Products at the FDA's Center for Drug Evaluation and Research.

Toviaz, which is taken once daily, will be available as an extended-release tablet in doses of 4 or 8 milligrams. The recommended starting dose is 4 milligrams, which can be increased to 8 milligrams if needed, based upon individual response and tolerability, according to the FDA.

The FDA approved Toviaz based on two studies, each lasting 12 weeks. Together, the studies included 554 patients who took either the 4-milligram dose, the 8-milligram dose, or a placebo. Toviaz trumped the placebo at reducing the number of times per day that patients leaked urine or needed to urinate.

According to the FDA, common side effects associated with Toviaz included dry mouth and constipation. Less frequently reported side effects included dry eyes and trouble emptying the bladder.

Toviaz doses higher than 4 milligrams aren't recommended for patients with severe reduction in kidney function or people taking medications, such as ketoconazole, that block metabolism of Toviaz.

Toviaz shouldn't be used by patients who suffer from urinary or gastric retention, patients with uncontrolled, narrow-angle glaucoma, or patients with severe liver impairment. Toviaz should be used with caution in patients who suffer from decreased gastrointestinal motility, such as those with severe constipation.

Consumers or health care professionals may report any side effects or product quality problems with Toviaz to the FDA's MedWatch Adverse Event Reporting program.

Toviaz is made by Schwarz Pharma of Zwickau, Germany, and is distributed by the drug company Pfizer.

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SOURCE:

News release, FDA.

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Oct. 31, 2008 -- Ever wonder why some people are more successful than others when it comes to weight loss?

It's not just about calories or logging time on the treadmill. It's also a matter of personality, experts told a packed conference hall of dietitians in Chicago for the annual meeting of the American Dietetic Association (ADA).

At the meeting, Robert Kushner, MD, MS, and Dawn Jackson Blatner, RD, described 21 personality types and how each personality approaches eating, exercise, and stress.

Those personality types are described in Counseling Overweight Adults: The Lifestyle Pattern Approach and Tool Kit, a book written for the ADA by Blatner, Kushner, and Kushner's nurse-practitioner wife, Nancy Kushner, MSN, RN. Blatner is an ADA spokeswoman. Robert Kushner is clinical director of the Northwestern Comprehensive Center on Obesity, a professor of medicine at Northwestern University's Feinberg School of Medicine, and the president-elect of the Obesity Society.

The new book is written for dietitians, not the general public. But it contains some insights that may have the ring of truth, even if you don't have "RD" after your name.

See if these personality patterns sound familiar -- and find out what to do about them.

The 7 Personality Patterns

In their book, the Kushners and Blatner list personality patterns that are common in overweight people who have problems losing weight for good.

Here are the seven personality patterns linked to eating:

  • Meal skipper: often skips meals
  • Nighttime nibbler: munches at night
  • Convenient diner: eats out often
  • Fruitless feaster: skimps on fruits and vegetables
  • Steady snacker: snacks a lot
  • Hearty portioner: eats big portions
  • Swing eater: swings between being a dietary "goody two-shoes" and then lapses

These are the seven personality patterns related to exercise:

  • Couch champion: a sedentary person (think couch potato)
  • Uneasy participant: feels self-conscious about exercise
  • Fresh starter: an exercise novice
  • All-or-nothing doer: "They'll be gung ho and then do nothing," says Blatner
  • Set routine: does the same exercise routine over and over
  • Tender bender: limited by aches and pains
  • Rain-check athlete: has good intentions that don't get realized

And here are the seven personality patterns related to coping with stress:

  • Emotional eater: Someone who turns to food when emotional
  • Self-scrutinizer: Someone with a negative self-image who's harsh on himself or herself
  • Persistent procrastinator: Someone who delays taking action
  • People pleaser: Someone who focuses so much on others that there's no time or energy left for his or her own health
  • Fast pacer: Someone who lives on the go, with too little time for a healthy lifestyle
  • Doubtful dieter: Someone who's tried to lose weight in the past and doubts he or she can succeed
  • Overreaching achiever: Someone who sets unrealistic goals and then gets discouraged

Using the Personality Patterns

If you're working with a dietitian, the first step is to complete a 50-question survey. Based on the answers, your dietitian can create a bar graph showing where you rank for each of the 21 personality types.

Using the Personality Patterns continued...

You could fit into more than one pattern per category. For instance, you might rank highest as a people pleaser and convenient diner in the eating category, as a couch champion and tender bender in the exercise category, and as an emotional eater and people pleaser in the coping category.

Next, you and your dietitian would tailor a weight and lifestyle plan that fits your personality profile. "The patient doesn't want a cookie-cutter approach," Blatner says. Because she's a believer in taking small, achievable steps toward goals, Blatner recommends tackling "one tricky lifestyle situation at a time."

Not working with a dietitian? Blatner suggests reviewing the 21 personality patterns and finding the two or three in each category that you identify with, and then look for ways to address those patterns.

For instance, a meal skipper could set a meal schedule, and an emotional eater could find other ways to handle their feelings. Blatner also recommends Dr. Kushner's Personality Type Diet, a book written for consumers several years ago by the Kushners.

Graph Your Weight History

Graphing your weight over time can also be helpful, Robert Kushner noted in his ADA speech.

Here's how: Take a blank sheet of paper and draw a horizontal axis for time and a vertical axis for weight, then chart what you've weighed since age 18, and put notes by the turning points.

For example, Robert Kushner recalls a patient whose graph showed weight gain in college, weight loss right before her wedding, regain during pregnancy and weight loss afterward, followed by more weight gain after being demoted at work. And a man graphed his yo-yo cycle of gaining weight on business trips, followed by bouts of exercise that didn't solve the problem, probably because he didn't address his diet, says Robert Kushner.

Why look back? Because hindsight may hold clues that could prove useful as you move forward.

Calories still count, but each person has his or her own path to reach a healthy weight, and it takes awareness about your past and your personality to find your unique path. That awareness may help you stay the course, and as Robert Kushner says, "The more adherent you are, the more likely you are to be successful."

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SOURCES:

Robert Kushner, MD, MS, clinical director, Northwestern Comprehensive Center on Obesity; professor of medicine, Northwestern University Feinberg School of Medicine; president-elect, the Obesity Society.

Dawn Jackson Blatner, RD, spokeswoman, American Dietetic Association.

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Oct. 31, 2008 -- Gaining 40 pounds or more during pregnancy nearly doubles the risk of having a baby who weighs 9 pounds or more, in turn increasing the health risks to mother and baby, according to a new study.

Excessive pregnancy weight gain and big babies have often been linked, says Teresa Hillier, MD, senior investigator at the Kaiser Permanente Center for Health Research, Portland, Ore., and the study's lead author. Researchers have also known that women who develop diabetes during pregnancy, called gestational diabetes, are more likely to deliver heavier babies, Hillier tells WebMD.

But the new study is believed the first to conclude that women who gain excessive weight during pregnancy are even more likely to have heavier babies than women treated for gestational diabetes who don't gain excess weight.

"More than one in five women gain too much weight during pregnancy and only 5% have gestational diabetes," Hillier tells WebMD. The study, she says, points to the need for all women to follow recommendations about not gaining excessive amounts of weight.

Pregnancy Weight Gain & Big Babies: Study Details

Hillier and her colleagues followed 41,540 women who gave birth to singleton babies in Washington, Oregon, and Hawaii from 1995 through 2003. They used patient medical records and birth certificates to note the mother's weight gain and the baby's birth weight.

All mothers-to-be were screened for gestational diabetes.

The researchers analyzed the numbers of women who gained more than 40 pounds -- the maximum recommended weight gain -- and whether their babies weighed more than about 9 pounds at birth, which is considered a heavy baby.

Heavier babies are at risk of becoming heavy adults, Hillier says, and make it more likely the mother will have to deliver by cesarean section, among other increased health risks.

Pregnancy Weight Gain & Big Babies: Study Results

Overall, 12.5% of the babies -- or 5,182 -- were born weighing 8.8 pounds or more.

Overall, more than 20% of those who gained more than 40 pounds gave birth to heavy babies, and less than 12% of those who gained less than 40 pounds had heavy babies.

Other results suggest that excess weight gain -- whether or not a woman has gestational diabetes -- boosts the risk of having a heavy baby.

  • While 16.5% of women with normal glucose who gained more than 40 pounds had a heavy baby, only 9.3% of those who had normal glucose levels who gained less than 40 pounds had a heavy baby.
  • While 29.3% of women with gestational diabetes who gained more than 40 pounds had big babies, just 13.5% of those with gestational diabetes who gained 40 pounds or less did.

"Gestational diabetes puts the baby in an overfed state," Hillier says. "When a mother gains too much weight, even if she has normal glucose levels, the baby is overfed in a similar way."

Big babies are also more likely to get stuck during vaginal deliveries, she says, and to be injured.

Pregnancy Weight Gain & Big Babies: Second Opinion

The study results confirm what physicians and researchers have suspected for a long time, says Richard Frieder, MD, an obstetrician-gynecologist at Santa Monica -- UCLA Medical Center and Orthopaedic Hospital in California, who reviewed the study for WebMD.

''It confirms the suspicion that weight gain makes a difference, whether you are diabetic or not," he says.

Among his pregnant patients, he says, misconceptions about the ideal weight gain during pregnancy are plentiful. "Many women think they need to gain a large amount to have a healthy baby," he says. In general, he advises patients to aim for a gain of 25 to 35 pounds if they are normal weight before getting pregnant.

"Most of the weight gain should come in the second half of pregnancy," he adds.

Ideally, he tells women, aim for a gain of just five to seven pounds in the first 20 weeks, then about 20 to 30 in the remaining weeks.

Pregnancy Weight Gain: Advice?

Recommendations issued by the federal Institute of Medicine in 1990, which are now being re-examined, advise weight gain amounts based on pre-pregnancy weights:

  • For women with a low body mass index or BMI, below 19.8, a gain of 28 to 40 pounds
  • For women with a normal BMI of 19.8 to 26.0, a gain of 25 to 35 pounds
  • For women with a high BMI, above 26, a gain of 15 to 25 pounds.

A report on the results of the re-examination of the recommendations is expected by June 2009.

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SOURCES:

Teresa Hillier, MD, senior investigator, Kaiser Permanente Center for Health Research, Portland, Ore.

Hillier, T. Obstetrics & Gynecology, November 2008, vol 112: pp 1007-1014.

Richard Frieder, MD, obstetrician-gynecologist, Santa Monica-UCLA Medical Center & Orthopaedic Hospital, Santa Monica, Calif.

Institute of Medicine: "Nutrition During Pregnancy."

Institute of Medicine: "Re-examination of IOM Pregnancy Weight Guidelines."

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Oct. 31, 2008 -- A woman's body fat may play a role in her bone mineral content after menopause, a new study shows.

The study, presented this week in Chicago at the annual meeting of the American Dietetic Association (ADA), shows that postmenopausal women with a higher proportion of body fat tend to have lower bone mineral content.

That may sound confusing, if you've heard that bigger people tend to have stronger bones. But size doesn't tell the whole story; body composition also matters, according to researcher Kathryn Piehowski, RD, of Pennsylvania State University.

The take-home message: "Weight is good for bone [but] keep it lean," Piehowski tells WebMD.

Piehowski studied 93 postmenopausal women (average age: 57). The women got high-tech body scans and had their height and weight measured.

Bone mineral content was better for women on the leaner side -- those with a lower proportion of body fat -- compared to women with a higher proportion of body fat.

The reason for that isn't clear from this study, but Piehowski notes that having a high proportion of body fat is associated with greater inflammation, which may increase bone breakdown.

None of the women in Piehowski's study had osteoporosis (dangerously weak bones) or osteopenia (weak bones that aren't as weak as osteoporotic bones). But it's not clear if any of the women would eventually get osteoporosis or osteopenia, since the study was a snapshot in time without long-term follow-up.

Keep in mind that a person's body composition isn't always obvious. For instance, a large person who's all muscle may not have a lot of excess body fat, while someone who looks slim may not have a lot of muscle.

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SOURCES:

Kathryn Piehowski, RD, Pennsylvania State University.

American Dietetic Association Food & Nutrition Conference & Expo, Chicago, Oct. 25-28, 2008.

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