FDA Panel Urges Restrictions on 2 Asthma Drugs

FDA Panel Urges Restrictions on 2 Asthma Drugs
Serevent, Foradil Inhalers Should Not Be Used Alone, Experts Urge
By Todd Zwillich
Michael W. Smith, MD

Dec. 11, 2008 - An expert panel said Thursday that the benefits of two inhaler drugs are not worth the risks and should no longer be used to treat asthma.

The vote does not mean the two drugs, Serevent and Foradil, will be pulled from the market. Instead, the panel strongly urged the FDA to tell doctors not to prescribe the drugs to children or adults as a standalone asthma treatment.

The drugs are also widely prescribed for chronic obstructive pulmonary disease. That use was not affected by Thursday's deliberations of a 27-member FDA advisory committee.

At the same time, the experts backed two other popular asthma drugs, saying their benefits outweigh their risks.

Serevent and Foradil are in a class of drugs known as beta-agonists. They help control and prevent airway spasms during asthma attacks. But the drugs have also been associated with a small but significant increase in the risk of hospitalization and death from asthma.

Medical guidelines and the drugs' labeling recommend that beta-agonists only be used in combination with inhaled steroids that cut down on airway inflammation leading to attacks. The combination lowers the risks to a level most experts believed is justified by their benefits.

But studies show that many patients do not use inhaled steroids as directed when taking them separately from beta-agonists. At the same time, patients often feel physical relief from labored breathing when they use their beta-agonist inhaler. The difference can lead to many patients using the beta-agonist alone (called monotherapy), which raises the risk of dangerous side effects, according to FDA analyses presented this week.

"I think the label should be greatly strengthened to say that monotherapy for asthma should basically be contraindicated" for Serevent and Foradil, said Daniel Notterman, MD, a member of the advisory panel from the department of molecular biology at Princeton University.

The rest of the advisors agreed. In a 17-to-10 vote, the panel said the risks of long-term Serevent and Foradil use outweigh the benefits when used alone. The panel cast a similar vote for adolescents with asthma and voted unanimously that the drugs are not worth the risk in children 4 to 11 years old.

"The data is that single use is dangerous," said David Schoenfeld, PhD, a panelist and professor of medicine from Massachusetts General Hospital.

The panel gave broad backing to two other asthma drugs, Advair and Symbicort, in adults. Those products contain a combination of beta-agonist and steroid drugs, thus guaranteeing that patients get both drugs each time they take a puff.

The group was split on whether Advair should be used in children. Thirteen panelists said Advair's benefits outweigh its risks in children, while 11 said they did not. Three abstained.

Experts said they were uneasy with how few studies had been performed showing Advair's safety and efficacy in children.
"I think there's a paucity of data," Notterman said.

Symbicort is generally not used in children.

John Jenkins, MD, who heads FDA's Office of New Drugs, said the agency would consider ordering manufacturers to conduct more safety studies in children, which it can do under new authority granted by Congress.

Ellen Strahlman, MD, the chief medical officer of GlaxoSmithKline, which makes both Advair and Serevent, said the company was pleased with the committee's backing of Advair. But she also said the company was "concerned" that the panel's vote to restrict Serevent could "deny patients needed treatment for optimal care of their asthma."

A statement from Novartis and Schering-Plough said the companies "strongly disagree" with the panel's rejection of Foradil, which they market in a joint venture.

"We believe this opinion is inconsistent with clinical evidence supporting the benefit/risk profile of Foradil in patients not adequately controlled on other asthma-controller treatments," the statement read.

The FDA now has to go back and consider whether to change product labeling or indicated uses for Serevent and Foradil. It will also consider ordering new safety studies, Jenkins said.

Jenkins emphasized that patients currently taking Serevent or Foradil "should not stop taking your asthma medications without talking to your physician."
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SOURCES:

Daniel Notterman, MD, department of molecular biology, Princeton University; member, FDA advisory panel.

David Schoenfeld, PhD, professor of medicine, Massachusetts General Hospital; member, FDA advisory panel.

John Jenkins, MD, director, FDA Office of New Drugs.

Ellen Strahlman, MD, chief medical officer, GlaxoSmithKline.

News release, Novartis Pharmaceuticals Corp. and Schering-Plough

21 Look-Great Shortcuts

21 Look-Great Shortcuts
By Leesa Suzman
Expert tips, tricks, and products - most under $10 - to save you 50+ valuable minutes, morning and night.

Maybe you were having a dream about George Clooney that continued, thrillingly, well past the trilling of your alarm clock. Or perhaps your kids begged you to make homemade pancakes (which left you with three minutes to get the flour out of your hair, and no time for concealer). When your day feels like a mad dash instead of a walk in the park, these tweaks to your morning routine, shower, and bedtime prep can help you at least appear to have your life under control. If you've ever wished you could squeeze a few more minutes out of your busy day, now you can.
Morning-Rush Makeover

Yikes! You overslept, and now you have to get ready and out the door at warp speed. These tips eliminate almost an hour of prep time — and you'll still emerge looking fresh and pulled together.

Instead of: A time-consuming shower
Speedy solution: Splash cold water or spray a hydrating mist on your face to energize your skin. Store the mist in the fridge, or quickly run it under the tap; it will feel more invigorating as it hits your complexion. "Cold water instantly tones and tightens your skin," says Ann Marie Cilmi, director of education and development at Bliss. Try The Body Shop Vitamin C Energizing Face Spritz. Minutes saved: 10

Instead of: Multistep skin prep
Speedy solution: Jump right to moisturizing. Skip cleanser and toner, and give yourself more even-toned, hydrated, and protected skin by slathering on a tinted moisturizer with SPF. "Go over any discolored areas a second time," says Blair Patterson, a global makeup artist for Estée Lauder. You can also add another layer to cheekbones to help contour the face when it's puffy from sleep. Try CoverGirl Aqua Smoothers Tinted Moisture SPF 15. Minutes saved: 5

Instead of: Elaborate eye makeup
Speedy solution: Stick with three express moves. Tame brows, apply highlighter, and slick on black mascara. You can quickly smooth unruly brows using a brow gel or a pencil-and-comb combo such as Prestige Browliner. Then add a pop of white or bone shimmer shadow just below the browbone. "It draws attention upward and gives your face a more awake, lifted look," says Ramy Gafny, a New York City celebrity makeup artist. Finish by applying black mascara from the base to the tips of lashes to give them maximum length. Minutes saved: 10

Instead of: Blush and lipstick and shadow
Speedy solution: Choose one triple-duty product. A creamy blush that also works on lips and lids is ideal. Whatever you do, don't skip blush; makeup artists say it's the most underrated beauty product for waking up the face. Just smile and use the heat of your fingers to dab color on the rounds of your cheeks and across your lips, suggests Marcia Kilgore, creator of Soap & Glory. Use the same shade to brighten lids. Try E.L.F. All Over Color Stick in Persimmon. Minutes saved: 5

Instead of: A styling marathon
Speedy solution: Stash your blow-dryer and brush, and try some quick "detailing." Pull slept-on hair back into the Tonytail, a faux-hair ponytail holder that creates the illusion your strands have been expertly wrapped around the base of the pony. Or give a cropped style instant polish by smoothing out bangs and short layers with one of the new purse-size flattening irons. "It's easier to control than a full-size version and costs less," says Joelle Dunrovich, a hairstylist at Rita Hazan Salon in New York City. Try Slik Stik Mini. Minutes saved: 20-plus
The Ultimate Time Saver

Surprise! It's beauty sleep. You may be off in dreamland, but your skin is working overtime. "Inflammation is down and stress hormones reach their lowest levels by the middle of the night," says Amy Wechsler, M.D., a New York City dermatologist. This relaxed state can improve breakouts, fine lines, dark circles — the works. Here's how to boost your looks while your body rests.

Take years off your face: "Nothing works better at night to prevent and correct wrinkles than a topical retinoid," says Doris J. Day, M.D., clinical assistant professor of dermatology at NYU Medical Center. With regular use, this potent antiaging ingredient helps speed cell turnover and ratchet up collagen production, so you awake with smoother, more radiant skin. If a prescription retinoid is too harsh for your skin, try retinol, a gentler, over-the-counter cousin. (We like Roc Retinol Correxion Deep Wrinkle Night Cream.) Since they both can dry out skin, layer a hydrating lotion or cream over serums containing either ingredient (but wait five minutes to let the active ingredient sink in).

Slough off the rough spots: Slather on a body cream laced with glycolic acid before bed to loosen dead skin. Try Lubriderm Advanced Therapy Triple Smoothing Body Lotion. Apply a second layer to extra-dry areas like feet, elbows, and hands. In the morning, use an exfoliating body wash to send those loosened cells down the shower drain.

Reduce puffiness: The flip side of all the good things that happen to your skin while you sleep? "Lying flat for hours causes fluid to accumulate in your face, especially around your eyes," says Dr. Wechsler. Minimize puffiness by keeping your head elevated on at least two pillows and skipping salty foods like sushi with soy sauce for dinner.

Get softer, shinier hair: Deep conditioning can rescue hair that lacks shine or softness. Still, most women don't have the time to sit still while a messy, goopy formula sinks into strands. Instead, look for hair masks meant for nighttime use. Try John Frieda Frizz-Ease Crème Serum Overnight Repair Formula, which is formulated to go on dry hair, so you won't have to sleep with a wet head. It's also lightweight enough not to leave residue on your pillow.

"Work" on your tan: Applying self-tanner before bed lets you wake up looking sun kissed and sidesteps the issue of its potentially unappealing scent. Most self-tanners contain DHA, which gives off the odor of uric acid for hours as the color develops. But if you apply it before bed, the smell will be gone by morning, explains Cilmi. (Just be sure the product no longer feels tacky when you hit the sheets.) An alternative: Try lavender-infused Olay Touch of Sun Overnight.
Makeup Multitaskers

Five cosmetic overachievers that save you time — and purse space — by offering at least three beauty benefits in one small package.

* Foundation + makeup brush + sun protection = Neutrogena Mineral Sheers Liquid Makeup SPF 20
* Nail file + cuticle softener + cuticle pusher = 5 Second 3-in-1 Manicure Pen
* Concealer + wrinkle smoother + sun protection = L'Oréal Paris Visible Lift Line-Minimizing & Tone-Enhancing Concealer SPF 20
* Eyebrow tamer + skin softener + blister blocker + more = Bliss Problem Salved 20-in-1 Wonder Balm

Lip gloss + tooth whitener + breath freshener = Tarte Enbrightenmint BriteSmile Whitener & Tarte Lipgloss
Speedier Showering

Could you get in and out any faster — and still emerge with clean, soft skin and hair, and a refreshed spirit? Absolutely, say the experts. Here are six ways to make your time under the spray deliver more.

1. Simplify sudsing: "Just focus shampoo on the roots instead of lathering up the whole head," suggests Cilmi. "As the shampoo slides down your hair shaft during the rinse, the rest of your hair will get clean." Quickly squeeze out the excess water before you put in conditioner to prevent diluting the moisturizing ingredients. Then you can leave conditioner in for less time.

2. Get a brighter smile: Stash an extra toothbrush and toothpaste in your shower caddy. "I'm a firm believer that brushing my teeth in the shower saves time," says Los Angeles aesthetician Angela Nice. Makeup artist Ramy Gafny swears by Arm & Hammer Whitening Booster, a peroxide gel you put on top of toothpaste to brighten teeth in a hurry.

3. Steam-clean your complexion: Slap on a hydrating facial mask to deep-clean your skin. The treatment ingredients will penetrate further when they work in conjunction with the shower's pore-opening steam. Try Clean & Clear Soft In-Shower Facial, and rinse after one minute.

4. Eliminate stubble: "Never shave dry," says Dr. Day. Instead, use a moisturizing body wash in conjunction with your razor to get your skin clean, soft, and stubble-free. Try Weleda Sea Buckthorn Creamy Body Wash. If you wax, lather up with an exfoliating wash that will help reduce ingrown hairs made worse by waxing. Try: Johnson's Softwash Gentle Exfoliating 24 Hour Moisturizing Wash. New Veet In Shower Hair Removal Cream features a water-resistant formula that stays put under the spray. After two minutes, whisk the depilatory cream away with the accompanying sponge.

5. Clear your cuticles: Once your hands have been in the water for a couple of minutes, use a washcloth to gently push back cuticles. Doing this every time you shower will prevent cuticle buildup, so your nails look clean and well cared for, even when you don't have time for regular manicures.

6. Smooth your soles: Sally Hansen La Cross Foot Smoothing Disk is a palm-size, easy-to-grasp disk with exfoliating ridges that remove dead skin as you slide it back and forth across your feet. For spa-worthy results, wait until the end of your shower, when the warm water makes skin easier to slough off. If you shower in a tub, plug the drain and sprinkle in some bath salts for an instantly soothing foot soak that will also help soften any rough spots on your soles.

The Truth About Belly Fat

The Truth About Belly Fat
What's the best way to trim your tummy?
By Kathleen M. Zelman, MPH, RD, LD

Having a flat belly or so-called "six-pack abs" is a dream of most adults. If you're middle-aged, have ever been pregnant, or sometimes indulge in too much food or one too many beers, you probably have a spare tire you'd like to get rid of. So what's the best strategy for banishing belly fat? Is it as simple as adding certain foods to your diet, or doing particular exercises?

WebMD turned to the experts for answers on belly fat -- and the best ways to lose it.
The Answer to Flatter Abs

Don't despair; you can lose that spare tire, experts say. But there's no secret formula.

"There is no magic bullet, diet plan, specific food, or type of exercise that specifically targets belly fat. But the good news is belly fat is the first kind of fat you tend to lose when you lose weight," says Michael Jensen, MD, a Mayo Clinic endocrinology specialist and obesity researcher.

Whether you're an "apple" shape with excess belly fat, or a "pear" with wide hips and thighs, when you lose weight, you'll most likely lose proportionately more from the abdominal region than elsewhere.

"Ninety-nine percent of people who lose weight will lose it in the abdominal region before anywhere else -- and will lose proportionately more weight from the upper body," says Jensen, also a professor of medicine.

And why is that? "Visceral fat, the kind tucked deep inside your waistline, is more metabolically active and easier to lose than subcutaneous fat under the skin, especially if you have plenty of it," explains Penn State researcher Penny Kris-Etherton, PhD, RD.

And the more weight you have to lose, the more quickly you're likely to start losing your belly fat, experts say.

"People who are significantly overweight may see quicker results in their belly than someone who has less to lose in that area, such as a postmenopausal pouch," says Georgia State University nutrition professor, Christine Rosenbloom, PhD, RD.
Can Whole Grains Help You Lose Belly Fat?

A recent study in the American Journal of Clinical Nutrition showed that a calorie-controlled diet rich in whole grains trimmed extra fat from the waistline of obese subjects.

Study participants who ate all whole grains (in addition to five servings of fruits and vegetables, three servings of low-fat dairy, and two servings of lean meat, fish, or poultry) lost more weight from the abdominal area than another group that ate the same diet, but with all refined grains.

"Eating a diet rich in whole grains while reducing refined carbohydrates changes the glucose and insulin response and makes it easier to mobilize fat stores," says study researcher Penny Kris-Etherton, PhD, RD, a distinguished professor of nutritional sciences at Penn State University.

"Visceral fat is more metabolically active and easier to lose than subcutaneous fat, especially if you have plenty of it and the right conditions are met, such as the ones in our study."
When you eat refined foods like white bread, it triggers a series of events, starting with elevated blood sugar levels followed by an increased insulin response, which can cause fat to be deposited more readily. But eating a diet rich in whole grains (which also tend to be higher in fiber) helps improve insulin sensitivity. This, in turn helps the body more efficiently use blood glucose, lowers blood glucose levels, and reduces fat deposition.

The U.S. Department of Agriculture's 2005 Dietary Guidelines recommends that half of your grain servings come from whole grains.

"Eating whole grains exclusively may be difficult and unrealistic for many people," says Rosenbloom. Instead, she recommends, "work toward consuming more whole grains, as they tend to be high in fiber, which satisfies hunger for longer periods and helps you eat less than refined grains."
Can Monounsaturated Fats Banish Belly Fat?

A recent diet book called The Flat Belly Diet posits the idea that you can lose belly fat by eating a 1,600-calorie diet rich in monounsaturated fats.

Most people will lose weight on a 1,600-calorie diet. And there is little question that when it comes to choosing fats, the monounsaturated fatty acids (MUFAS) found in avocados, nuts, seeds, olives, soybeans, chocolate, olive and canola oils are among the best choices, with proven health benefits, such as reducing the risk of heart disease.

But these are not magic foods capable of targeting belly fat, experts note. While the MUFAS are healthy fats, they are still fats, with nine calories per gram -- more than twice that of carbohydrates and proteins, which have four calories per gram.

"Fats have to be controlled, because it is easy to overeat nuts or guacamole -- which can undo the health benefits by packing on the pounds," cautions Rosenbloom.
Can Exercise Flatten Your Abs?

Hundreds of crunches each day won't flatten your belly if you need to lose weight. If your abdominal muscles aren't covered with excess fat, strengthening them can help you look tighter and thinner. But spot exercises won't banish belly fat.

"If you want to lose weight and keep it off, you must eat a healthy, controlled-calorie diet and get regular exercise -- around 60 minutes a day of moderate activity, like brisk walking," says Rosenbloom.

And the harder you exercise, the more belly fat you may lose. Jensen suggests that people who engage in high-intensity aerobic exercise tend to be leaner around the abdomen.
The Risks of Excess Belly Fat

Why is it important to lose belly fat? Carrying around extra pounds in your midsection is serious business. Extra weight in your midsection is more dangerous than fat around your hips and thighs, as visceral fat is worse for your health than the subcutaneous fat that sits under the skin.

"Extra weight around the midsection is associated with inflammation and a higher risk of health problems such as cardiovascular disease, diabetes, metabolic syndrome and more," Jensen says.

According to a recent study in Circulation, belly fat appears to boost inflammation and is linked to hardening of the arteries.
Is Your Middle Too Big?

Beyond the body mass index (BMI), waist circumference has been touted as a simple and reliable test to measure health, weight status, and hidden fat, says Rosenbloom.

To assess your risk, use a soft tape measure. Lie down and wrap it around your natural waistline, located above your hip bone and below your belly button. Take the measurement without holding your breath or holding your stomach in.

If your waist is larger than 40 inches (for men) or 35 inches (for women), you have too much belly fat and are at risk for heart disease and other conditions. And one of the best things you can do for your health is to lose weight, says Rosenbloom.
The Bottom Line About Belly Fat

So what's the bottom line about belly fat?

Most scientific evidence suggests that a calorie-controlled diet rich in fruits, vegetables, whole grains, low-fat dairy, beans, nuts, seeds, lean meat, fish, eggs, and poultry is the foundation for a diet that provides all the nutrients you need while helping to whittle your waistline.

The real secret to losing belly fat is to lose weight on a balanced, calorie-controlled diet and exercise at least an hour a day.
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View Article Sources Sources

SOURCES:

Penny Kris-Etherton, PhD, RD, distinguished professor of nutritional sciences, Penn State University, State College, Pa.

Christine Rosenbloom, PhD, RD, nutrition professor, Georgia State University, Atlanta.

Michael Jensen, MD, professor of medicine, Mayo Clinic, Rochester, Minn.

Katcher, H.I. American Journal of Clinical Nutrition, January 2008; vol 87: pp 79-90.

WebMD Medical News: "Why Belly Fat Hurts the Heart."

WebMD Medical News: "Whole Grains Fight Belly Fat."
Reviewed on March 04, 2008