ALLERGY, RESPIRATORY
Know Your Asthma Triggers
New Spray Could Benefit Cystic Fibrosis Patients
Air Quality Better in Northeast, Midwest
ALTERNATIVE MEDICINE
Ginger Can Ease Nausea From Chemotherapy Treatments
When Healing Becomes a Commodity
New Insights Show Ginseng Fights Inflammation
ANIMAL CARE
Safe Toys for Dogs
Beware of Dog Bites
Animals Respond to Acupuncture's Healing Touch
BONES & JOINTS
Soccer's a Winner for Building Bone Health in Girls
Gene Plays Key Role in Clubfoot
Tai Chi May Help Ward Off Knee Pain in Seniors
CANCER
Asthmatics Who Quit Smoking May Reverse Lung Damage
Scams and Shams That Prey on Cancer Patients
Vitamin C Shows Promise as Cancer Treatment
CAREGIVING
3 Steps Might Help Stop MRSA's Spread
Most Women Struggle With Rising Health Care Costs
U.S. Mental Health Spending Rises, But Many Still Left Out
CIRCULATORY SYSTEM
Potassium-Rich Foods May Cut Stroke, Heart Disease Risk
Night Shift Work Hard on the Heart
Varicose Veins May Mask Larger Problem
COSMETIC
Study Evaluates Laser Therapies for Hair Removal
Mouse Study Finds Molecule That Tells Hair to Grow
Health Tip: After Liposuction
DENTAL, ORAL
Biological Product Shows Promise Against Gum Disease
A Sweet Way to Shield Baby's Teeth
Hormones May Be to Blame for Women's Cavity Rates
DIABETES
Chamomile Tea May Ward Off Diabetes Damage
'Standard' Glucose Test May Be Wrong One for Obese Children
Exercise Protects Black Women From Type 2 Diabetes
DIET, NUTRITION
Memory Loss Help from Brain Supplement Prevagen
Go Healthy, Not Hungry for Holiday Eating
Coffee Drinkers Might Live Longer
DISABILITIES
Could Your Cell Phone Help Shield You From Alzheimer's?
Review Finds Marijuana May Help MS Patients
ENVIRONMENTAL HEALTH
'Safe' Ozone Levels May Not Be for Some
Pilots May Face Greater Cancer Risk
Scorpion Anti-Venom Speeds Children's Recovery
EYE CARE, VISION
Kids Think Glasses Make Others Look Smart, Honest
Retinal Gene Is Linked to Childhood Blindness
Nearly 18 Million Will Have Macular Degeneration by 2050
FITNESS
The Juice From Beetroots May Boost Stamina
Avoiding a Holiday Season of Discontent
Exercise Keeps the Brain Young
GASTROINTESTINAL PROBLEMS
Olive Oil May Protect Against Bowel Disease
Bowel Prep Harder on Women Than Men
Peppermint Oil, Fiber Can Fight Irritable Bowel
GENERAL HEALTH
Pay Attention to Signs That Say You're Too Fatigued to Drive
Dry Weather Boosts Odds of Flu Outbreaks
Brisk Walk Can Help Leave Common Cold Behind
HEAD & NECK
Zen May Thicken Brain, Thwart Pain
Many Children Will Outgrow Headaches
Ski Helmets Encouraged for All
HEALTH & TECHNOLOGY
Imaging Sheds Light on How Acupuncture Works
Subway Defibrillators Save Lives
E-Mailing Your Way to Healthier Habits
HEARING
Summer Sounds Can Lead to Hearing Loss
Noise Hurts Men's Hearing More, Study Shows
HEART & CARDIOVASCULAR
Whole Grains Lower Risk of Heart Failure
Implanted Defibrillators Boost Long-Term Survival
A Little Chocolate May Do the Heart Good
INFECTIOUS DISEASE
Swine Flu Now Reported in All 50 States
Chinese 'Devil Dung' Plant Could Be a Swine Flu Fighter
Grapefruit Compound Inhibits Hepatitis C Virus
INFERTILITY
Obesity May Affect Fertility in Young Womene
KID'S HEALTH
Babies Who Eat Fish Lower Eczema Risk
Standard IQ Test May Underestimate People With Autism
Backpack Safety Should Be on Back-to-School Lists
MEN'S HEALTH
Could Chinese Herb Be a Natural Viagra?
Low Iron Levels Cut Cancer Risk in Men With PAD
Low Vitamin D Levels May Boost Men's Heart Attack Risk
MENTAL HEALTH
How to Attack Holiday Stress Head-On
Music Soothes Anxiety as Well as Massage Does
Most Depressed Teens Don't Get Treatment
PAIN
Alleviating Rheumatoid Arthritis
Tai Chi May Help Ease Fibromyalgia
'Cell Phone Elbow' -- A New Ill for the Wired Age
PHYSICAL THERAPY
PREGNANCY
Breast-Feeding May Protect a Woman's Heart
Sleeping Could Help Women Lose The Baby Fat
Exercise Boosts Bone Density in Breast-Feeding Moms
SENIORS
High-Impact Activity May Be Good for Old Bones
Nighttime Urination Linked to Higher Death Rate Among Elderly
Eating Well And Keeping Active As You Grow Old Will Help You Stay Sharp
SEXUAL HEALTH
SLEEP DISORDERS
Exercising Throat Muscles May Relieve Sleep Apnea
Daylight Savings: Not a Bright Time for All
Better Sleep, Grades Seem to Go Up
WOMEN'S HEALTH
Active Young Women Need Calcium, Vitamin D
Spice Compounds May Stem Tumor Growth
Being Active an Hour a Day Puts Brakes on Weight Gain
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Wrinkle Fillers Need Better Label Warnings: FDA Panel

TUESDAY, Nov. 18 (HealthDay News) -- American women who turn to cosmetic treatments called dermal fillers to ease wrinkles must be better informed about the health risks these products pose, an advisory panel to the U.S. Food and Drug Administration recommended Tuesday.

The panel of independent experts urged the agency to revise product labeling to warn of potential reactions to the fillers, including bumps, blotching and scarring.

While side effects are relatively rare, the FDA has also received reports of allergic reactions, including some that were life-threatening, such as anaphylactic shock, the agency said.

"The labeling should be modified to reflect what we're learning further about the products" in various post-marketing studies and elsewhere, panel member Mary McGrath, a professor of surgery at the University of California, San Francisco, told Bloomberg News.

According to The American Society for Aesthetic Plastic Surgery, almost 1,449,000 procedures involving fillers were performed in the United States last year.

The FDA is not bound to follow the recommendations of its advisory panels, although it typically does so.

As part of their review, the group reviewed a variety of reports to see if stronger warning labels were needed for the injectable products. Some fillers are made from natural substances, while others come from synthetic materials. Brand names for some of these products include Restylane, Juvederm, Artefill, and Perlane.

The FDA has also asked the panel to make recommendations on testing the dermal fillers, post-approval follow-up and informing consumers about potential risks. The meeting was spurred by reports of 823 injuries caused by dermal fillers that included allergic reactions, swelling, sores, pain, blisters and cysts.

Overall, 638 patients needed additional medical treatment. Nineteen patients were seen in emergency rooms with life-threatening allergic reactions, such as difficulty breathing. Twelve patients had to be admitted to hospitals due to infections, the FDA said.

Medications used to treat problems ranged from topical steroid creams to multiple courses of oral antibiotics, topical steroids, anti-inflammatory or antihistamine drugs, and intra-lesion steroid injections. Ninety-four of the 823 reported injuries required surgical intervention, ranging from opening an abscess for drainage of pus, to biopsy of lesions, the FDA said.

One of the FDA's concerns is that some of the products are being used in ways that they weren't approved for -- called "off-label use."

"The trouble is that once this material is in the hands of physicians, there's really not much control over how it's used and where it's placed," Dr. Scott Spear, a Washington plastic surgeon, told the AP. "That creates the potential for a certain amount of mischief."

There's limited data on how darker-skinned people may react to the dermal filler treatments. Hispanic, black and Asian patients may develop blotches and other complications, the FDA said.

"Off-label" use of these products may be the cause of some of these problems. Lip enhancement is a common off-label use, the FDA said.

Another concern is what happens to the fillers as they break down and circulate throughout the body. Most of the products appear to cause no problems, but one contains small plastic balls that aren't absorbed by the body, the FDA has noted.

One group representing the nation's plastic surgeons agreed that more study is needed.

"We are going to convene a consensus conference early next year to look at the research priorities, to study long-term, post-market safety and effectiveness of these products," said Dr. Richard D'Amico, immediate past president, American Society of Plastic Surgeons.

The conference will include members of the American Society of Plastic Surgeons as well as representatives from the FDA and manufacturers and other professional groups, he added.

D'Amico, who testified at the meeting Tuesday, believes that post-market studies are essential. "We think it's important to keep looking at products to see how they perform over time," he said. "We are going to continue to monitor these products."

"Right now, their safety and effectiveness is excellent," D'Amico added. "But that doesn't mean we shouldn't keep monitoring to make sure things don't come up."

-Steven Reinberg

More information

For more on cosmetic surgery, visit the American Society of Plastic Surgeons.



SOURCES: Richard D'Amico, M.D., immediate past president, American Society of Plastic Surgeons; U.S. Food and Drug Administration; Nov. 18, 2008, Associated Press, Bloomberg News

Last Updated: Nov. 18, 2008

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