ALLERGY, RESPIRATORY
Molecule in Skin May Link Eczema and Asthma
Traffic, Dust Linked to Asthma in Kids
Overweight Moms More Likely to Have Asthmatic Kids
ALTERNATIVE MEDICINE
Tai Chi: An Ideal Exercise for Many People with Diabetes
Garlic Yields Up Its Health Secret
Spot light on Dani Antman New Lionheart teacher
ANIMAL CARE
'Comfort Dogs' Come to Emotional Rescue
Safe Toys for Dogs
Beware of Dog Bites
BONES & JOINTS
Health Tip: Back Pain in Children
More Faces Being Spared in Motor Vehicle Accidents
Improved Hip Implants Can Last 20 Years
CANCER
More Americans Urged to Get Cancer Screenings
Women Smokers Lose 14.5 Years Off Life Span
Many Ignore Symptoms of Bladder Trouble
CAREGIVING
Depression, PTSD Common Among Lung Transplant Patient Caregivers
Distance No Bar to Kidney Transplants in Remote Areas
Injected Medication Errors a Major Problem
CIRCULATORY SYSTEM
Anemia Rates Down for U.S. Women and Children
Walk 100 Steps a Minute for 'Moderate' Exercise
Laughter Can Boost Heart Health
COSMETIC
What to Do If You Have Unsightly Veins
Contact Lenses Boost Kids' Self-Image
Gum Chewing May Cut Craving for Snacks
DENTAL, ORAL
Study Links Osteoporosis Drugs to Jaw Trouble
Gum Care Helps Control Type 2 Diabetes and Its Complications
Gum Disease May Reactivate AIDS Virus
DIABETES
Lifestyle Factors Tied to Older Adults' Diabetes Risk
Insulin Resistance Tied to Peripheral Artery Disease
Brown Rice Bests White for Diabetes Prevention
DIET, NUTRITION
Pesticides and How to Affordably Eat Organic or Reduce Pesticide Consumption
Uncover Why Turmeric Helps You Heal
Drinking Your Way to Health? Perhaps Not
DISABILITIES
Review Finds Marijuana May Help MS Patients
Could Your Cell Phone Help Shield You From Alzheimer's?
ENVIRONMENTAL HEALTH
Pregnant Rural Women More at Risk
Gene Explains How High-Fructose Diets Lead to Insulin Resistance
Ozone-Depleting Inhalers Being Phased Out
EYE CARE, VISION
Kids Who Spend More Time Outdoors Have Better Vision
Decorative Halloween Eye Lenses May Pose Serious Risks
Antioxidant-Rich Diet May Protect Against Eye Disease
FITNESS
Exercise Key Player in Knee Replacement Recovery
Want to Stop Cancer? You Can, Experts Say
Exercise Cuts Lung Cancer Risk in Ex-Smokers by 45%
GASTROINTESTINAL PROBLEMS
Japanese Herbals May Ease Gastro Woes
Olive Oil May Protect Against Bowel Disease
Gum Chewing May Speed Colon Surgery Recovery
GENERAL HEALTH
15-Point Test Gauges Alzheimer's Risk
Swine Flu Now Reported in All 50 States
Want to Stop Cancer? You Can, Experts Say
HEAD & NECK
Many Children Will Outgrow Headaches
Zen May Thicken Brain, Thwart Pain
Ski Helmets Encouraged for All
HEALTH & TECHNOLOGY
E-Mailing Your Way to Healthier Habits
'Comfort Dogs' Come to Emotional Rescue
The Internet Is Becoming One-Stop Shopping for Health Help
HEARING
Noise Hurts Men's Hearing More, Study Shows
Summer Sounds Can Lead to Hearing Loss
HEART & CARDIOVASCULAR
Walk Long, Slow and Often to Help the Heart
Too Much Red Meat May Shorten Life Span
Dark Chocolate May Lower Stroke Risk
INFECTIOUS DISEASE
Swine Flu Closes Three Schools in NYC
Viral Infection Might Trigger High Blood Pressure
Swine Flu Now Reported in All 50 States
INFERTILITY
Obesity May Affect Fertility in Young Womene
KID'S HEALTH
Frequent Feedings May Be Making Babies Fat
Scary Toxins Make Halloween Face Paints Questionable
Winter's Bitter Cold Poses Health Dangers
MEN'S HEALTH
Whole Grains, Bran May Fight Hypertension in Men
Physical Activity May Prolong Survival After Colon Cancer
Noise Hurts Men's Hearing More, Study Shows
MENTAL HEALTH
17 Ways to Create the Perfect Workday
Optimism May Boost Immune System
Cinnamon Breaks Up Brain Plaques, May Hold Key to Fighting Alzheimer’s
PAIN
Acupuncture, Real or Fake, Eases Back Pain
Are We Exercising Pain Away? Not So Much.
Alleviating Rheumatoid Arthritis
PHYSICAL THERAPY
PREGNANCY
For Baby and Mom Alike, Breast-Feeding May Be Best
Yoga's Benefits Outweigh Risks for Pregnant Women
Breast-Feeding May Protect a Woman's Heart
SENIORS
More Whole Grains May Mean Less Fat
Tai Chi and Qigong Offer Many Health Benefits: Review
Rapid Weight Loss in Seniors Signals Higher Dementia Risk
SEXUAL HEALTH
SLEEP DISORDERS
Pay Attention to Signs That Say You're Too Fatigued to Drive
Better Sleep, Grades Seem to Go Up
Lose Weight, Sleep Apnea May Improve
WOMEN'S HEALTH
Occaisonal Dieting May Cut Breast Cancer, Study Says
Iodine in Prenatal Vitamins Varies Widely
Most Women With Osteoporosis Unaware of Raised Fracture Risk
Add your Article

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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