ALLERGY, RESPIRATORY
Using Music and Sports to Improve Kids' Asthma
Herbal Remedy Could Halt Peanut Allergy
Keep Asthma, Allergies at Bay for the Holidays
ALTERNATIVE MEDICINE
Memory Loss Help from Brain Supplement Prevagen
Bitter Melon Extract May Slow, Stop Breast Cancer
Cranberries May Help Prevent Urinary Tract Infections
ANIMAL CARE
'Comfort Dogs' Come to Emotional Rescue
Safe Toys for Dogs
Rest Easy. When It Comes to Swine Flu, Your Pet Is Safe
BONES & JOINTS
Drinking Cuts Rheumatoid Arthritis Risk
New Clues to How Fish Oils Help Arthritis Patients
Using a Balloon to Repair a Broken Back
CANCER
Women Smokers Lose 14.5 Years Off Life Span
Lifting Weights Can Ease Arm Swelling in Breast Cancer Survivors
Papaya Could Be a Cancer Fighter
CAREGIVING
Baby's Sleep Position May Not Affect Severity of Head Flattening
Many Hospital Patients Can't ID Their Doctors
More Than 60,000 Patients Risked Hepatitis Infections
CIRCULATORY SYSTEM
Salt Boosts Blood Pressure in High-Risk Patients
Health Tip: Are You Anemic?
Varicose Veins May Mask Larger Problem
COSMETIC
Gum Chewing May Cut Craving for Snacks
Wrinkle Fillers Need Better Label Warnings: FDA Panel
What to Do If You Have Unsightly Veins
DENTAL, ORAL
Scientists Find Gene for Tooth Enamel
Sports Drinks May Be Tough on Teeth
Acid Drinks Blamed for Increase in Tooth Erosion
DIABETES
Americans Consuming More Sugary Beverages
Diabetes Linked to Cognitive Problems
Whole Grains Take a Bite Out of Type 2 Diabetes Risk
DIET, NUTRITION
Occaisonal Dieting May Cut Breast Cancer, Study Says
Healthy Eating While On Vacation
Probiotics Are The Good Guys
DISABILITIES
Review Finds Marijuana May Help MS Patients
Could Your Cell Phone Help Shield You From Alzheimer's?
ENVIRONMENTAL HEALTH
Air Pollution Exposure May Slow Fetal Growth
Topical Drugs May Pollute Waterways
Childhood Food Allergies on the Rise
EYE CARE, VISION
Gene-Transfer Proves Safe for Vision Problem
Sports Eye Injuries Leading Cause of Blindness in Youths
Brain Pressure More Likely to Cause Vision Loss in Men
FITNESS
Being Active an Hour a Day Puts Brakes on Weight Gain
Diet, Exercise May Slow Kidney Disease Progression
Living With Less TV, More Sweat Boosts Weight Loss
GASTROINTESTINAL PROBLEMS
Gum Chewing May Speed Colon Surgery Recovery
HRT Use Raises Risk of Stomach Trouble
New Yogurt May Ease Stomach Ulcers
GENERAL HEALTH
Simple Exercise Precautions To Help Keep Baby Boomers Fit
Bacterial Infections May Succumb to Honey
Uncover Why Turmeric Helps You Heal
HEAD & NECK
Many Children Will Outgrow Headaches
Zen May Thicken Brain, Thwart Pain
Ski Helmets Encouraged for All
HEALTH & TECHNOLOGY
'Comfort Dogs' Come to Emotional Rescue
Airport Full Body Scanners Pose No Health Threat: Experts
Imaging Sheds Light on How Acupuncture Works
HEARING
Noise Hurts Men's Hearing More, Study Shows
Summer Sounds Can Lead to Hearing Loss
HEART & CARDIOVASCULAR
Heart Disease May Be Prevented By Taking Fish Oils, Study Shows
Western Diet Linked To Heart Disease, Metabolic Syndrome
Soy Protein Doesn't Lower Cholesterol
INFECTIOUS DISEASE
Chinese 'Devil Dung' Plant Could Be a Swine Flu Fighter
The HPV Vaccine: Preventative Medicine or Human Sacrifice?
Bacterial Infections May Succumb to Honey
INFERTILITY
Obesity May Affect Fertility in Young Womene
KID'S HEALTH
Winter's Bitter Cold Poses Health Dangers
Don't Leave Your Kids In The Car !
Scorpion Anti-Venom Speeds Children's Recovery
MEN'S HEALTH
Exercise May Prevent Prostate Cancer: Study Shows
Sunlight May Help Protect Men From Kidney Cancer
Noise Hurts Men's Hearing More, Study Shows
MENTAL HEALTH
Environmental Chemicals May Affect Male Reproduction
Keeping Mentally Active Seems To Keep The Brain Active
Fear Response May Stem From Protein in Brain
PAIN
Tai Chi May Help Ease Fibromyalgia
'Cell Phone Elbow' -- A New Ill for the Wired Age
Acupuncture, Real or Fake, Eases Back Pain
PHYSICAL THERAPY
PREGNANCY
Music of Mozart Soothes the Preemie Baby
Breast-Feeding May Protect a Woman's Heart
Pregnant Women Exposed To Certain Pollutants Could Lower Childs IQ
SENIORS
Vitamin D May Help Keep Aging at Bay
Laughter Can Stimulate a Dull Appetite
A Little Alcohol May Stave Off Alzheimer's
SEXUAL HEALTH
SLEEP DISORDERS
Exercising Throat Muscles May Relieve Sleep Apnea
Pay Attention to Signs That Say You're Too Fatigued to Drive
Lose Weight, Sleep Apnea May Improve
WOMEN'S HEALTH
Air Pollution Slows Women's Marathon Times
Sugary Colas Tied to Gestational Diabetes
Natural Therapies for Menopause
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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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