ALLERGY, RESPIRATORY
Keep Asthma, Allergies at Bay for the Holidays
Folic Acid Might Offer Allergy Relief
Molecule in Skin May Link Eczema and Asthma
ALTERNATIVE MEDICINE
Acupuncture Eases Side Effects of Head, Neck Cancer Treatments
Indian Spice May Thwart Liver Damage
Acupuncture May Trigger Natural Painkiller
ANIMAL CARE
Rest Easy. When It Comes to Swine Flu, Your Pet Is Safe
Animals Respond to Acupuncture's Healing Touch
Beware of Dog Bites
BONES & JOINTS
Body Fat, Muscle Distribution Linked to RA Disability
Brazilian Mint Tea Naturally Good for Pain Relief
Gene Therapy May Ease Rheumatoid Arthritis
CANCER
Minorities Distrust Medical System More
Sharing Cancer Info May Be Empowering
Healthy Behaviors Slow Functional Decline After Cancer
CAREGIVING
Bariatric Surgery Centers Don't Deliver Better Outcomes
Study Links Pesticides to Birth Defects
For Dialysis Patients, More Pills = Lower Quality of Life
CIRCULATORY SYSTEM
Years of Exposure to Traffic Pollution Raises Blood Pressure
Walk 100 Steps a Minute for 'Moderate' Exercise
Grapefruit-Heavy Diet Helped Spur Dangerous Clot
COSMETIC
Wrinkle Fillers Need Better Label Warnings: FDA Panel
With Psoriasis, the Internet May Offer Hope
Study Evaluates Laser Therapies for Hair Removal
DENTAL, ORAL
Gum Disease Might Boost Cancer Risk
Periodontal Disease Impacts Whole Health
Laser Technology Spots Cavities Before They Start
DIABETES
Drug May Not Help Diabetes-Related Eye Damage
Coffee, Tea Might Stave Off Diabetes
Older Diabetics With Depression Face Higher Death Rate
DIET, NUTRITION
Coffee Beans May Be Newest Stress-Buster
Mediterranean Diet May Help Prevent Depression
Is Coffee Good or Bad for Your Health?
DISABILITIES
Could Your Cell Phone Help Shield You From Alzheimer's?
Review Finds Marijuana May Help MS Patients
ENVIRONMENTAL HEALTH
Chemical in Plastics May Cause Fertility Problems
Hairspray Exposure Ups Risk for Birth Defect in Sons
Common Pesticide Tied to Development Delays in Kids
EYE CARE, VISION
Impotence Drugs Don't Harm Vision: Study
Eye Disease, Cognitive Decline Linked in Study
Kids Think Glasses Make Others Look Smart, Honest
FITNESS
Mom and Baby Alike May Benefit From Exercise
Strenuous Daily Workout May Keep Cancer at Bay
Community Exercise Programs Boost Seniors' Strength
GASTROINTESTINAL PROBLEMS
Intestinal Bacteria Trigger Immune Response
Bowel Prep Harder on Women Than Men
New Guidelines Issued for Management of IBS
GENERAL HEALTH
Spread of Swine Flu in Japan Could Raise WHO Alert to Highest Level
A Little Alcohol May Stave Off Alzheimer's
Pesticides and How to Affordably Eat Organic or Reduce Pesticide Consumption
HEAD & NECK
Zen May Thicken Brain, Thwart Pain
Many Children Will Outgrow Headaches
Ski Helmets Encouraged for All
HEALTH & TECHNOLOGY
Magnet Therapy May Ease Hard-to-Treat Depression
Subway Defibrillators Save Lives
E-Mailing Your Way to Healthier Habits
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
Lack of Vitamin D Linked to High Blood Pressure
Fructose Boosts Blood Pressure, Studies Find
INFECTIOUS DISEASE
Hand Washing 10 Times a Day May Help Keep Flu Away
Swine Flu Closes Three Schools in NYC
Swine Flu Loves a Crowd
INFERTILITY
Obesity May Affect Fertility in Young Womene
KID'S HEALTH
Traffic, Dust Linked to Asthma in Kids
Exercise During Pregnancy Keeps Newborn Size Normal
Help Your Kids Stay Active
MEN'S HEALTH
The Dark Side of Vegetarianism
Soy Linked to Low Sperm Count
Eating Fast Until Full Triples Overweight Risk
MENTAL HEALTH
The Unmedicated Mind
A Simple 'Thank You' Brings Rewards to All
Common Social Groups and Race, Seem to Help People Relate
PAIN
Are We Exercising Pain Away? Not So Much.
Alleviating Rheumatoid Arthritis
Acupuncture, Real or Fake, Eases Back Pain
PHYSICAL THERAPY
PREGNANCY
Calcium Supplements Cut Blood Lead Levels During Pregnancy
For Baby and Mom Alike, Breast-Feeding May Be Best
Pre-Pregnancy Weight Linked to Babies' Heart Problems
SENIORS
A Little Alcohol May Stave Off Alzheimer's
Vitamin D May Help Keep Aging at Bay
Protein Deposits May Show Up Before Memory Problems Occur, Study Says
SEXUAL HEALTH
SLEEP DISORDERS
Meditation May Help Put Primary Insomnia to Bed
Better Sleep, Grades Seem to Go Up
Moderate Aerobics May Ease Insomnia Symptoms
WOMEN'S HEALTH
Air Pollution Slows Women's Marathon Times
Broccoli May Help Battle Breast Cancer
Varicose Veins May Mask Larger Problem
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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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