ALLERGY, RESPIRATORY
'Safe' Ozone Levels May Not Be for Some
Using Music and Sports to Improve Kids' Asthma
Molecule in Skin May Link Eczema and Asthma
ALTERNATIVE MEDICINE
Tai Chi: An Ideal Exercise for Many People with Diabetes
Relaxation Tapes or Mozart Lower Blood Pressure
Could Chinese Herb Be a Natural Viagra?
ANIMAL CARE
'Comfort Dogs' Come to Emotional Rescue
Safe Toys for Dogs
Separation Anxiety, Canine-Style
BONES & JOINTS
Postmenopausal Women With Breast Cancer Face Joint Issues
Most Kids With Type 1 Diabetes Lack Vitamin D
Rheumatoid Arthritis a Threat to the Heart
CANCER
Method for Treating Cervical Lesions May Pose Pregnancy Risks
Red Meat No No No But Oily Fish Yes Yes Yes
Minorities Distrust Medical System More
CAREGIVING
Hospital Volume Imperfect Gauge of Cancer Surgery Outcomes
When the Caregiver Becomes the Patient
MRSA Infections Spreading to Kids in Community
CIRCULATORY SYSTEM
Health Tip: Are You Anemic?
Secondhand Smoke Quickly Affects Blood Vessels
Bad Marriages Harder on Women's Health
COSMETIC
What to Do If You Have Unsightly Veins
With Psoriasis, the Internet May Offer Hope
Get Sugared!.... Its a sweet choice for hair removal
DENTAL, ORAL
Most Insured Adults Worry About Health Care Costs: Poll
Acid Drinks Blamed for Increase in Tooth Erosion
Sports Drinks May Be Tough on Teeth
DIABETES
Treatment for Type 2 Diabetes Updated
Poor Blood Sugar Control After Heart Surgery Impacts Outcomes
Exercise Protects Black Women From Type 2 Diabetes
DIET, NUTRITION
Vitamin D May Help Keep Aging at Bay
Antioxidant-Rich Foods Lose Nutritional Luster Over Time
Lose Weight, Sleep Apnea May Improve
DISABILITIES
Could Your Cell Phone Help Shield You From Alzheimer's?
Review Finds Marijuana May Help MS Patients
ENVIRONMENTAL HEALTH
Pregnant Rural Women More at Risk
Common Pesticide Tied to Development Delays in Kids
Agent Orange Exposure Tied to Prostate Cancer Return
EYE CARE, VISION
Too Much Sun, Too Few Antioxidants Spell Eye Trouble
Eye Test Could Spot Diabetes Vision Trouble Early
Statin Drugs Cause Eye Disorders
FITNESS
Consciousness Helps the Mind and Body Work Together
Avoiding a Holiday Season of Discontent
Want to Stop Cancer? You Can, Experts Say
GASTROINTESTINAL PROBLEMS
Soothing Imagery May Help Rid Some Kids of Stomach Pain
Gum Chewing May Speed Colon Surgery Recovery
New Yogurt May Ease Stomach Ulcers
GENERAL HEALTH
FDA Bans Unapproved Prescription Cough, Cold and Allergy Meds
Coffee Cuts Liver Scarring in Hepatitis C
Toxins May Form When Skin, Indoor Ozone Meet
HEAD & NECK
Zen May Thicken Brain, Thwart Pain
Ski Helmets Encouraged for All
Many Children Will Outgrow Headaches
HEALTH & TECHNOLOGY
The Internet Is Becoming One-Stop Shopping for Health Help
Combating Myths About Seasonal Allergies
'Cell Phone Elbow' -- A New Ill for the Wired Age
HEARING
Noise Hurts Men's Hearing More, Study Shows
Summer Sounds Can Lead to Hearing Loss
HEART & CARDIOVASCULAR
Fish Oil Supplements Help With Heart Failure
Quitting Smoking Doubles Survival in Early Stage Lung Cancer
Estrogen May Help Men's Hearts
INFECTIOUS DISEASE
Swine Flu Is Now a Pandemic Says W.H.O.
Chinese 'Devil Dung' Plant Could Be a Swine Flu Fighter
Dry Weather Boosts Odds of Flu Outbreaks
INFERTILITY
Obesity May Affect Fertility in Young Womene
KID'S HEALTH
6 Million U.S. Kids Lack Enough Vitamin D
Combo Treatment Eases Wheezing in Babies
Most Depressed Teens Don't Get Treatment
MEN'S HEALTH
Exercise May Prevent Prostate Cancer: Study Shows
Lots of Sex May Prevent Erectile Dysfunction
Vigorous Exercise Cuts Stroke Risk for Men, Not Women
MENTAL HEALTH
Fear Response May Stem From Protein in Brain
The 3LS Wellness Program for Reversing Chronic Symptoms and Creating Lasting Health
Breast-Fed Baby May Mean Better Behaved Child
PAIN
Are We Exercising Pain Away? Not So Much.
Acupuncture, Real or Fake, Eases Back Pain
Alleviating Rheumatoid Arthritis
PHYSICAL THERAPY
PREGNANCY
Exercise Boosts Bone Density in Breast-Feeding Moms
Pre-Pregnancy Weight Linked to Babies' Heart Problems
Obesity May Affect Fertility in Young Womene
SENIORS
Living Alone Increases Odds of Developing Dementia
Save Your Aging Brain, Try Surfing The Web
Could Your Cell Phone Help Shield You From Alzheimer's?
SEXUAL HEALTH
SLEEP DISORDERS
Better Sleep, Grades Seem to Go Up
Lose Weight, Sleep Apnea May Improve
Exercising Throat Muscles May Relieve Sleep Apnea
WOMEN'S HEALTH
Flame-Retardant Chemical Linked to Conception Problems
Varicose Veins May Mask Larger Problem
Women Smokers Lose 14.5 Years Off Life Span
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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